Textile tube for a therapeutic device
A circular woven tubular structure and controllable motor-blower system enhance patient compliance and effectiveness in respiratory treatment devices by ensuring consistent pressure and comfort, addressing fit and usability issues in existing devices.
Patent Information
- Application Number
- JP2025179931
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-02-13
- Filing Date
- 2025-10-24
- Publication Date
- 2026-01-23
AI Technical Summary
Existing respiratory treatment devices, such as masks and interfaces, face challenges with comfort, compliance, ease of use, and effectiveness due to poor fit, discomfort, and complexity, leading to reduced patient adherence and therapeutic outcomes.
A patient interface with a circular woven tubular structure and a controllable motor-blower system that maintains therapeutic pressure, includes a seal-forming structure and positioning stabilizer, and allows for seamless airflow, enhancing comfort and compliance.
The solution improves patient compliance and therapeutic effectiveness by providing a comfortable, easy-to-use, and effective respiratory treatment device that maintains pressure throughout the respiratory cycle.
Smart Images

Figure 2026012243000001_ABST
Abstract
Description
[Technical Field]
[0001] 1 Cross-reference to related applications This application claims the benefit of U.S. Provisional Application No. 62 / 805,164, filed February 13, 2019, which is incorporated herein by reference in its entirety.
[0002] 2. Technical Background 2.1 Technology field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof. [Background technology]
[0003] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and oral cavity form the entrance to a patient's airways.
[0004] These airways contain a series of branching tubes that become narrower, shorter, and more numerous the deeper they travel into the lungs. The primary function of the lungs is gas exchange, allowing oxygen from the air to enter the venous blood and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. Gas exchange occurs in the alveolar region of the lung, which is called the respiratory region. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.
[0005] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.
[0006] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases.
[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of upper airway closure or obstruction during sleep. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected individuals to experience breathing pauses typically lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This can result in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. This condition is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Patent No. 4,944,310 (Sullivan).
[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory regulator, characterized by alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with recurrent sleep arousals, which can cause severe insomnia, increased sympathetic nervous activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).
[0009] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:
[0010] Patients with respiratory failure (a type of respiratory insufficiency) may experience abnormal shortness of breath during exercise.
[0011] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.
[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics, including increased resistance to air movement, prolonged expiratory phase of breathing, and a decrease in normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.
[0013] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle impairment, resulting in the inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be categorized as rapidly progressive or slowly progressive: (i) rapidly progressive disorders, characterized by muscle impairment that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle impairment that worsens over years and results in only a modest reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.
[0014] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive obstruction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.
[0015] A range of treatments are available to treat or ameliorate these conditions, and preventative treatments for respiratory disease are also available to benefit otherwise healthy individuals. However, these suffer from several deficiencies.
[0016] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above respiratory disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).
[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that continuous positive airway pressure acts as a pneumatic splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing closure of the upper airway. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to adhere to treatment if they perceive one or more of the following about the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.
[0018] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing and / or maintain adequate oxygen levels in the body by performing some or all of the respiratory functions. Ventilatory support is provided through a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.
[0019] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.
[0020] 2.2.3 Treatment System These treatments may be provided by therapeutic systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.
[0021] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.
[0022] 2.2.3.1 Patient Interface A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may form a seal with, for example, an area of the patient's face, thereby facilitating gas delivery at a pressure sufficient to disperse with atmospheric pressure for therapy implementation (e.g., at a positive pressure of about 10 cmH2O relative to atmospheric pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airways at a positive pressure of about 10 cmH2O.
[0023] Certain other mask systems may be functionally inadequate in this field. For example, masks intended for purely decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.
[0024] Certain masks may be clinically unsuitable for this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).
[0025] In certain masks, the patient must insert part of the mask structure into their mouth and create and maintain a seal via their lips, which may be uncomfortable or impractical in this technology.
[0026] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).
[0027] There are multiple challenges in designing a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the chin or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.
[0028] These challenges can lead to one or more of the following: some masks can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if worn for extended periods or if the patient is unfamiliar with the system. If the wrong size mask is used, this can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be durable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with treatment. This is especially true if the mask must be worn while sleeping.
[0029] CPAP therapy is highly effective in treating certain respiratory conditions when patients comply with the therapy. However, if the mask is uncomfortable or difficult to use, patients may not comply. Patients are often encouraged to clean their masks regularly, but if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean the mask, which may affect patient compliance.
[0030] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.
[0031] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.
[0032] 2.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.
[0033] 2.2.3.1.2 Positioning and stabilization The seal-forming structures of patient interfaces used in positive air pressure therapy are subjected to corresponding forces of air pressure that disrupt the seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.
[0034] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to implement one or more of the above-mentioned therapies, for example, by actuating the device to generate a flow of air delivered to an interface with the airway. This flow of air can be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.
[0035] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient's airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.
[0036] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (e.g., whether the patient adheres to one or more "compliance rules" with their RPT device). An example of a compliance rule for CPAP therapy may require a patient to use the RPT device for at least four hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.
[0037] There may be other aspects of patient care that benefit from communication of treatment data to third parties or external systems.
[0038] Existing processes for communicating and managing such data can be costly, time consuming, and / or error prone.
[0039] 2.2.3.5 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient). [Prior art documents] [Patent documents]
[0040] [Patent Document 1] U.S. Patent No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 Summary of the Invention [Means for solving the problem]
[0041] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.
[0042] A first aspect of the present technology relates to devices used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disease.
[0043] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.
[0044] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.
[0045] One form of the present technology relates to an apparatus for providing positive pressure respiratory therapy to a patient breathing a respiratory cycle including an inhalation portion and an exhalation portion, the apparatus comprising a controllable motor blower configured to generate a supply of air at a positive pressure relative to ambient pressure by rotating an impeller at an impeller speed, and to cause the supply of air at a positive pressure, in use, to be delivered from the motor blower to a patient interface via an air circuit comprising a tubular structure.
[0046] One form of the present technology relates to a patient interface comprising: 1) a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; 2) a seal-forming structure constructed and arranged to form a seal against an area of the patient's face surrounding an entrance to the patient's airways, the seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least entrances to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; 3) a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie constructed and arranged to rest at least a portion of the tie against a region of the patient's head above the superior ear-base point in use; and 4) a tubular structure for delivering air to the plenum chamber, the tubular structure having a circular woven structure.
[0047] One form of the present technology comprises an air circuit for use in an air therapy device. The air circuit may include a tubular structure. The tubular structure may have a circular woven structure. The tubular structure may be seamless along the length of the tubular structure. The tubular structure may include a plurality of warp yarns and a plurality of weft yarns. The tubular structure may include a first weft position, a second weft position, a third weft section with at least one weft position, and a fourth weft position. The plurality of weft yarns may include a first weft yarn and a second weft yarn. The first weft yarn may be disposed at the first weft position adjacent to a second weft yarn at the second weft position. The first weft yarn may be a first monofilament strand, and the second weft yarn may be a second monofilament strand. The second weft yarn may be adjacent to at least one multifilament yarn of the third weft section. The first weft yarn may be disposed at the fourth weft position.
[0048] The plurality of weft yarns may include a first monofilament weft yarn and a second monofilament weft yarn. The first monofilament weft yarn may be disposed adjacent to at least one non-monofilament weft yarn, and the second monofilament weft yarn may also be disposed adjacent to at least one non-monofilament weft yarn. The at least one non-monofilament yarn may be disposed between the first monofilament weft yarn and the second monofilament weft yarn.
[0049] In embodiments, (a) the first monofilament strand may have a diameter of 0.7 millimeters, (b) the plurality of warp yarns may include 252 warp yarns, (c) the outer diameter of the tubular structure may be greater than 18 millimeters, (d) the third weft section may comprise at least four weft positions, (e) the plurality of warp yarns may be formed of the same material, (f) the at least four weft positions may comprise a first weft position, a second weft position, a third weft position, and a fourth weft position, (g) the first yarn composition at the first weft position may be the same as the fourth yarn composition at the fourth weft position, and (h) the second yarn composition at the second weft position may be the same as the third yarn composition at the third weft position.
[0050] Another aspect of one form of the present technology includes an air circuit. The air circuit may include a tubular structure. The tubular structure may have a circular woven structure. The tubular structure may be seamless along the length of the tubular structure. The tubular structure may include a plurality of warp yarns and a plurality of weft yarns. The plurality of weft yarns may include a first monofilament weft yarn and a second monofilament weft yarn. The first monofilament weft yarn may be disposed adjacent to at least one non-monofilament weft yarn. The second monofilament weft yarn may also be disposed adjacent to at least one non-monofilament yarn. The at least one non-monofilament yarn may be disposed between the first monofilament weft yarn and the second monofilament weft yarn.
[0051] In an embodiment according to the preceding paragraph, (a) the first monofilament strand may have a diameter of 0.7 millimeters, (b) the plurality of warp yarns may include 252 warp yarns, (c) the outer diameter of the tubular structure may be greater than 18 millimeters, (d) the third weft section may include at least four weft positions, (e) the plurality of warp yarns may be formed of the same material, (f) the at least four weft positions may include a first weft position, a second weft position, a third weft position, and a fourth weft position, and (g) the first yarn composition at the first weft position is the same as the fourth yarn composition at the fourth weft position. (h) the second yarn composition at the second weft position may be the same as the third yarn composition at the third weft position; (i) the first non-monofilament yarn at the first weft position may have the same composition as the fourth non-monofilament yarn at the fourth weft position; (j) the second non-monofilament yarn at the second weft position may have the same composition as the third non-monofilament yarn at the third weft position; and (k) the first non-monofilament yarn may be disposed adjacent to the first monofilament yarn and the fourth non-monofilament yarn may be disposed adjacent to the second monofilament yarn.
[0052] In one embodiment, the air circuit may be included in a device that provides positive pressure respiratory therapy to a patient breathing through a respiratory cycle including an inhalation portion and an exhalation portion. The device may include a controllable motor-blower configured to generate a positive pressure of air relative to ambient pressure by rotating an impeller at an impeller speed. The device may include a housing that holds the motor-blower. The housing may include an inlet and a patient connection port. The patient connection port may be structured to deliver the supply of air at the positive pressure from the motor-blower through the air circuit to a patient interface during use. The device may include a sensor for monitoring at least one of the pressure and flow rate of the air supply at the positive pressure and generating a sensor output. The device may include a controller configured to adjust operating parameters of the motor-blower in response to the sensor output to maintain a minimum positive pressure in the patient interface during a therapy session by increasing the impeller speed during the inhalation portion of the respiratory cycle and decreasing the impeller speed during the exhalation portion of the respiratory cycle.
[0053] In one embodiment, the air circuit is included in a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airways. The seal-forming structure has holes therein through which the airflow at the therapeutic pressure is delivered to at least the entrances to the patient's nares. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may include a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a tie. The tie may be constructed and arranged to at least partially cover an area of the patient's head above the superior ear base point in use. The patient interface may include a vent structure for allowing a continuous flow of gases exhaled by the patient from within the plenum chamber to the ambient atmosphere. The vent structure may be sized and shaped to maintain a therapeutic pressure within the plenum chamber during use. The patient interface may be configured to allow the patient to breathe from the atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface may be configured to leave the patient's oral cavity exposed.
[0054] Another aspect of this form of technology includes a tubular structure for delivering air to a plenum chamber. The tubular structure may have a circular woven structure and may include an outer surface and an inner surface. The tubular structure may have a circular woven structure with a weft density of at least 30 threads per 10 cm and at least 168 warp threads per 10 cm. The tubular structure may include a first weft yarn that is stiffer than an adjacent second weft yarn. The first weft yarn may resist closure of the tubular structure when subjected to a vertical force. The first yarn may be positioned between the warp yarns such that the first yarn is embedded in the woven structure of the tubular structure. The tubular structure may further include a sealing structure having an outer surface lining the inner surface of the tubular structure. The inner surface may form a boundary of a channel in the tubular structure for directing air. The channel is configured to deliver air at a therapeutic pressure with a non-zero leakage rate.
[0055] In an embodiment according to the preceding paragraph, (a) the tubular structure may include 252 warp yarns; (b) the tubular structure may be formed continuously and seamlessly along the entire length of the tubular structure; and (c) the tubular structure may include at least two separate monofilament strands in the weft direction, a first monofilament strand disposed adjacent to a second monofilament strand.
[0056] In one example, the tubular structure may be included in a device for providing positive pressure respiratory therapy to a patient breathing through a respiratory cycle including an inhalation portion and an exhalation portion. The device may include a controllable motor-blower configured to generate air at a positive pressure relative to ambient pressure by rotating an impeller at an impeller speed. The device may include a housing for holding the motor-blower. The housing may include an inlet and a patient connection port. The patient connection port may be structured to deliver the supply of air at the positive pressure from the motor-blower through an air circuit to a patient interface during use. The device may include a sensor for monitoring at least one of the pressure and flow rate of the air supply at the positive pressure and generating a sensor output. The device may include a controller configured to adjust operating parameters of the motor-blower in response to the sensor output to maintain a minimum positive pressure in the patient interface during a therapy session by increasing the impeller speed during the inhalation portion of the respiratory cycle and decreasing the impeller speed during the exhalation portion of the respiratory cycle.
[0057] In one embodiment, the tubular structure may be included in a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airways. The seal-forming structure may have holes therein through which the airflow at the therapeutic pressure is delivered to at least the entrances to the patient's nares. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may include a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a tie. The tie may be constructed and arranged to at least partially cover an area of the patient's head above the superior ear base point in use. The patient interface may include a vent structure for allowing a continuous flow of gases exhaled by the patient from within the plenum chamber to the ambient atmosphere. The vent structure may be sized and shaped to maintain a therapeutic pressure within the plenum chamber during use. The patient interface may be configured to allow the patient to breathe from the atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface may be configured to leave the patient's oral cavity exposed.
[0058] Another aspect of one form of the present technology includes an air circuit. The air circuit may include a seamless woven tubular structure. The air circuit may include an outer surface of the tubular structure that may be ribbed. A rib structure having peaks and valleys may be formed. Weft yarns disposed in the peaks may have a different elasticity than weft yarns disposed in the valleys.
[0059] In the embodiment according to the preceding paragraph, (a) the weft yarn arranged in the peak portion may have lower elasticity than the weft yarn arranged in the valley portion, and (b) the weft yarn between the peak portion and the valley portion may have elasticity intermediate between the elasticity of the weft yarn arranged in the peak portion and the elasticity of the weft yarn arranged in the valley portion.
[0060] Another aspect of one form of the present technology includes an air circuit. The air circuit may include a sealing structure that covers the inner surface of the tubular structure to reduce air loss through the tubular structure. The weight of the sealing structure may be less than 75% of the weight of the tubular structure.
[0061] In embodiments according to the preceding paragraph, (a) the sealing structure may be formed of silicone, (b) the sealing structure may be formed of acrylate, (c) the sealing structure may be applied to the inner surface via spraying, (d) the sealing structure may be formed separately and adhered to the inner surface, and (e) the tubular structure may be woven over the sealing structure.
[0062] Another aspect of one form of the present technology includes an air circuit. The air circuit may include a seamless woven tubular structure. The air circuit may include an outer surface of the tubular structure, which may be ribbed, and an inner surface of the tubular structure, which may be ribbed. The air circuit may include a sealing structure covering the inner surface of the tubular structure to reduce air loss through the tubular structure. The weight of the sealing structure may be less than 75% of the weight of the tubular structure.
[0063] In an embodiment according to the preceding paragraph, (a) the tubular structure may be a circular woven structure including monofilament and non-monofilament yarns; (b) the air circuit may be configured to deliver air to the patient at a therapeutic pressure and may be configured to have a leakage rate of less than 2.5 mL / min per meter when delivering air at the therapeutic pressure; (c) the tubular structure may be formed of a different material than the sealing structure; (d) the sealing structure may be formed of an elastomeric material; (e) a portion of the inner surface of the tubular structure may have a positive curvature of a first magnitude, the sealing structure having an inner surface and an outer surface, the outer surface of the sealing structure may have a negative curvature of a first magnitude adjacent to the portion of the inner surface, and the inner surface of the sealing structure may have a positive curvature of the first magnitude; (f) the sealing structure may be consistent along a length of the inner surface of the tubular structure from the first rib to the second rib, and a thickness of the sealing structure may be substantially constant along the length from the first rib to the second rib.
[0064] In one embodiment, the air circuit may be included in a device that provides positive pressure respiratory therapy to a patient breathing through a respiratory cycle including an inhalation portion and an exhalation portion. The device may include a controllable motor-blower configured to generate a positive pressure of air relative to ambient pressure by rotating an impeller at an impeller speed. The device may include a housing that holds the motor-blower. The housing may include an inlet and a patient connection port. The patient connection port may be structured to deliver the supply of air at the positive pressure from the motor-blower through the air circuit to a patient interface during use. The device may include a sensor for monitoring at least one of the pressure and flow rate of the air supply at the positive pressure and generating a sensor output. The device may include a controller configured to adjust operating parameters of the motor-blower in response to the sensor output to maintain a minimum positive pressure in the patient interface during a therapy session by increasing the impeller speed during the inhalation portion of the respiratory cycle and decreasing the impeller speed during the exhalation portion of the respiratory cycle.
[0065] In one embodiment, the air circuit is included in a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airways. The seal-forming structure has holes therein through which the airflow at the therapeutic pressure is delivered to at least the entrances to the patient's nares. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may include a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a tie. The tie may be constructed and arranged to at least partially cover an area of the patient's head above the superior ear base point in use. The patient interface may include a vent structure for allowing a continuous flow of gases exhaled by the patient from within the plenum chamber to the ambient atmosphere. The vent structure may be sized and shaped to maintain a therapeutic pressure within the plenum chamber during use. The patient interface may be configured to allow the patient to breathe from the atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface may be configured to leave the patient's oral cavity exposed.
[0066] Another aspect of one form of the present technology comprises an apparatus for providing positive pressure respiratory therapy to a patient breathing through a respiratory cycle including an inhalation portion and an exhalation portion. The apparatus may include a controllable motor-blower configured to generate a positive pressure of air relative to ambient pressure by rotating an impeller at an impeller speed. The apparatus may include a housing for holding the motor-blower. The housing may include an inlet and a patient connection port. The patient connection port may be structured to deliver the supply of air at the positive pressure from the motor-blower through an air circuit to a patient interface during use. The apparatus may include a sensor for monitoring at least one of a pressure and a flow rate of the air supply at the positive pressure and for generating a sensor output. The apparatus may include a controller configured to adjust operating parameters of the motor-blower in response to the sensor output to maintain a minimum positive pressure in the patient interface during a therapy session by increasing the impeller speed during the inhalation portion of the respiratory cycle and decreasing the impeller speed during the exhalation portion of the respiratory cycle. The air circuit may include a tubular structure. The tubular structure may have a circular woven structure. The tubular structure may be seamless along its length. The tubular structure may include a plurality of warp yarns and a plurality of weft yarns. The plurality of weft yarns may include a first monofilament weft yarn and a second monofilament weft yarn. The first monofilament weft yarn may be disposed adjacent to at least one non-monofilament weft yarn. The second monofilament weft yarn may also be disposed adjacent to at least one non-monofilament yarn. The at least one non-monofilament yarn may be disposed between the first monofilament weft yarn and the second monofilament weft yarn.
[0067] In an embodiment according to the preceding paragraph, (a) the first monofilament strand may have a diameter of 0.7 millimeters, (b) the plurality of warp yarns may include 252 warp yarns, (c) the outer diameter of the tubular structure may be greater than 18 millimeters, (d) the third weft section may include at least four weft positions, (e) the plurality of warp yarns may be formed of the same material, (f) the at least four weft positions may include a first weft position, a second weft position, a third weft position, and a fourth weft position, and (g) the first yarn composition at the first weft position is the same as the fourth yarn composition at the fourth weft position. (h) the second yarn composition at the second weft position may be the same as the third yarn composition at the third weft position; (i) the first non-monofilament yarn at the first weft position may have the same composition as the fourth non-monofilament yarn at the fourth weft position; (j) the second non-monofilament yarn at the second weft position may have the same composition as the third non-monofilament yarn at the third weft position; and (k) the first non-monofilament yarn may be disposed adjacent to the first monofilament yarn and the fourth non-monofilament yarn may be disposed adjacent to the second monofilament yarn.
[0068] Another aspect of one form of the present technology includes a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways. The seal-forming structure has holes therein whereby the airflow at the therapeutic pressure is delivered to at least the entrances to the patient's nares. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may include a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a tie. The tie may be constructed and arranged to at least partially cover an area of the patient's head above the superior ear-base point in use. The patient interface may include a vent structure for allowing a continuous flow of gas exhaled by the patient from the interior of the plenum chamber to the surroundings. The vent structure may be sized and shaped to maintain a therapeutic pressure within the plenum chamber during use. The patient interface may be configured to allow the patient to breathe from the atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface may be configured to leave the patient's oral cavity exposed. A tubular structure for delivering air to the plenum chamber may have a circular woven structure and may include an outer surface and an inner surface. The tubular structure may have a circular woven structure with a weft density of at least 30 threads per 10 cm and at least 168 warp threads per 10 cm. The tubular structure may include a first weft yarn that is stiffer than an adjacent second weft yarn. The first weft yarn may resist closure of the tubular structure when subjected to a vertical force. The first yarn may be disposed between the warp yarns such that the first yarn is integrated into the woven structure of the tubular structure.The tubular structure may further include a sealing structure having an outer surface lining an inner surface of the tubular structure, the inner surface may form a boundary of a channel in the tubular structure for directing air, the channel configured to deliver air at a therapeutic pressure with a non-zero leakage rate.
[0069] In an embodiment according to the preceding paragraph, (a) the tubular structure may include 252 warp yarns; (b) the tubular structure may be formed continuously and seamlessly along the entire length of the tubular structure; and (c) the tubular structure may include at least two separate monofilament strands in the weft direction, a first monofilament strand disposed adjacent to a second monofilament strand.
[0070] Another aspect of one form of the present technology comprises an apparatus for providing positive pressure respiratory therapy to a patient breathing through a respiratory cycle including an inhalation portion and an exhalation portion. The apparatus may include a controllable motor-blower configured to generate air at a positive pressure relative to ambient pressure by rotating an impeller at an impeller speed. The apparatus may include a housing for holding the motor-blower. The housing may include an inlet and a patient connection port. The patient connection port may be structured to deliver the supply of air at the positive pressure from the motor-blower through an air circuit to a patient interface during use. The apparatus may include a sensor for monitoring at least one of a pressure and a flow rate of the air supply at the positive pressure and for generating a sensor output. The apparatus may include a controller configured to adjust operating parameters of the motor-blower in response to the sensor output to maintain a minimum positive pressure in the patient interface during a therapy session by increasing the impeller speed during the inhalation portion of the respiratory cycle and decreasing the impeller speed during the exhalation portion of the respiratory cycle. The air circuit may include a seamless woven tubular structure. The air circuit may include an outer surface of the tubular structure, which may be ribbed, and an inner surface of the tubular structure, which may be ribbed. The air circuit may include a sealing structure covering the inner surface of the tubular structure to reduce air loss through the tubular structure. The weight of the sealing structure may be less than 75% of the weight of the tubular structure.
[0071] In an embodiment according to the preceding paragraph, (a) the tubular structure may be a circular woven structure including monofilament and non-monofilament yarns; (b) the air circuit may be configured to deliver air to the patient at a therapeutic pressure and may be configured to have a leakage rate of less than 2.5 mL / min per meter when delivering air at the therapeutic pressure; (c) the tubular structure may be formed of a different material than the sealing structure; (d) the sealing structure may be formed of an elastomeric material; (e) a portion of the inner surface of the tubular structure may have a positive curvature of a first magnitude, the sealing structure having an inner surface and an outer surface, the outer surface of the sealing structure may have a negative curvature of a first magnitude adjacent to the portion of the inner surface, and the inner surface of the sealing structure may have a positive curvature of the first magnitude; (f) the sealing structure may be consistent along a length of the inner surface of the tubular structure from the first rib to the second rib, and a thickness of the sealing structure may be substantially constant along the length from the first rib to the second rib.
[0072] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.
[0073] One aspect of the present technology is a method for manufacturing a device.
[0074] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or acumen, or individuals with limited experience using such medical devices.
[0075] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).
[0076] An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.
[0077] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor in a special purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatus enable advancements in the art of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).
[0078] Of course, some of the above aspects may form sub-aspects of the present technology, and various sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.
[0079] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Additional note 1] 1. An apparatus for providing positive airway pressure therapy to a patient breathing through a respiratory cycle including an inhalation portion and an exhalation portion, the apparatus comprising: a controllable motor blower configured to rotate an impeller at an impeller speed to generate air at a positive pressure relative to ambient pressure; a housing for holding the motor blower, the housing including an inlet and a patient connection port, the patient connection port configured to deliver the positive pressure supply of air from the motor blower through an air circuit to a patient interface in use; a sensor for monitoring at least one of the pressure and flow rate of the air supply when under positive pressure and generating a sensor output; a controller configured to adjust operating parameters of the motor blower in response to the sensor output to maintain a minimum positive pressure within said patient interface during a therapy session by increasing the impeller speed during the inhalation portion of the breathing cycle and decreasing the impeller speed during the exhalation portion of the breathing cycle; an air circuit, the air circuit comprising: comprising a tubular structure, the tubular structure has a circular woven structure; the tubular structure is seamless along the length of the tubular structure; the tubular structure includes a plurality of warp yarns and a plurality of weft yarns; the plurality of weft yarns include a first monofilament weft yarn and a second monofilament weft yarn; the first monofilament weft yarn is disposed adjacent to at least one non-monofilament weft yarn, and the second monofilament weft yarn is also disposed adjacent to at least one non-monofilament yarn; The at least one non-monofilament yarn is disposed between a first monofilament weft yarn and a second monofilament weft yarn. [Additional note 2] 10. The device of claim 1, wherein the first monofilament weft yarn has a diameter of 0.7 millimeters. [Additional note 3] 3. The apparatus of claim 1, wherein the plurality of warp threads includes 252 warp threads. [Additional note 4] 4. The device according to any one of claims 1 to 3, wherein the outer diameter of the tubular structure is greater than 18 millimeters. [Additional note 5] 5. The device according to any one of appended items 1 to 4, wherein the at least one non-monofilament yarn includes four non-monofilament yarns. [Additional note 6] The device of claim 5, wherein the at least four non-monofilament yarns include a first weft position, a second weft position, a third weft position, and a fourth weft position. [Additional note 7] 7. The apparatus of claim 6, wherein the first non-monofilament yarn composition at the first weft position is the same as the fourth non-monofilament yarn composition at the fourth weft position. [Additional note 8] 8. The apparatus of claim 7, wherein the second non-monofilament yarn composition at the second weft position is the same as the third non-monofilament yarn composition at the third weft position. [Additional note 9] The device of claim 8, wherein the first non-monofilament yarn can be positioned adjacent to the first monofilament yarn, and the fourth non-monofilament yarn is positioned adjacent to the second monofilament yarn. [Additional Note 10] A patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that, in use, at least a portion of the tie rests against a region of the patient's head above an upper ear base point; a venting structure that allows continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; where: the patient interface is configured to allow the patient to breathe from atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed; A tubular structure for delivering air to a plenum chamber, the tubular structure having a circular woven structure and including an outer surface and an inner surface; the tubular structure has a circular woven structure with a weft density of at least 30 threads per 10 cm and at least 168 warp threads per 10 cm; the tubular structure includes a first weft yarn that is stiffer than an adjacent second yarn; the first weft yarns resist closure of the tubular structure when subjected to a vertical force; the first weft yarn is positioned between the warp yarns such that the first weft yarn is incorporated into the woven structure of the tubular structure; a sealing structure having an outer surface lining an inner surface of the tubular structure, the inner surface forming a boundary of a channel of the tubular structure for guiding air; A patient interface, wherein the channel is configured to deliver air at a therapeutic pressure with a non-zero leak rate. [Additional Note 11] 11. The patient interface of claim 10, wherein the weft density is about 40 threads per 10 cm. [Additional Note 12] 12. The patient interface of claim 10 or 11, wherein the tubular structure comprises 252 warp threads. [Additional Note 13] 13. The patient interface of any one of clauses 10 to 12, wherein the tubular structure is formed continuously and seamlessly along the entire length of the tubular structure. [Additional Note 14] 14. The patient interface of any one of clauses 10 to 13, wherein the tubular structure comprises at least two separate monofilament strands in a weft direction, a first monofilament strand disposed adjacent to a second monofilament strand. [Additional Note 15] 1. An apparatus for providing positive airway pressure therapy to a patient breathing through a respiratory cycle including an inhalation portion and an exhalation portion, the apparatus comprising: a controllable motor blower configured to rotate an impeller at an impeller speed to generate air at a positive pressure relative to ambient pressure; a housing for holding the motor blower, the housing including an inlet and a patient connection port, the patient connection port configured to deliver the positive pressure supply of air from the motor blower through an air circuit to a patient interface in use; a sensor for monitoring at least one of the pressure and flow rate of the air supply when under positive pressure and generating a sensor output; a controller configured to adjust operating parameters of the motor blower in response to the sensor output to maintain a minimum positive pressure within said patient interface during a therapy session by increasing the impeller speed during the inhalation portion of the breathing cycle and decreasing the impeller speed during the exhalation portion of the breathing cycle; an air circuit, the air circuit comprising: a seamless woven tubular structure; an outer surface of the tubular structure that is ribbed; and an inner surface of the tubular structure that is ribbed. a sealing structure covering the inner surface of the tubular structure to reduce air loss through the tubular structure; A device wherein the weight of the sealed structure is less than 75% of the weight of the tubular structure. [Additional Note 16] 16. The device of claim 15, wherein the tubular structure is a circular woven structure comprising monofilament and non-monofilament yarns. [Additional Note 17] 17. The device of claim 15 or 16, wherein the air circuit is configured to deliver air to the patient at a therapeutic pressure, and the air circuit is configured to have a leakage rate of less than 2.5 mL / min per meter when delivering air at the therapeutic pressure. [Additional Note 18] 18. The device according to any one of claims 15 to 17, wherein the tubular structure is formed of a different material from the sealed structure. [Additional Note 19] 19. The device according to any one of claims 15 to 18, wherein the sealing structure is formed of an elastomeric material. [Additional Note 20] 20. The device according to any one of appended claims 15 to 19, wherein a portion of the inner surface of the tubular structure has a positive curvature of a first magnitude, the sealed structure has an inner surface and an outer surface, the outer surface of the sealed structure has a negative curvature of a first magnitude adjacent to a portion of the inner surface, and the inner surface of the sealed structure has a positive curvature of the first magnitude. [Additional Note 21] 21. The device of any one of appended claims 15 to 20, wherein the sealing structure is aligned along the length of the inner surface of the tubular structure from the first rib to the second rib, and the thickness of the sealing structure is substantially constant along the length from the first rib to the second rib.
[0080] 4 Brief description of the drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: [Brief explanation of the drawings]
[0081] [Figure 1A] 4.1 Treatment System: A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C]The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] Diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] A front view of the face including several features of the surface anatomy including upper lip, vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also indicated. [Figure 2D] A lateral view of the head including several features of the surface anatomy, including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior ear base points. The directions of superior and inferior, anterior and posterior are also indicated. [Figure 2E]
[0023] Figure 1 is a further lateral view of the head, showing the approximate locations of the Frankfort horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G] FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I]The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the septal cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull, including the frontal, nasal, and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] This is a side view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L] An anterior lateral view of the nose is shown. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in 3C. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] Schematic cross-section of a structure cut at a point, where the outward normal at this point is shown and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. 3F. [Figure 3F] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3G]1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The linear distance between A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] 3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A view of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V]A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, the midsagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, where the cross-section is taken in the midsagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the midsagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the midsagittal plane and contacts the cushion of the plenum chamber only at two points on the midsagittal plane (i.e., superior point 3220 and inferior point 3230). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X] The plenum chamber 3200 of Figure 3U is shown in a use position on the face. The midsagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3230 resting on the upper lip. 4.4 RPT Device [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] 1 is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the air pressure path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] 4.5 Humidifier [Figure 5A]
[0023] Fig. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] 5 shows an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Air Circuit [Figure 6] 14 shows an air circuit connecting to a patient interface in accordance with one form of the present technology. [Figure 7] 1 shows a kinked air circuit during use of the treatment device. [Figure 8] 13 shows an air circuit during use of a treatment device by a patient in accordance with one form of the present technology. [Figure 9] 14 illustrates a patient using a treatment device including an air circuit and a patient interface in accordance with one form of the present technology. [Figure 10] FIG. 10 is an enlarged view showing how the air circuit flexes when subjected to force from the patient. [Figure 11] 14 shows one form of an air circuit in accordance with one form of the present technology. [Figure 12] FIG. 1 is a top view of a loom according to one embodiment of the present technology. [Figure 13] FIG. 1 is a side view of a loom according to one embodiment of the present technology. [Figure 14] 1 shows a woven structure in accordance with one aspect of the present technology. [Figure 15] 14 shows a portion of a tubular structure in accordance with one form of the present technology. [Figure 16] 14 shows a portion of a tubular structure in accordance with one form of the present technology. [Figure 17] 13 shows a portion of a tubular structure in a curved position in accordance with one form of the present technology. [Figure 17A] An enlarged portion of the tubular structure is shown. [Figure 18] 13 shows a portion of a tubular structure under tension in accordance with one form of the present technology. [Figure 19] FIG. 1 is a schematic diagram illustrating a portion of a configuration of a tubular structure according to an embodiment of the present technology. [Figure 20] 13 shows a portion of another configuration of a tubular structure in accordance with one aspect of the present technology. [Figure 21] FIG. 10 is a schematic diagram illustrating a portion of another configuration of a tubular structure in accordance with an embodiment of the present technology. [Figure 22] FIG. 10 is a schematic diagram illustrating a portion of another configuration of a tubular structure in accordance with an embodiment of the present technology. [Figure 23] FIG. 10 is a schematic diagram illustrating a portion of another configuration of a tubular structure in accordance with an embodiment of the present technology. [Figure 24] FIG. 10 is a schematic diagram illustrating a portion of another configuration of a tubular structure in accordance with an embodiment of the present technology. [Figure 25] 1 is a table showing various yarn compositions. [Figure 26] 1 is a table showing various shuttle configurations for tubular structures having various thread configurations. [Figure 27] 13 shows a tubular structure formed with a quantity of warp yarns in accordance with one form of the present technology. [Figure 28] 13 shows a tubular structure formed with a second amount of warp yarns in accordance with one form of the present technology. [Figure 29] 13 shows a tubular structure formed with a third amount of warp yarns in accordance with one form of the present technology. [Figure 30] FIG. 10 is a schematic diagram showing a portion of a tubular structure having a first weft density in accordance with one form of the present technology. [Figure 31] FIG. 10 is a schematic diagram showing a portion of a tubular structure having a second weft density in accordance with one form of the present technology. [Figure 32] FIG. 10 is a schematic diagram showing a portion of a tubular structure having a third weft density in accordance with one form of the present technology. [Figure 33] FIG. 13 is a schematic diagram showing a portion of a tubular structure and a sealing structure in accordance with one form of the present technology. [Figure 34] FIG. 13 is a schematic diagram showing a portion of a tubular structure and a sealing structure in accordance with one form of the present technology. [Figure 35] 1 is a selection matrix showing various thread and shuttle configurations. DETAILED DESCRIPTION OF THE INVENTION
[0082] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.
[0083] The following description is provided in connection with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.
[0084] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including applying positive pressure to the entrance of the airways of a patient 1000.
[0085] In certain embodiments of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.
[0086] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.
[0087] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of disordered breathing. The apparatus or device may include an RPT device 4000 that supplies pressurized air to the patient 1000 via an air circuit 4170 to a patient interface 3000.
[0088] 5.3 Patient Interface A non-invasive patient interface 3000 in accordance with one aspect of the present technology includes the following functional features: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. In use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.
[0089] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.
[0090] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.
[0091] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.
[0092] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.
[0093] 5.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).
[0094] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.
[0095] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use.
[0096] 5.3.2 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.
[0097] In one form, the positioning and stabilizing structure 3300 provides at least enough holding force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.
[0098] In one form, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the attractive force on the patient interface 3000.
[0099] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate any potential destructive effects on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).
[0100] In one form of the present technology, there is provided a positioning and stabilizing structure 3300 configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.
[0101] 5.3.3 Ventilation In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases (eg, carbon dioxide).
[0102] 5.3.4 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a ball socket).
[0103] 5.3.5 Connection Port The connection port 3600 allows connection to the air circuit 4170 .
[0104] 5.4 RPT Device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an airflow that is delivered to a patient's airway for treatment of, for example, one or more of the respiratory conditions described anywhere herein.
[0105] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.
[0106] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions: an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.
[0107] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor and a flow sensor).
[0108] One or more of the air path items may be disposed within a removable, unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.
[0109] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202.
[0110] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In an alternative, one or more of the following components may be arranged as their own separate units.
[0111] 5.4.1.1 Air filters An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.
[0112] In one form, the inlet air filter 4112 is located at the beginning of the air pressure path upstream of the pressure generator 4140 .
[0113] In one form, an outlet air filter 4114 (eg, an antibacterial agent) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.
[0114] 5.4.1.2 Mufflers An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.
[0115] In one form of the present technology, an inlet muffler 4122 is positioned above a pressure generator 4140 in the pneumatic path.
[0116] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.
[0117] 5.4.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers housed within a blower housing, for example, in a volute. The blower may deliver the air supply at a rate of, for example, up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, 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 WO 2013 / 020167.
[0118] The pressure generator 4140 is under the control of the therapy device controller.
[0119] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.
[0120] 5.4.1.4 Converters The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves data RPT device).
[0121] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).
[0122] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.
[0123] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass, or band-pass filtering).
[0124] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).
[0125] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000).
[0126] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.
[0127] In some forms, the air circuit 4170 can include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements can take the form of a heated wire circuit and can include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit can be spirally wound around the axis of the air circuit 4170. The heating elements can be in communication with a controller (e.g., central controller 4230). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated by reference in its entirety. As shown in FIG. 6, a patented interface 3000 is attached to or coupled to the air circuit 4170.
[0128] During use of the treatment device, the air circuit 4170 may cause discomfort to the user. For example, the air circuit 4170 may be dragged or pulled along the patient interface and / or RPT device 4000. The weight and / or flexibility or rigidity of the air circuit 4170 may affect the magnitude of the impact the RPT device 4000 and / or patient interface 3000 are subjected to from the air circuit 4170. For example, if the air circuit 4170 is attached to the patient interface 3000 and the RPT device 4000 and is a rigid device, movement of the patient wearing the patient interface 3000 may transmit forces through the air circuit 4170, causing movement of the RPT device 4000 and / or movement of the patient interface 3000. The increased flexibility of the air circuit 4170 allows the air circuit 4170 to contract or expand with patient movement, allowing the air circuit 4170 to absorb tension and reduce the forces induced on the RPT device and / or patient interface compared to a more rigid air circuit 4170.
[0129] Additionally, the weight of the air circuit 4170 can cause discomfort to the patient and can also contribute to drag associated with the air circuit 4170. When moving around, the weight of the air circuit 4170 can interfere with the patient's natural movement, causing discomfort to the patient. Furthermore, a heavier air circuit 4170 will affect the patient interface 3000 and RPT device 4000 when moving compared to a lighter air circuit 4170. A lighter air circuit 4170 may increase comfort and therefore increase the likelihood that the patient will continue to receive treatment. By creating a lightweight air circuit 4170, the patient may not feel the weight of the air circuit 4170 and may be able to move more freely.
[0130] Additionally, as the patient moves around, the air circuit 4170 may twist or bend. In some forms, as depicted in FIG. 7 , the air circuit 4170 may kink, preventing air from passing through or reducing airflow through the air circuit 4170. If the air circuit 4170 kinks and stops or reduces airflow to the patient, the patient may not receive enough air for treatment and may wake up. A patient who wakes up due to a kink may stop using the treatment device. Therefore, a kink-resistant air circuit 4170 may increase the patient's likelihood of continuing to receive treatment.
[0131] 8, a patient may be positioned in a variety of positions while using a treatment device. An air circuit 4170 that can bend and rotate to accommodate such movement may be more comfortable for the patient than other forms of air circuit. Additionally, an air circuit that can bend and twist may provide superior performance compared to other air circuits that may twist when bent or twisted.
[0132] When receiving treatment, the patient may move, such as while sleeping. In some cases, the patient may rest on the air circuit 4170. For example, as shown in FIG. 9, the patient 1000 may wrap the air circuit 4170 under their arm, exerting a force downward or perpendicular to the air circuit 4170. Such a force may cause the air circuit 4170 to occlude or reduce its cross-sectional area, stopping or reducing airflow to the patient interface 3000. This may cause the patient to wake up while using the treatment device. If the patient continues to wake up while using the treatment device, the patient may stop using the device. Configuring the air circuit 4170 to resist occlusion, as depicted in FIG. 10, may allow air to continue to flow to the patient interface 3000 so that the patient continues to receive appropriate treatment. As shown in FIG. 10, the air circuit 4170 may be configured to flex to accommodate the patient's arm. 10, the air circuit 4170 is not a rigid structure, but is sufficiently rigid to resist collapse of the air circuit 4170 and continue to provide pressurized air to the patient. Such a configuration may increase the likelihood that the patient will continue to use the treatment device.
[0133] A patient may also discontinue use of a treatment device if the materials from which the various components of the air circuit 4170 are formed are uncomfortable to the patient. For example, an abrasive material that can rub against the patient's skin may cause the patient to discontinue use of the device. Soft materials such as cotton and absorbent materials such as polyester feel good against the skin and may increase the likelihood that a patient will continue using a treatment device made of comfortable materials.
[0134] The particular arrangement of such materials, such as in woven, non-woven, braided, knitted, or other fiber networks, can also enhance comfort while maintaining the integrity of the air circuit 4170 and encouraging the patient to continue using the treatment device.
[0135] In addition to providing comfort to the patient, the air circuit 4170 can also be configured to be airtight. Forming the air circuit 4170 as an airtight tube allows for consistent and accurate delivery of air to the patient for therapy. The air circuit 4170 can be formed using a woven structure formed into a tubular shape to form a tubular structure. In some configurations, the tubular structure can be coated with silicone or acrylate, or other sealing materials, such as biocompatible materials. In other configurations, an airtight tube, such as a silicone tube, can be woven over the woven tubular structure. In yet another configuration, the woven tubular structure can be placed over an airtight tube, such as a sock-like silicone tube. The tubular structure can be secured together so that the tubular structure and the airtight tube are integrally formed.
[0136] In addition to providing an airtight tube, the silicone or other sealing member may assist in managing humidity and condensation within the air circuit 4170. The inclusion of a sealing layer may prevent condensation from seeping through the tubular structure. A patient may discontinue use of a treatment device if the air circuit 4170 becomes damp or wet. Therefore, the sealing member may assist in maintaining consistent use by the patient by providing a dry exterior surface for the air circuit 4170.
[0137] In some forms, the air circuit 4170 may include additional features that attach to the RPT device 4000 as well as the patient interface 3000. As depicted in FIG. 11 , the air circuit 4170 is shown separate from the RPT device 4000 and the patient interface 3000. As shown, the air circuit 4170 includes a tubular structure 4600 as well as a connector 4670 and a connector 4672. In some forms, the connector 4670 may be configured to connect to the RPT device 4000, and the connector 4672 is configured to connect to the patient interface 3000 so that air can flow from the RPT device 4000 to the patient interface 3000. In some forms, these connectors are permanently attached to the tubular structure 4600; however, in other forms, these connectors may be removable from the tubular structure 4600, for example, for cleaning. The connections between the air circuit 4170 and other components of the air treatment device may be changed or modified depending on the design of the device. For example, press-fit connections, clip connections, or other connections may be utilized.
[0138] The tubular structure 4600 may be formed of a woven, braided, knit, or non-woven structure. Additionally, the tubular structure 4600 may include provisions for forming an airtight tube for transporting pressurized air from the RPT device 4000 to the patient interface 3000.
[0139] 5.5.1 Loom In some forms of the present technology, a variety of machines may be utilized to form the tubular structure used in the air circuit 4170. Such machines include circular braiding machines, circular knitting machines, circular looms, and the like. Additionally, while described herein as forming a continuous tubular structure, machines that form flat fabrics or other materials may be utilized to form a web of interlocking fibers. For example, flat knitting machines or plain looms may be utilized. To form the tubular structure, the flat material may be wrapped and sewn or otherwise secured. As described in this specification, a circular loom has been utilized.
[0140] 12 and 13, a circular loom 4700 is depicted. The loom 4700 includes multiple shuttles, such as one to three shuttles. Additionally, four to six shuttles may be utilized. In yet other configurations, more than six shuttles may be utilized, such as six to twelve shuttles. For example, in FIG. 12, six shuttles 4702 are utilized, on which bobbins 4704 are disposed to hold yarns that are deposited between the warp yarns used to form the tubular structure 4600. While six shuttles 4702 are depicted, other configurations may utilize more or fewer shuttles. As depicted, the loom 4700 includes a first shuttle 4710, a second shuttle 4711, a third shuttle 4712, a fourth shuttle 4713, a fifth shuttle 4714, and a sixth shuttle 4715. The shuttle 4702 deposits weft yarns 4606 between warp yarns 4604 that are fed into the loom 4700 (see FIG. 14 ). The weft yarns 4606 are woven between the warp yarns 4606 to form a tubular structure 4600. As such, the tubular structure 4600 may be formed continuously and seamlessly along its length. This tubular structure 4600, formed in a circular woven configuration, may be pulled off the loom 4700 and wound onto a wheel or cut off for further processing.
[0141] Utilizing a particular number of shuttles and bobbins affects the woven structure formed by the loom 4700. Because the loom 4700 includes a shuttle 4702 that rotates on a track, the pattern of yarns located within the shuttle 4702 will repeat along the length of the tube formed by the loom 4700. For example, a first yarn type may be placed on the bobbins of the first shuttle 4710, the second shuttle 4711, and the third shuttle 4712. A second, different yarn type may be placed on the bobbins of the fourth shuttle 4713, the fifth shuttle 4714, and the sixth shuttle 4715. As the loom 4700 is used, a weft yarn pattern is formed that repeats along the length of the tubular structure formed by the loom 4700. For example, a first yarn type may be placed at three adjacent weft positions, and a second yarn type may be placed at three adjacent weft positions. This pattern continues along the length of the tubular structure. It should be recognized that the starting point of the pattern can vary. For example, if the yarn configuration in shuttle 4702 is the same as described above, the weft pattern of the structure formed by that yarn may begin with two yarns of a first yarn type, followed by three yarns of a second yarn type, and end with one yarn of the first yarn type.
[0142] As illustrated, this pattern subset may vary depending on where the start of the pattern is determined. Additionally, smaller pattern subsets may exist. For example, the bobbin on the first shuttle 4710 may contain a yarn of a first yarn type, the bobbin on the second shuttle 4711 may contain a yarn of a second yarn type, the bobbin on the third shuttle 4712 may contain a yarn of the first yarn type, the bobbin on the fourth shuttle 4713 may contain a yarn of the first yarn type, the bobbin on the fifth shuttle 4714 may contain a yarn of the second yarn type, and the bobbin on the sixth shuttle 4715 may contain a yarn of the first yarn type. In this example, the weft yarn pattern on the tubular structure formed by the loom 4700 may include a first yarn type, a second yarn type, and the first yarn type. Thus, this pattern may be considered a three-yarn pattern. However, this pattern can also be considered a first yarn type, a second yarn type, a first yarn type, a first yarn type, a second yarn type, and a first yarn type. Therefore, this pattern can also be considered a six weft yarn pattern.
[0143] 12 and 13, the operation of the loom 4700 is depicted. As shown in FIG. 12, warp threads 4604 extend generally vertically out of the page. The warp threads 4604 may remain generally stationary laterally during the formation of the tubular structure 4600. However, the warp threads 4604 may be pulled out, i.e., pulled vertically out of the page, during the formation of the tubular structure 4600. While shown with six warp threads, in some configurations, the loom 4700 may include 168, 252, or 336 warp threads. In other configurations, the loom 4700 may include between 50 and 500 warp threads. The shuttle 4702 carries yarns deposited as weft threads. The weft threads are deposited between the warp threads 4604. For example, as shown in FIG. 13, a sixth shuttle 4715 deposits weft threads 4609 between the warp threads 4604. After six shuttles 4715 have passed, the warp threads 4606 may alternate sides so that the next thread deposited is woven between the warp threads 4604. This operation continues until the desired length of the tubular structure 4600 is formed. In this manner, weft threads are deposited between the warp threads. By utilizing multiple warp threads, the weft threads may be substantially covered by the warp threads. In this manner, the weft threads may be spaced from the inner and outer surfaces of the tubular structure 4600. Therefore, if the weft threads are formed of a plastic material such as polyamide, the warp threads may cover the weft threads, preventing the patient from experiencing the feel of the polyamide weft threads against their skin.
[0144] In some embodiments, the speed at which various procedures are performed affects the structure of the tubular structure 4600. For example, conveying speed, or pull-off speed, can refer to the speed at which the tubular structure 4600 is pulled away from the loom 4700. As shown, conveying direction 4750 is the direction in which the tubular structure 4750 is pulled or tensioned. Varying the conveying speed can change the structure of the tubular structure 4600 by altering the weft density in the tubular structure 4600. For example, a higher conveying speed may deposit fewer weft yarns compared to a lower conveying speed. Additionally, varying the shuttle speed can affect the structure of the tubular structure 4600. Shuttle speed can refer to the speed at which the shuttle 4702 moves around the loom 4700. The faster the shuttle 4702 moves, the higher the weft density of the tubular structure 4600. Therefore, the conveying speed and shuttle speed can be varied to form a particular tubular structure 4600 .
[0145] In some embodiments, the tension in the weft yarns 4606 and warp yarns 4604 may be modified or changed to form a tubular structure with particular characteristics. In some embodiments, certain yarns fed from the shuttle 4702 may be pulled harder than other yarns fed from the shuttle 4702 during manufacture. By varying the tension in the weft yarns 4606, the shape and other properties of the tubular structure 4600 may be changed or adjusted. In yet other embodiments, the tension in the warp yarns may also be changed or adjusted during manufacture to give the tubular structure 4600 a particular shape or other properties.
[0146] In some forms, the loom 4700 may include provisions for supporting the tubular structure 4600 during manufacturing. In some forms, the loom 4700 may include features such as barbs 4752. As the weft and warp yarns are woven together, they may be forced against the barbs 4752. As such, the barbs 4752 may provide a surface upon which the yarns may rest. In some forms, the barbs 4752 may provide features that define the shape of the tubular structure 4600.
[0147] 5.5.2 Textile structure In one form of the present technology, a woven, fabric, or other fibrous network is utilized in forming the air circuit 4170. This fibrous network may interact to form a tubular structure, such as tubular structure 4600, as shown in FIG. 15. The tubular structure 4600 is depicted as having a generally flat or uniform outer surface. This illustration is for purposes of explanation and visualization of the tubular structure. However, the tubular structure 4600 may be a ribbed structure, as depicted in FIG. 16. In some forms, a flat woven structure may be formed and then sewn along seams to form the tubular structure. In other forms, flat knitting may be used. In a further form, a nonwoven material, such as felt, may be utilized. In yet another form, braiding, circular knitting, or circular weaving may be utilized to form portions of the air circuit 4170, such that a seamless tubular structure 4600 is formed. As depicted in these figures and described in this specification, the tubular structure 4600 is formed using a circular weave, however, as previously mentioned, in other forms of the present technology, a variety of other fiber network interacting forms may be utilized.
[0148] In utilizing a circular weave pattern, yarns or strands extending in either the warp direction (generally vertical) or the weft direction (generally horizontal) may be used. As used throughout this description, yarn may refer to either the weft or the warp. Additionally, the term "yarn" may refer to a strand formed of either monofilament or multifilament fibers. For example, a warp yarn may be formed of multifilament yarn, resulting in a multifilament yarn. However, in other configurations, the warp yarn may be formed of a single monofilament strand or filament, and this single strand may also be referred to as a yarn.
[0149] Referring to FIG. 14 , the woven structure 4602 utilized to form the tubular structure 4600 is depicted in detail. As shown, the woven structure 4602 includes a plurality of warp yarns 4604 and a plurality of weft yarns 4606. The warp yarns 4604 extend generally vertically along the length of the tubular structure 4600. As such, the warp yarns 4604 extend generally parallel to a longitudinal axis extending through the tubular structure 4600. The term "vertical" is used to describe the orientation of the warp yarns 4604 when the tubular structure 4600 is longitudinally oriented in a vertical direction. It should be understood that if the tubular structure 4600 is longitudinally oriented in a horizontal direction, the warp yarns 4604 would be oriented horizontally. The term "vertical" is used to describe the relationship between the warp yarns 4604 and the weft yarns 4606. The term "vertical" is used to describe the orientation of the warp yarns 4604 when the tubular structure 4600 is longitudinally oriented in a vertical direction. It should be understood that if the tubular structure 4600 is oriented longitudinally horizontally, the warp threads 4604 are oriented generally horizontally. The warp threads 4604 are oriented such that each thread extends from the lower edge 4608 to the upper edge 4610 without wrapping around the tubular structure 4600. For example, the warp threads 4605 extend vertically directly from the lower edge 4608 to the upper edge 4610. In this configuration, the warp threads 4605 are positioned at generally the same circumferential position along the length of the tubular structure 4600 rather than wrapping around the circumference of the tubular structure 4600. Although depicted as part of the tubular structure 4600, the same configuration can exist along the length of the tubular structure 4600.
[0150] In contrast, the weft thread 4606 wraps around the circumference of the tubular structure 4600. The weft thread 4606 may start at the lower edge 4608 and end at the upper edge 4610, but does not extend directly from the lower edge 4608 to the upper edge 4610. The weft thread 4606 spirals around the tubular structure 4600 and may serve to provide support to the tubular structure 4600 to prevent the tubular structure 4600 from collapsing on itself. The spiral of the weft thread 4606 and the angle of the spiral are described in more detail below.
[0151] Additionally, while only a portion of the woven structure 4602 of the tubular structure 4600 is depicted in Figure 14, in some embodiments, substantially the entire exterior surface of the tubular structure 4600 includes the woven structure 4602. In other embodiments, more than half of the exterior surface of the tubular structure includes the woven structure 4602. In yet other embodiments, less than half of the exterior surface of the tubular structure 4600 includes the woven structure 4602. The same or similar proportions may apply to other configurations of fiber networks. For example, substantially the entire, more than half, or less than half of the tubular structure 4600 may be formed of a circular knit, circular braid, or nonwoven material.
[0152] Additionally, although described with an upper edge 4610 and a lower edge 4608, it should be recognized that warp threads do not have to extend to either edge to be considered warp threads. For example, the warp threads may terminate away from the edges of the tubular structure 4600.
[0153] In some configurations, the weft yarn 4606 may completely wrap around the tubular structure 4600. For example, the weft yarn 4607 may wrap around the tubular structure 4600 such that the weft yarn 4607 is located at at least two locations along the length of the tubular structure 4600. As shown, the weft yarn 4607 is located at a first weft position 4612 and also at a second weft position 4614 spaced apart from the first weft position 4612. In the configuration depicted in FIG. 14 , five other weft yarns 4606 are located between the weft yarn 4607 at the first weft position 4612 and the weft yarn 4607 at the second weft position 4614. This is in contrast to the warp yarns 4604, which remain at approximately the same circumferential position along the length of the woven structure 4602. That is, the warp yarns 4604 maintain their position along the length of the woven structure 4602. For example, the weft yarns 4605 run generally perpendicularly along the length of the weft yarns 4605 and the woven structure 4602 .
[0154] The weft yarns of a circular woven material extend in a continuous spiral along the length of the material, so that the weft yarns may not be exactly horizontal or perpendicular to the warp yarns. This allows the circular loom to feed the weft yarns continuously without creating breaks in the weft yarn, and allows the weft yarns to be spaced in stages and continuously along the length of the material (here, the tube).
[0155] The angle of the weft yarns 4606 relative to the warp yarns 4604 can be changed depending on several factors and variables. That is, the angle of the helical nature of the weft yarns 4606 can be changed or altered during production by manipulating various components of the loom 4700. For example, changing the speed at which the shuttle 4702 rotates about the loom 4700 can affect the angle at which the weft yarns 4606 are positioned relative to the warp yarns 4604. For a given take-off or carry speed of the warp yarns 4604, rotating the shuttle 4702 more slowly about the loom 4700 will increase the angle A between the warp yarns 4604 and the weft yarns 4606. Similarly, increasing the rotational speed of the shuttle 4702 about the loom 4700 at a given take-off speed will decrease the angle A between the warp yarns 4604 and the weft yarns 4606. The angle between the warp yarns 4604 and the weft yarns 4606 can also be affected by the take-off or transport speed of the warp yarns 4604 through the loom 4700. Increasing the transport speed of the warp yarns 4604 for a given rotational speed of the shuttle 4702 increases the angle A between the warp yarns 4604 and the weft yarns 4606 of the woven structure 4602. Similarly, decreasing the transport speed of the warp yarns 4604 for a given rotational speed of the shuttle 4702 decreases the angle A between the warp yarns 4604 and the weft yarns 4606 of the woven structure 4602. Thus, the angle between the warp yarns 4604 and the weft yarns 4606 can be adjusted during weaving.
[0156] In some embodiments, angle A can be between 0 and 45 degrees. In other embodiments, angle A can be between 0 and 5 degrees or between 0 and 10 degrees. In further embodiments, angle A can be a non-zero angle. In other embodiments, angle A can be between 5 and 25 degrees. In further embodiments, angle A can be between 25 and 45 degrees. In some embodiments, angle A can be greater than 90 degrees. For example, based on the position of angle A shown in FIG. 14 , angle A can be approximately 95 degrees. In other embodiments, angle A can be an angle other than 90 degrees such that the weft yarns 4606 and warp yarns 4604 are not positioned perfectly perpendicular to one another. In other embodiments, angle A can be between 90 and 135 degrees. In further embodiments, angle A can be between 95 and 105 degrees. In other embodiments, angle A can be between 105 and 135 degrees. In further embodiments, angle A can be between 135 and 150 degrees. In further embodiments, angle A can be between 150 and 165 degrees or more.
[0157] The yarn material used to form the air circuit 4170 can be different in the warp and weft directions. In other configurations, the yarn material can be the same. Furthermore, the same type of yarn can be used. For example, the yarns can have the same properties, such as denier (the mass of the yarn in grams per 9,000 meters of length), decitex (the mass of the yarn in grams per 10,000 meters of length), gauge, diameter, texture, insulation, etc. In certain configurations of the present technology, different yarns or monofilament strands are utilized in the weft and warp directions. These different yarns can enable various properties of the tubular structure 4600. For example, the warp yarns can enable stretch and flexibility of the tubular structure 4600. The weft yarns can limit occlusion during use of the tubular structure 4600. Additionally, the tensile strength and hardness of the material can be varied to achieve specific properties in the air circuit 4170.
[0158] In some embodiments, various configurations and arrangements of weft and warp yarns may be utilized. For example, in some embodiments, the weft yarns may be stretchable or elastic in one direction and provide stretch resistance in another direction. Furthermore, in some embodiments, certain locations of the woven structure 4602 may allow for greater stretch compared to other locations of the woven structure 4602. By utilizing strands with different material properties, the characteristics and properties of the woven structure 4602 may be modified or tailored to meet manufacturing needs. In yet other embodiments, the warp yarns may be varied depending on the specific properties desired for the woven structure 4602. For example, the warp yarn 4605 and two adjacent warp yarns may be formed using an inextensible material. At this location, the woven structure 4602 may be substantially inextensible along its length. However, adjacent warp yarns may have different properties that allow for stretch. In this manner, the woven structure 4602 and structures incorporating the woven structure 4602 may have subtle properties, such as stretchability, in specific locations.
[0159] As shown in FIG. 14, the warp threads 4604 and weft threads 4606 are formed with a generally similar size and shape. This configuration is shown for illustrative purposes only. While a woven structure such as that depicted in FIG. 14 may be utilized in the tubular structure 4600, the tubular structure 4600 may utilize various weft threads, such as those depicted in FIGS. 19-24. That is, weft threads of various sizes and materials may be used. Furthermore, while depicted and described utilizing warp threads of the same size, in other configurations, warp threads of different sizes and properties may be utilized.
[0160] As shown in FIG. 14 , the woven structure 4602 depicts a plain weave configuration. That is, the warp and knit yarns cross over and under each other. For example, warp yarn 4605 passes under weft yarn 4607 and the first weft position 4612. It then moves up to pass over the adjacent weft yarn 4605, and then under the next adjacent weft yarn, and so on. The warp yarns adjacent to warp yarn 4605 have the opposite configuration. For example, the adjacent warp yarn passes over weft yarn 4607 at the first weft position 4612, then under the next adjacent weft yarn, and then over the next adjacent weft yarn, and so on. Similarly, the weft yarns follow the same alternating over and under configuration. For example, weft yarn 4607 at the first weft position 4612 passes over warp yarn 4605, then under the next adjacent warp yarn, and then over the next adjacent warp yarn, and so on. The warp yarns adjacent to warp yarn 4605 have the opposite configuration. Other configurations may include weaves such as basket, satin, twill, and combinations of weaves.
[0161] As described herein, when a warp yarn is said to be adjacent to another warp yarn, the adjacent yarn has a different orientation depending on whether it is above or below the weft yarn. For example, warp yarn 4605 is adjacent to warp yarn 4603. However, as previously noted, weft yarn 4607 at first weft position 4612 passes above warp yarn 4605 and below the adjacent warp yarn 4603. However, in other configurations, adjacent warp yarns may both be positioned below or above the same weft yarn. Such a configuration may occur, for example, in a basket weave configuration. It should be recognized that the same or similar configuration applies to weft yarns. That is, when a weft yarn is adjacent to another weft yarn, the adjacent yarn has a different orientation depending on whether it is above or below the warp yarn.
[0162] 5.5.3 Tubular structure The tubular structure 4600 is formed of a woven structure 4602 that includes both warp and weft yarns and forms a portion of the air circuit 4170. As noted above, the tubular structure 4600 may include warp and weft yarns of various sizes and shapes. As shown in FIG. 15 , the tubular structure 4600 is formed with a generally constant inner and outer diameter. The tubular structure 4600 is depicted in FIG. 15 for illustrative purposes to depict an orientation or view that the tubular structure 4600 may exhibit. Although shown with a constant diameter, the tubular structure 4600 may be formed with a variety of diameters along its length.
[0163] The tubular structure 4600 can be formed with a variety of cross-sectional sizes. In some embodiments, the outer boundary of the outer diameter of the tubular structure 4600 is 18 millimeters. In other embodiments, the maximum outer diameter of the tubular structure 4600 is 20 millimeters. In further embodiments, the outer diameter of the tubular structure 4600 is 15 millimeters or less. In other embodiments, the maximum outer diameter of the tubular structure 4600 is greater than 18 millimeters and / or greater than 20 millimeters. For example, the maximum outer diameter can be between 35 and 60 millimeters or between 50 and 80 millimeters. The inner diameter can also include a variety of dimensions. In some embodiments, the inner boundary of the inner diameter of the tubular structure 4600 is about 15 millimeters. In other embodiments, the inner diameter of the tubular structure 4600 can be between 15 and 18 millimeters. In further embodiments, the inner diameter of the tubular structure 4600 can be between 18 and 20 millimeters. In further embodiments, the inner diameter of the tubular structure 4600 is greater than 20 millimeters. For example, the inner diameter of the tubular structure 4600 can be between 20 and 50 millimeters, or between 30 and 75 millimeters. In other configurations, the inner diameter of the tubular structure 4600 is less than 15 millimeters. The inner and outer diameters of the tubular structure 4600 can be modified depending on the amount of air being passed through the air circuit 4170.
[0164] In some embodiments, the diameter of the tubular structure 4600 can be variable along its length. In some embodiments, the tubular structure 4600 can have a variable outer diameter. In other embodiments, the tubular structure 4600 can have a variable inner diameter. In further embodiments, the tubular structure 4600 can have both a variable inner diameter and a variable outer diameter. For example, as shown in FIG. 16 , the inner and outer diameters of the tubular structure 4600 are variable along the length of the tubular structure 4600. In other embodiments, the diameter of the tubular structure 4600 can increase or decrease along the length of the tubular structure 4600. Increasing or decreasing the diameter can affect the structural integrity of the tubular structure 4600 and can also affect airflow through the tubular structure 4600 when used in conjunction with an RPT device. Additionally, the tubular structure 4600 can have a substantially constant inner and / or outer diameter.
[0165] In some embodiments, the tubular structure 4600 may be specifically formed to enhance the bending characteristics of the tubular structure 4600. Referring to FIG. 16 , a portion of the tubular structure 4600 is depicted in side view. As shown, the tubular structure 4600 includes a rib structure 4616. The rib structure 4616 may include ridges 4618 and valleys 4620. The ridges 4618 may have a negative curvature relative to the outer surface of the tubular structure 4600, while the valleys 4620 may have a positive curvature relative to the outer surface of the tubular structure 4600. The opposite configuration exists on the inner surface of the tubular structure. The rib structure 4616 may allow the tubular structure 4600 to bend in certain locations while also providing flexibility and support to the tubular structure 4600 to resist blockage.
[0166] In some embodiments, the threads may have different tensions during production. For example, in some embodiments, the weft threads extending from the bobbins of the shuttle 4702 may have different tensions during production. A first weft thread from a first shuttle 4710 may be deposited between the warp threads 4604 at a first tension. A second weft thread from a second shuttle 4711 may be deposited between the warp threads 4604 at a second, higher tension. Because the second weft thread is deposited at a higher tension, it may tend to contract the size of the tubular structure at the location of the second weft thread. As such, the cross-section of the tubular structure along the location of the second weft thread may be narrower than the cross-section at the location of the first weft thread.
[0167] In one form, varying tensions in the weft yarns during manufacture of the tubular structure 4600 can assist in forming the rib structure as shown in Figure 16. For example, in some forms, the valleys 4620 can be formed using weft yarns that are under greater tension during manufacture than the weft yarns located in the ridges 4618 of the tubular structure 4600.
[0168] In other embodiments, the yarns may have varying elasticities that aid in the formation of the ridges 4618 and valleys 4620. In some embodiments, the weft yarns of the valleys 4620 may have greater elasticity than the weft yarns of the ridges 4618. During manufacturing, the elastic and non-elastic yarns may be tensioned to the same or similar tension. Due to the higher elasticity of the elastic yarns, the elastic yarns may stretch more than the less elastic yarns. When tension from the shuttle is released from the elastic yarns, the elastic yarns may contract to a steady state. This contraction may cause the cross section of the tubular structure 4600 to become smaller in the areas with more elastic yarns compared to the less elastic strands. Therefore, the contraction of the elastic yarns may form the valleys 4620. Because less elastic yarns do not contract as much as the more elastic yarns, the less elastic yarns may be placed in the peaks of the rib structure. Furthermore, the yarns located between the peaks and valleys of the rib may be more elastic than the weft yarns of the peaks and less elastic than the weft yarns of the valleys.
[0169] As shown in FIG. 17 , a portion of the tubular structure 4600 is bent so that the ridges 4618 abut one another along a narrow inner arc 4622. The ridges 4618 provide a stopping point for the narrowness of the arc that may be formed when the tubular structure 4600 is bent. The width and height of the ridges 4618 may affect how narrow the inner arc 4622 may be. For example, a narrow ridge 4618 may form a narrower arc than a wide ridge 4618. Tall or large ridges may also affect the inner arc 4622. For example, tall ridges may abut one another more than short ridges, resulting in a narrower inner arc 4622 than a tall ridge 4618.
[0170] In addition to the size of the ridges 4618, the material utilized within the ridges 4618 can also affect the size and shape of the arc. In configurations in which the ridges 4618 comprise a flexible and / or low strength material, when the ridges 4618 abut one another, the ridges 4618 may simply bend or distort against one another because they do not have sufficient strength to resist the shape change. In these configurations, the tubular structure 4600 may twist along the inner arc 4622. In other configurations, the ridges 4618 may comprise a high strength material that can withstand forces from adjacent ridges such that a smooth, continuous inner arc 4622 is formed during bending.
[0171] In some embodiments, weft yarns of varying diameters may be utilized. In some embodiments, the weft yarns of the ridges 4618 and valleys 4620 may have a larger diameter than the weft yarns extending between the ridges 4618 and valleys 4620. Varying the weft yarn diameters of the valleys 4620 and ridges 4618 may vary the width of the valleys 4620 and ridges 4618. Furthermore, the weft yarn diameter may affect the shape of the tubular structure 4600. In other embodiments, the yarn diameter may vary anywhere. For example, the weft yarn diameter on the slop may be larger than the weft yarn diameter of the valleys 4620 or ridges 4618. In other embodiments, the yarn diameter may vary all along the length of the tubular structure 4600. For example, a weft yarn within a valley may be thicker than the adjacent weft yarns between the valleys. Furthermore, the weft yarn diameters within the slopes may differ from one another.
[0172] 17 , along the inner arc 4622, the ridges 4618 abut one another, while along the outer arc 4624, the ridges 4618 are spaced apart. In this manner, the valleys 4620 are widened so that the ridges 4618 are spaced apart along the outer arc 4624. As such, the length of material in the valleys 4620 between the ridges 4618 affects how much the tubular structure 4600 can bend. For example, if there is less material between each ridge 4618, there is less material available to stretch or flatten to allow the outer arc 4624 to bend tightly. Additionally, if there is more material in the valleys 4620, a narrower outer arc 4624 can be formed.
[0173] In addition to the amount or length of material between the ridges 4618, the material of the valleys 4620 and the ridges 4618 can also change the amount that the tubular structure 4600 can bend. For example, if the material of the valleys 4620 is not stretchable, the valleys 4620 along the outer arc 4624 will resist bending. Similarly, if the material of the valleys 4620 is a stretchable material, the tubular structure 4600 will bend more than if the material was not stretchable.
[0174] FIG. 17A illustrates a possible arrangement of weft yarns 4606 within the tubular structure 4600 depicted in FIG. 17. This arrangement is the same as that depicted in FIG. 20. Weft yarn arrangement 4637, as well as other arrangements depicted in FIGS. 19-24, may be utilized in the tubular structure 4600. As shown, yarns #1 and #5 are disposed within the ridges of the tubular structure 4600. Additionally, yarn #4 is disposed within the valleys 4620 of the tubular structure 4600. Furthermore, yarns #2 and #3 are disposed on slopes extending from the valleys 4620 toward the ridges 4618. As shown in FIG. 17A, the warp yarns extend alongside the weft yarns, thereby binding the weft yarns together with the warp yarns. Various other configurations, including monofilament yarns, multifilament yarns, and any combination of multifilament and multifilament yarns, may also be utilized to form portions of the valleys 4620 and ridges 4618. Furthermore, any combination of the yarn types listed in Table 4632, or other yarns, may be combined in various sequences to form a rib structure, such as the tubular structure 4600 depicted in FIG. 17 . In some embodiments, a rib structure may be formed by utilizing weft yarns with different elasticities. For example, in some embodiments, a less elastic weft yarn may be positioned along the ridges of the rib structure. Additionally, the weft yarns located in the valleys may have a higher elasticity than the weft yarns located in the peaks. Furthermore, the weft yarns located between the peaks and valleys may have an elasticity intermediate between the elasticity of the weft yarns located in the peaks and the valleys.
[0175] In some forms, the tubular structure 4600 may be specifically formed to enhance the extensibility of the tubular structure 4600. As shown in FIG. 18 , the tubular structure 4600 is subjected to a tensile force 4630. The tensile force 4630 stretches the material of the valleys 4620 and ridges 4618, partially flattening the tubular structure 4600. Forming the tubular structure 4600 with ridges and valleys may allow the material used to form the ridges 4618 and valleys 4620 to stretch or flatten. Compared to tubular structures with constant or linear outer and / or inner surfaces, the tubular structure 4600 may be able to elongate to a greater extent. The flexibility and extensibility of the tubular structure 4600 may allow a patient to be comfortable while utilizing an RPT device that uses the tubular structure 4600.
[0176] 5.5.3.1 Weave In some embodiments, the tubular structure may be woven in a particular manner to achieve particular properties within the air circuit 4170. In some embodiments, a 1:1 plain weave, satin weave, twill weave, basket weave, or leno weave may be utilized. A plain weave may be utilized for stability and includes weft yarns alternating above and below the warp yarns. A leno weave may be utilized to lock fibers within a particular weave structure. A satin weave may be utilized to enhance contours or to impart a particular feel to the weave structure. A twill weave may be utilized to achieve a particular appearance while maintaining the stability of the weave structure. A basket weave may be utilized to achieve flexibility while maintaining strength. As described in this specification, the weave structure of the tubular structure is a 1:1 plain weave. In other embodiments, various weaves such as those described above or combinations thereof may be utilized.
[0177] In other configurations, various types of constructions can be utilized to form the tubular structure 4600. For example, as previously discussed, the tubular structure 4600 can be formed using other manufacturing methods, including knitting, braiding, or interlocking fiber braids. In such configurations, a variety of braids, braids, and other configurations can be used.
[0178] 5.5.3.2 Warp In some embodiments, the warp threads may be formed of specific yarns. In some embodiments, the fiber braid includes yarns or strands of material that may be of monofilament or multifilament construction. In one form of the present technology, the warp threads are formed of elastic polyurethane fibers such as Lycra®. In some embodiments, the warp threads may also include a coating, such as a polyester coating. These materials may impart specific properties to the tubular structure 4600.
[0179] The warp threads can be made of a variety of materials. In some embodiments, the warp threads can be made of natural or synthetic materials. For example, in some embodiments, the warp threads can be made of cotton, wool, or silk. In other embodiments, the warp threads can be made of elastane, rayon, polyester, polyurethane, plastic, or other synthetic materials. The warp threads can also be a combination of different materials. For example, in some embodiments, the warp threads can be made of a combination of synthetic and natural materials. In other embodiments, each thread can be made entirely of natural or synthetic materials, but natural and synthetic threads can be used to form the tubular structure. In further embodiments, the threads can be made of a combination of fibers of different natural or synthetic materials. For example, a particular thread can be made of both cotton and wool fibers. Additionally, a particular thread can be made of polyester and elastane fibers. Furthermore, threads made of certain materials can be used to form the tubular structure. For example, a first yarn can be made of polyester and a second yarn can be made of elastane. These various yarns can be used to enhance or degrade certain properties of the tubular structure. For example, certain materials can be used to enhance comfort, while other materials can be used to enhance the stretchability of the tubular structure. In other configurations, yarns of various decitex values can be used. Additionally, the yarns can be formed using various numbers of fibers and twists. Furthermore, the yarns can be formed using various twists (e.g., S-twisted and Z-twisted) as well as various numbers of twists per unit length.
[0180] In some embodiments, the number of warp threads utilized may be specifically selected to provide a sufficient and consistent seal along the exterior surface of the tubular structure 4600. In some embodiments, 252 warp threads may be utilized. In other embodiments, 168 warp threads may be utilized. In further embodiments, 336 warp threads may be utilized. In further embodiments, 50 to 168 threads may be utilized. In other embodiments, 168 to 252 warp threads may be utilized. In further embodiments, 252 to 336 warp threads may be utilized. Additionally, more than 336 warp threads may be utilized.
[0181] Varying the number of warp threads can alter the properties of the tubular structure 4600. For example, a tubular structure 4600 of a given size containing 168 warp threads can be more flexible than an air circuit of the same size containing 336 warp threads. Similarly, a tubular structure containing 336 warp threads can form a tighter structure than a tubular structure formed using 168 warp threads. By increasing the number of warp threads of the same material, the tubular structure can have greater structural integrity while forming a tighter air circuit than an air circuit containing 168 warp threads.
[0182] Referring to Figures 27-29, various different configurations of tubular structures 4600 are depicted as freestanding. As shown, each tubular structure 4600 is supported by a pin 4601. The tubular structures are designed to flow downward under their own weight. As shown, the tubular structure 4600 of Figure 27 is formed using 168 warp threads. The tubular structure 4600 of Figure 28 is formed using 252 warp threads. The tubular structure 4600 of Figure 29 is formed using 336 warp threads. As previously mentioned, the number of warp threads in the tubular structure 4600 affects many properties of the tubular structure 4600, including the bending force and tendency of the tubular structure 4600. As shown in Figures 27-29, each variation of the tubular structure 4600 is supported in the middle by a pin 4601, allowing the tubular structure to naturally bend in response to its own weight. That is, each is designed to bend under its own weight. As shown, these various tubular structures bend at different angles depending on the number of warp threads in the warp direction. Increasing the number of warp threads reduces the natural curvature of the tubular structure 4600. As shown, the tubular structure 4600 of FIG. 27, which includes 168 warp threads, has a steeper or sharper curvature compared to the tubular structures 4600 of FIGS. 28 and 29, which include 252 and 336 warp threads, respectively. While specific warp thread counts are shown, the number of warp threads can be varied to achieve different bending characteristics. For example, tubular structures can be formed with 168 to 252 warp threads. Such tubular structures have curvatures between those shown in FIGS. 27 and 28. Increasing the number of warp threads to approach 168 will result in tubular structures with properties closer to the tubular structure 4600 of FIG. 27. Including a number of warp threads approaching 252 creates a tubular structure that bends under its own weight, similar to tubular structure 4600 of Figure 28. The number of warp threads utilized can range from 252 to 336. The properties of tubular structure 4600 vary depending on the number of warp threads. Additionally, some configurations utilize more than 353 warp threads, while others utilize fewer than 168 warp threads.
[0183] Additionally, varying the number of warp threads can affect the weave density of the tubular structure 4600. For example, a tubular structure 4600 containing 336 warp threads woven in a plain weave will have a higher weave density than a tubular structure 4600 containing 168 warp threads in a plain weave configuration. Varying the weave density can also affect the weight of the tubular structure 4600. In some forms, a lightweight tubular structure 4600 may be desired so that a user is not adversely affected by the weight of the tubular structure 4600.
[0184] In some embodiments, the tubular structure 4600 may be formed to a specific length to reduce weight. In some embodiments, a portion or the entire tubular structure 4600 may be 2 meters long. A 2-meter tubular structure 4600 may have a variety of weights depending on the material selected and the density of the warp and weft yarns, among other factors. In some embodiments, the 2-meter tubular structure 4600 may be formed to weigh 100 grams or less. In some embodiments, the 2-meter tubular structure 4600 is configured to weigh 75 grams or less. In a further embodiment, the 2-meter tubular structure 4600 weighs approximately 64 grams. In a further embodiment, the 2-meter tubular structure 4600 weighs less than 64 grams. Additionally, in other embodiments, the 2-meter tubular structure 4600 may weigh more than 100 grams.
[0185] The number of warp yarns in the tubular structure 4600 can also affect the flexibility of the tubular structure 4600. Flexibility can include the ability of the tubular structure 4600 to stretch longitudinally (see FIG. 18) and the ability of the tubular structure 4600 to expand when exposed to pressurized air from within the tubular structure 4600. In addition, flexibility can refer to the ability of the tubular structure 4600 to contract when exposed to pressure or force external to the tubular structure 4600. Flexibility also includes the ability of the tubular structure 4600 to bend relative to an axis through the center of the tubular structure 4600 (see FIG. 17).
[0186] Increasing the number of warp threads of a given material in the tubular structure 4600 may decrease longitudinal flexibility. Conversely, decreasing the number of warp threads of a material may increase longitudinal flexibility compared to a tubular structure 4600 that includes more warp threads.
[0187] Also, a tube with a high warp count may not radially expand to the same extent as a tube with a low warp count. The higher the warp density of a given material, the less the tube may be able to radially expand. The number of warp threads may be selected to allow or limit expansion depending on the desired properties of the air circuit 4170.
[0188] Additionally, a tubular structure with a higher number of warp threads may not bend as easily as a tubular structure with a lower number of warp threads. In some embodiments, a lower amount of force may be required to bend a tubular structure 4600 that includes a lower number of warp threads. Furthermore, in some embodiments, a tubular structure 4600 with a lower number of warp threads, such as 168, may kink more easily than a tubular structure 4600 with a higher number of warp threads. Therefore, having too few warp threads may increase the likelihood of accidental blockage due to bending of the tubular structure 4600.
[0189] A tubular structure with a higher warp thread count may have a larger radius of curvature when bent compared to a tubular structure with a lower warp thread count (see, e.g., FIG. 29). A patient may desire multiple orientations of the air circuit 4170 for comfort. In some configurations, the patient may desire to bend or deform the tubular structure 4600 to achieve these various orientations to comfortably utilize the treatment device. The ability of the tubular structure 4600 to bend through a smaller radius of curvature may allow the patient to fine-tune the air circuit 4170 for comfort. Therefore, a balance may be achieved between too few warp threads, which causes the tubular structure 4600 to twist, and too many warp threads, which only allows the tubular structure 4600 to bend through a large arc. The number of warp threads that may be utilized to achieve this result may depend on the type of thread material and the thickness of the thread utilized for the warp. For example, a fewer number of stretch-resistant warp yarns may be utilized to form a particular tubular structure 4600 compared to flexible warp yarns.
[0190] In one embodiment, the warp yarns can be multifilament or monofilament yarns. In one embodiment, the warp yarns can include a core material wrapped with other fibers. The use of a core yarn can allow the warp yarns to combine the characteristics of both a core material and a fiber in one yarn. In some embodiments, the warp yarns incorporate a Lycra® core having a specific decitex. In some embodiments, the core can be 156 decitex. In other embodiments, the core can be 1880 decitex. In further embodiments, the core can be 156 to 1880 decitex. In other embodiments, the core can be less than 156 decitex or greater than 1880 decitex. The coating of the warp yarns can have different properties than the core. In some embodiments, the coating can be 76 decitex. In other embodiments, the coating can be 110 decitex. The coating and core can be varied depending on the properties used in the warp direction. Other decitex numbers, for example, 150, 250, 350, 450, 550, as well as ranges between the listed decitex numbers, may be utilized in the yarn as a core or coat for a particular yarn in the warp or weft direction.
[0191] The particular yarns used in the warp threads can affect the stretchability and stability of the tubular structure 4600. Using a stretchable material can allow the tubular structure 4600 to stretch; however, a material that is too stretchable may require an increased number of warp threads to form a stable structure. Additionally, varying the stretchability of the warp material may allow for more or fewer warp threads to be utilized during manufacture.
[0192] 5.5.3.3 Weft There are a variety of weft yarn configurations and arrangements that can be utilized. In some configurations, the tubular structure 4600 can be formed using a circular loom including six shuttles, as depicted in Figures 12 and 13. In other configurations, circular looms with more or less than six shuttles can be utilized. As described in this specification, a circular loom with six shuttles is utilized.
[0193] As described with reference to Figures 12 and 13, each shuttle may be fitted with a bobbin containing linear elements such as threads or strands. The shuttles are configured to move in a circular motion such that the threads disposed on the bobbins within each shuttle are woven between the warp threads, thereby forming a circular tubular object containing the warp and weft threads.
[0194] As such, the weft yarns spiral along the length of the tubular object and combine with the warp yarns to form a tubular structure. A variety of material types, material densities, and configurations of weft yarns can be utilized to form particularly comfortable and useful tubes for use in respiratory devices.
[0195] The weft yarns can be made of a variety of materials. In some embodiments, the weft yarns can be made of natural or synthetic materials. For example, in some embodiments, the weft yarns can be made of cotton, wool, or silk. In other embodiments, the weft yarns can be made of elastane, rayon, polyester ("PES"), polyurethane, plastic, polyamide ("PA"), or other synthetic materials. The weft yarns can also be a combination of different materials. For example, in some embodiments, the weft yarns can be made of a combination of synthetic and natural materials. In some embodiments, the yarns can be made of a combination of synthetic and natural materials. In other embodiments, each yarn can be made entirely of natural or synthetic materials, but natural and synthetic yarns can be used to form the tubular structure. In yet other embodiments, the yarns can be made of a combination of different natural or synthetic materials. For example, a particular yarn can be made of both cotton and wool. In addition, a particular yarn can be made of polyester and elastane. Additionally, threads made of specific materials may be used to form the tubular structure. For example, one thread may be made of polyester, while a second thread may be made of elastane. These various threads may be utilized to enhance or degrade specific properties of the tubular structure. For example, certain materials may be utilized to enhance comfort, while other materials may be utilized to enhance the stretchability of the tubular structure. Any combination of thread configurations and thread types may be utilized in any one or all of the bobbins on the shuttle 4702.
[0196] In some configurations, these weft yarns may be monofilament or multifilament yarns, and the particular yarn may be selected to obtain particular properties, such as stretch resistance or comfort. In some configurations, a combination of monofilament and multifilament yarns may be utilized in a particular tubular structure.
[0197] In some configurations, the weft yarns may be knitted together to achieve a particular structure or to take advantage of specific properties of the weft yarns. In some configurations, multiple weft yarns may be used in conjunction with one another to achieve specific stretch and structural properties between each weft yarn while forming a particular structure. Some weft yarns may be used specifically to provide a structure that prevents the tubular structure from clogging during use. These weft yarns may also be used to support the tubular structure to reduce the likelihood of clogging and to resist clogging due to external forces. Additionally, these weft yarns may be used to ensure the flexibility and stretchability of the tubular structure.
[0198] In some embodiments, the weft density of the tubular structure can be varied depending on the desired properties of the tubular structure. The weft density can also affect the ability of the tubular structure to be formed on a machine. For example, if the weft density is too low, the machine may malfunction during the formation of the tube. Similarly, if the weft density is too high, the circular loom may malfunction during the formation of the tubular structure. Therefore, a particular weft density should be selected to allow the tubular structure to be formed on the loom.
[0199] The weft density can affect the flexibility and stability of the tubular structure. A high weft density can increase the stability of the tubular structure but decrease its flexibility. Similarly, a low weft density can increase the flexibility of the tubular structure but decrease the stability of the structure. The term stability is used to refer to the ability of a tubular structure to retain and maintain its shape and to consistently return to a particular shape after being subjected to a particular force. For example, a high weft density structure can have a particular shape and deform slightly when pressed or compressed. When the force is removed, the high weft density structure can return to its original shape. In contrast, a low weft density structure may not initially have a clearly defined tubular structure. A low weft density structure may compress or shrink more than a high weft density structure. When the force is removed from a low weft density structure, it may not return to its original shape or may take longer to return to its original shape. In some embodiments, it may be desirable to have a flexible yet stable tubular structure. Thus, the weft density can be between a high and a low weft density. In some embodiments, the weft density can be between 10 and 100 threads / cm. In some embodiments, the weft density can be between 20 and 45 threads / cm. In further embodiments, the weft density can be between 30 and 75 threads / cm. In other embodiments, the weft density can be between 60 and 100 threads / cm. In some embodiments, the weft density can be about 30 threads per 10 cm. In other embodiments, the weft density can be about 40 threads per 10 cm. In further embodiments, the weft density can be about 50 threads per 10 cm.
[0200] 30-32, schematic diagrams of portions of a tubular structure 4600 having various weft thread densities are depicted. In FIG. 30, the tubular structure 4600 has a weft thread density of approximately 50 threads per 10 cm. In FIG. 31, the tubular structure 4600 has a weft thread density of approximately 40 threads per 10 cm. In FIG. 32, the tubular structure 4600 has a weft thread density of approximately 30 threads per 10 cm. As shown, the spacing between each weft thread varies depending on the weft thread density. As discussed with reference to FIG. 17, varying the position of the weft threads can affect the bendability of the tubular structure 4600. For example, a higher weft thread density will likely reduce the ability of the tubular structure 4600 to bend significantly. Because the ridges 4618 are positioned closer together, they will abut against each other when bent slightly compared to ridges 4618 that are widely spaced apart.
[0201] Additionally, changing the weft yarn density also changes the angle between the weft yarns 4606 and the warp yarns 4604. Changing the angle between the weft yarns 4606 and the warp yarns 4604 can affect the occlusion resistance of the tubular structure 4600. When the weft yarns 4606 are spaced farther apart, the weft yarns 4606 have less ability to resist shape changes, in part because there is less mass or material available in a particular location to resist force. Therefore, utilizing a weft yarn density that is too low increases the likelihood of the tubular structure 4600 occluding.
[0202] The warp and weft materials may be selected individually and in conjunction with the tubular structure based on their physical properties as well as their visual appearance. In some configurations, a woven or fabric-like appearance may be desired. In such cases, a material such as Core Lycra® 156 dtex coated PES dtex 76f24x1 may be utilized in the warp direction. This material may allow a matte finish to be placed along the tubular structure rather than a glossy finish. Patients may prefer the visual aesthetics of a matte or flat material. Furthermore, the feel of the material may be pleasant to the patient. This contrasts with other tubular structures that may be formed using silicone or plastic materials along the exterior surface. Orienting a fibrous material along the exterior surface of the tubular structure may allow the patient to experience a softer feel of the material compared to a hard or cold plastic or silicone.
[0203] Additionally, the physical properties may affect how the tubular structure looks in other ways. For example, the tubular structure may be specifically formed so that the tubular surface is consistent or constant along the length of the tubular structure. For example, the tubular structure may have grooves and ridges. If the grooves or ridges do not have a consistent height or width, the patient may assume that the tubular structure was not created correctly or that the tubular structure will not function properly. Therefore, maintaining a particular shape of the tubular structure increases the likelihood that the patient will continue to receive treatment with the device.
[0204] In some embodiments, materials of various diameters may be used to form the tubular structure. Varying the yarn diameter may alter the overall appearance of the tubular structure. Furthermore, varying the yarn diameter may affect the physical properties of the tubular structure. For example, in some embodiments, monofilament weft yarns with a diameter of approximately 0.7 mm may be used. In other embodiments, monofilaments with a diameter of 0.5 to 0.9 mm may be used. In some embodiments, the monofilament yarns may have diameters greater than 0.9 mm or less than 0.5 mm. The monofilament yarns may help maintain the circular structure of the tubular structure and may help provide a particular concertina shape to the tubular structure. In other embodiments, monofilaments with a diameter of approximately 0.8 mm may be used. Monofilaments with a diameter of 0.8 mm may exhibit greater deviation or deviation from the centerline of the tubular structure. That is, the ridges or peaks of a concertina-shaped tubular structure may be higher than the ridges or peaks of a tubular structure formed using a monofilament structure with a diameter of 0.7 mm. In some configurations, patients may prefer a tubular structure that is lower profile or has less deviation from the baseline centerline, and a lower profile may be less irritating to the user due to the greater consistency of the shape of the tubular structure using 0.7 mm monofilament.
[0205] The monofilament can function as a helical coil used to support the tubular structure. This helical coil can be used to resist occlusion or compression due to forces perpendicular to the monofilament. Additionally, in some configurations, the monofilament can be surrounded by a woven material via the warp. This separates the monofilament from the user's skin, protecting it from the exterior of the tubular structure. Separating the monofilament from the exterior reduces the likelihood that the patient will feel it.
[0206] 5.5.3.4 Tubular structure configuration Referring to Figures 19-24, Table 4632 in Figure 25 and Table 4634 in Figure 26 illustrate various weft yarn orientations within a tubular structure. These figures illustrate various weft yarn orientations within a tubular structure. While the warp yarn construction can vary, for purposes of illustration, it will be constructed from 252 yarns, with the yarns being a core Lycra® 156 dtex and a coated PES 76f24x1 dtex. As previously mentioned, various materials may be utilized in the warp direction. Furthermore, various amounts of yarns may be utilized in the warp direction. That is, more or less than 252 warp yarns may be utilized to form the tubular structure. These warp and weft yarns are constructed in a plain weave. Again, as previously mentioned, other constructions, such as basket weaves and leno weaves, may also be utilized. Additionally, each tubular structure in Figures 19-24 has an outer diameter of 18 millimeters. As previously mentioned, the diameter of each tubular structure can vary, for example, between 15 and 30 millimeters. For purposes of illustration, however, we will assume that each tubular structure has a maximum outer diameter of 18 millimeters. That is, due to the ribbed nature of the tubular structure, the outer diameter of the ridges is approximately 18 millimeters. While the various configurations shown in Figures 19-24 are formed using the same warp yarns and warp densities, it should be recognized that various warp yarns and warp densities can be utilized, as well as various weaves other than plain weave configurations. The weft yarn structure can include various repeats of material oriented in a specific manner. These yarns assist in forming the lenticular or ribbed structure of the tubular structure. As previously mentioned, various amounts of warp yarns can be utilized in the tubular structure, and tubular structures of various diameters can also be formed.
[0207] Referring to Table 4632, various materials are associated with yarn numbers for ease of description regarding various configurations of tubular structures. These yarn numbers are utilized to indicate the orientation of the yarns within the tubular structures of Figures 19-24. In Table 4632, Yarn No. 1 is a PA monofilament having a diameter of 0.7 mm. Yarn No. 2 is a PA 6.6 Z150 having 880 dtex. Yarn No. 3 is a PA 6.6 Z300 having 440 dtex. Yarn No. 4 has a Lycra® core of 1880 dtex and a PEX textured coat of 110 f36 x 1 dtex. Yarn No. 5 is a PA monofilament having a diameter of 0.8 mm. Yarn No. 6 has a Lycra® core of 156 dtex and a PEX textured coat of 76 f24 x 1 dtex. Each of these materials may be selected for properties such as stretch and rebound, as well as other properties such as tactile feel. Furthermore, each yarn may be substituted for or swapped out for another yarn to achieve specific properties within the tubular structure. While Table 4632 lists possible material types, it is not exhaustive and many other yarn types and diameters may be used to form the tubular structure.
[0208] Table 4634 shows the orientation of the weft yarns within each tubular structure. This table illustrates the shuttles within the circular loom 4700 shown in FIG. 12. Shuttles 1 through 6 (first shuttle 4710 through sixth shuttle 4715) rotate in a circular path, depositing weft yarns to be woven with the warp yarns. As the shuttles deposit yarns, the warp yarns move vertically (e.g., out of the page of FIG. 12). This creates a "spiral" effect of the weft yarns within the tubular structure. Furthermore, because the shuttles are arranged on a circular track, it should be recognized that the yarns of shuttle 6 (e.g., sixth shuttle 4715) may be positioned adjacent to the yarns of shuttle 1 (e.g., first shuttle 4710) when assembled into a tubular structure. The orientation of the weft yarns within the tubular structure may then be repeated until the desired amount of tubular structure is formed. As yarns are deposited into the tubular structure, the shuttles deposit the yarns at specific locations. For example, the first shuttle 4710 deposits a yarn at a first weft location that will be adjacent to the yarn deposited at the second weft location by the second shuttle 4711. In some embodiments, multiple weft locations may be referred to as a weft section. For example, a weft section may include weft yarns deposited by the third shuttle 4712 through the sixth shuttle 4715. In other embodiments, a weft section may refer to a single weft location. For example, a weft section may include yarns deposited only from the third shuttle 4712, and therefore the weft location and the weft section may be the same. Within the description of a weft section, each weft location may be referred to as a weft section position.
[0209] 19, a schematic diagram of a portion of a particular configuration of a tubular structure is shown along with a weft yarn arrangement 4635. As shown, the particular yarn arrangement set forth in Table 4634 is utilized. In the configuration of weft yarn arrangement 4635, the first shuttle position utilizes yarn number 1. The second shuttle position utilizes yarn number 2. The third shuttle position utilizes yarn number 3. The fourth shuttle position utilizes yarn number 4. The fifth shuttle position utilizes yarn number 3. The sixth shuttle position utilizes yarn number 2.
[0210] Yarn No. 1 supports the tubular structure so that it resists closure when compressed. Yarn No. 1 may generally be stronger and stiffer than other materials. That is, Yarn No. 1 may have higher tensile strength and / or stretch resistance. Additionally, in some configurations, Yarn No. 1 may have a larger diameter, which may help further support the tubular structure to keep it open even when pressurized air is not passing through the yarn arrangement 4635. Yarn No. 2 may be deposited adjacent to Yarn No. 1 within the weft arrangement 4635 of the tubular structure. When weft yarns are referred to as being adjacent to one another, it is assumed that there is a warp yarn between the adjacent yarns unless otherwise specified, as previously described. Yarn No. 2 may help support the tubular structure. Adjacent to Yarn No. 2 is Yarn No. 3. Yarn No. 3 may be lighter than Yarn No. 2 because its decitex number is lower than that of Yarn No. 2, but Yarn No. 3 may be formed of polyamide. Adjacent to Yarn No. 3 is Yarn No. 4. Yarn No. 4 contains a Lycra® core to help ensure stretch and is coated with polyester to increase the stability of Yarn No. 4. Yarn No. 4 allows weft yarn arrangement 4635 of the tubular structure to stretch while maintaining the stability of the tubular structure. Yarn No. 4 is next to Yarn No. 3, followed by Yarn No. 2, and so on, repeating the pattern before starting again with Yarn No. 1. This repeating pattern provides a uniform, continuous look and feel for the tubular structure with weft yarn arrangement 4635 while providing measurable stretch along the length of the tubular structure including weft yarn arrangement 4635.
[0211] In addition to including weft yarn arrangement 4635, Figure 19 also includes the orientation of warp yarns 4604 relative to the weft yarns of weft yarn arrangement 4635. As previously described, warp yarns 4604 extend above and below adjacent weft yarns along the length of the tubular structure. In this manner, these weft yarns are bound by the warp yarns on either side of them. Such configurations may exist in tubular structures that include weft yarn arrangements such as those depicted in Figures 19-24, although for clarity, weft yarns are not shown in all of Figures 19-24.
[0212] Referring now to FIG. 20, weft yarn arrangement 4637 is depicted. A cutaway section of tubular structure 4600 including weft yarn arrangement 4637 illustrates the orientation of weft yarns within a portion of weft yarn arrangement 4637 and within tubular structure 4600. Additionally, for clarity, only a portion of tubular structure 4600 is depicted with warp yarns 4604. It should be appreciated that tubular structure 4600 of FIG. 20 and other tubular structures including the weft yarn arrangement depicted in FIGS. 19-24 also include warp yarns 4604 that bind each of the yarns of weft yarn 4606. As shown, the specific material arrangements set forth in Table 4634 are utilized. In the configuration of FIG. 20, thread number 1 is utilized in the first shuttle position. Thread number 5 is utilized in the second shuttle position. Thread number 2 is utilized in the third shuttle position. Thread number 4 is utilized in the fourth shuttle position. The fifth shuttle position utilizes thread number 4. The sixth shuttle position utilizes thread number 3.
[0213] In this configuration, two monofilaments are used adjacent to each other. This configuration may increase the stability of weft arrangement 4637 compared to weft arrangement 4635. The inclusion of two adjacent monofilaments having diameters of 0.7 mm and 0.8 mm may create a choke-resistant ridge. This ridge may be stronger than any ridge created with weft arrangement 4635 due to the doubled-up large PA monofilament. The inclusion of a large monofilament in thread number 5 may increase strength and choke resistance compared to weft arrangement 4635.
[0214] Additionally, adjacent to Yarn No. 5 is Yarn No. 2, which has a higher decitex value. This yarn orientation may allow for a gradual transition from a thicker, stronger monofilament strand to a more extensible material, such as Yarn No. 4. Similarly, Yarn No. 3 is adjacent to Yarn No. 1, allowing for a gradual transition to the thicker, stronger monofilament strand of Yarn No. 1. Disposed between Yarn No. 2 and Yarn No. 3 are two separate yarns of Yarn No. 4. These two yarns are positioned adjacent to each other so that the warp yarn passes between Yarn No. 4 coming from the fourth shuttle position and Yarn No. 4 coming from the fifth shuttle position. By orienting two yarns of Yarn No. 4 adjacent to each other, the extensibility of the tubular structure-integrated weft yarn arrangement 4637 may be pronounced in the region containing two Yarn No. 4 yarns. Additionally, a valley or groove may be formed in the region of the weft yarn arrangement 4637 containing two adjacent Yarn No. 4 yarns.
[0215] The two adjacent yarns of yarn number 4 may also provide stability during bending of weft yarn configuration 4637. Due to the fact that weft yarn configuration 4637 has two adjacent monofilament strands, when a tubular structure having weft yarn configuration 4637 is bent, the monofilament strands may be less likely to change shape or distort when subjected to an external force. This force may also be transferred to the adjacent yarn. In some configurations where a weaker yarn, such as yarn number 6, is used instead of yarn number 4, a tubular structure having weft yarn configuration 4637 may deform when bent. Utilizing a stronger elastane yarn, such as yarn number 4, reduces the likelihood of deformation when a tubular structure having weft yarn configuration 4637 is bent. Additionally, utilizing yarn number 4 in certain locations may result in a smoother curve when a tubular structure having weft yarn configuration 4637 is bent, as yarn number 4 helps maintain a stable and consistent structure.
[0216] As shown in FIG. 20 , the outer surface of the tubular structure 4600 can be affected by the size and shape of the weft yarns in the weft yarn arrangement 4637. While yarn size can affect the shape of the tubular structure 4600, the depiction in FIG. 20 has been exaggerated and enlarged for illustrative purposes. For example, a ribbed structure can result not only from differences in weft yarn size but also from the orientation of the weft yarns. Additionally, as shown in FIGS. 19-24 , the inner surfaces of the weft yarns are generally parallel to one another. In some configurations, such as that shown in FIG. 16 , when the tubular structure has a ribbed configuration, the inner surfaces of the weft yarns can be positioned in different longitudinal planes compared to adjacent weft yarns. The configurations depicted in FIGS. 19-24 are utilized to illustrate various iterations of yarn configurations within the tubular structure.
[0217] Referring now to Figure 21, a schematic diagram of a weft yarn arrangement 4639 is depicted. As shown, the specific material arrangement set forth in Table 4634 is utilized. In the configuration of Figure 21, thread number 1 is utilized in the first shuttle position. Thread number 1 is also utilized in the second shuttle position. Thread number 2 is utilized in the third shuttle position. Thread number 4 is utilized in the fourth shuttle position. Thread number 4 is utilized in the fifth shuttle position. Thread number 3 is utilized in the sixth shuttle position.
[0218] This yarn orientation is similar to that of weft yarn arrangement 4637. However, in weft yarn arrangement 4639, rather than including yarn No. 1 adjacent to yarn No. 5, weft yarn arrangement 4639 includes two adjacent yarns No. 1. In this manner, a consistent shape is created in the tubular structure of weft yarn arrangement 4639. The orientation of two monofilament yarns next to each other may help maintain a stable structure while also ensuring flexibility of the tubular structure having weft yarn arrangement 4639. Furthermore, utilizing monofilaments of the same size may result in a uniform appearance of the tubular structure. Additionally, using the same monofilaments may reduce costs compared to other tubular structures that use multiple monofilaments of different sizes.
[0219] Additionally, a weft pattern can include a variety of weft yarns. A weft pattern can be a pattern that repeats throughout the tubular structure. The starting point of the pattern determines how the pattern is described. As shown in FIG. 21 , weft yarn arrangement 4639 includes a pattern of weft yarns that repeats along the length of the tubular structure that includes weft yarn arrangement 4639. This is due to the placement of shuttle 4702 within loom 4700. Because shuttle 4702 is positioned in a track, the weft yarn placement is consistent along the length of the tubular structure. Weft yarn arrangement 4639 includes weft pattern 4669. This weft pattern includes a thread number 1 yarn adjacent to a thread number 2 yarn. Thread number 2 yarn is adjacent to a thread number 4 yarn. Thread number 4 yarn is adjacent to another thread number 4 yarn. A second thread number 4 yarn is adjacent to a thread number 3 yarn. Thread number 3 yarn is adjacent to a thread number 1 yarn. This yarn pattern is repeated along the length of the tubular structure. In this example, weft yarn pattern 4669 may begin with the yarn deposited by second shuttle 4711. As previously mentioned, various other patterns or pattern subsets may also be included.
[0220] Referring now to Figure 22, a schematic diagram of a portion of weft yarn configuration 4641 is depicted. As shown, the specific material configuration set forth in Table 4634 is utilized. In the configuration of Figure 22, thread number 5 is utilized in the first shuttle position. Thread number 5 is also utilized in the second shuttle position. Thread number 2 is utilized in the third shuttle position. Thread number 4 is utilized in the fourth shuttle position. Thread number 4 is utilized in the fifth shuttle position. Thread number 3 is utilized in the sixth shuttle position.
[0221] The configuration of weft yarn arrangement 4641 is similar to that of weft yarn arrangement 4637, except that in weft yarn arrangement 4637, two of the yarns number 5 are positioned adjacent to one another. A tubular structure having weft yarn arrangement 4641 may have superior stability and occlusion resistance compared to tubular structures having weft yarn arrangement 4639 and weft yarn arrangement 4637 due to the double inclusion of yarn number 5. However, in some embodiments, a tubular structure having weft yarn arrangement 4641 may not be as flexible as a tubular structure having either weft yarn arrangement 4637 or weft yarn arrangement 4639 for the same reasons. Additionally, in some embodiments, the large size of the monofilament of yarn number 5 may make it difficult to manufacture. In some embodiments, the large size of multiple monofilament strands may twist during manufacturing and cause loom malfunctions, resulting in an inconsistent weave and a tubular structure with a non-uniform appearance.
[0222] As shown in FIG. 22 , weft yarn arrangement 4641 includes a pattern of weft yarns that repeats along the length of the tubular structure that includes weft yarn arrangement 4641. This is due to the location of shuttle 4702 within loom 4700. Because shuttle 4702 is located in a track, the weft yarn arrangement is consistent along the length of the tubular structure. Weft yarn arrangement 4641 includes weft pattern 4671. This weft pattern includes a thread number 5 yarn adjacent to thread number 5. A second thread number 5 yarn is adjacent to a thread number 2 yarn. The thread number 2 yarn is adjacent to a thread number 4 yarn. The thread number 4 yarn is adjacent to another thread number 4 yarn. The second thread number 4 yarn is adjacent to a thread number 3 yarn. This thread pattern repeats along the length of the tubular structure. In this example, weft yarn pattern 4671 may begin with the yarn deposited by first shuttle 4710. As previously mentioned, various other patterns or pattern subsets may be included. Therefore, the pattern begins at a different shuttle position than weft pattern 4669 shown in FIG. 21 . Other patterns are contemplated, including two-yarn repeats, three-yarn repeats, and so on. Additionally, the "start" and "end" of a pattern may be redefined. For example, a six-yarn pattern may be divided into two three-yarn repeats. These pattern arrangements may be useful in understanding the material and quantities required to form a specific number of tubular structures during their manufacture.
[0223] Referring now to Figure 23, a schematic diagram of a portion of a weft yarn arrangement 4643 is depicted. As shown, the specific material arrangement set forth in Table 4634 is utilized. In the configuration of Figure 23, thread number 1 is utilized in the first shuttle position. Thread number 1 is also utilized in the second shuttle position. Thread number 6 is utilized in the third shuttle position. Thread number 4 is utilized in the fourth shuttle position. Thread number 4 is utilized in the fifth shuttle position. Thread number 6 is utilized in the sixth shuttle position.
[0224] The construction of weft yarn arrangement 4643 is similar to other weft arrangements, but includes some differences. Weft yarn arrangement 4643 is similar to weft yarn arrangement 4639 in that weft yarn arrangement 4643 includes two adjacent yarns designated Yarn No. 1. However, adjacent to each of these Yarn No. 1 yarns is a yarn designated Yarn No. 6. This yarn may have a lower decitex count and a different construction than either Yarn No. 2 or Yarn No. 3 utilized in weft arrangement 4639. Additionally, this yarn may be the same yarn type as that used in the warp direction of weft yarn arrangement 4643. Utilizing Yarn No. 6 may enhance the appearance and feel of the fabric or texture imparted to a tubular structure including weft yarn arrangement 4643, as compared to other configurations. This may be appreciated by patients, who may find the appearance of the fabric or texture more comfortable, thereby increasing the likelihood of continued use of a treatment device including weft yarn arrangement 4643. Additionally, Yarn No. 6 may be more flexible than other yarns, such as Yarn No. 2 and Yarn No. 3, utilized in other configurations. Utilizing thread number 6 may allow weft thread arrangement 4643 to be more flexible than other configurations, while maintaining the structural integrity of the tubular structure through the use of thread number 1. Thread number 1 may provide a helical coil to the tubular structure.
[0225] Additionally, the weft arrangement 4643 is configured with fewer different threads than previous configurations. By configuring the weft arrangement 4643 with fewer different threads, the weft arrangement 4643 may be less expensive to construct compared to other tubular structures that include a larger number of different threads.
[0226] In addition to being less expensive than tubular structures including weft yarn arrangements with many different weft yarns, weft yarn arrangement 4643 may be specifically configured to provide a consistent, uniform structure. This uniform structure may assist in providing an exterior surface that is acceptable to consumers. That is, because the pattern is "symmetrical" across an imaginary line between the two No. 4 yarns, tubular structures constructed with such a weft yarn arrangement may have a particularly uniform appearance.
[0227] Referring now to Figure 24, a schematic diagram of a portion of a weft yarn arrangement 4645 is depicted. As shown, the specific material arrangement set forth in Table 4634 is utilized. In the configuration of Figure 24, in the first shuttle position, thread number 1 is utilized. In the second shuttle position, thread number 5 is utilized. In the third shuttle position, thread number 6 is utilized. In the fourth shuttle position, thread number 4 is utilized. In the fifth shuttle position, thread number 4 is utilized. In the sixth shuttle position, thread number 6 is utilized.
[0228] The configuration of weft arrangement 4645 is similar to the configuration of weft arrangement 4643. However, weft arrangement 4645 includes thread number 1 in the first shuttle position and thread number 5 in the second shuttle position. The configuration of weft arrangement 4645 may be more stable than the configuration of weft arrangement 4643 while maintaining flexibility and bendability. However, utilizing two monofilament threads of different sizes in the first shuttle position and the second shuttle position may affect the outer shape of weft arrangement 4645. For example, the different sized monofilaments may provide a non-uniform shape to the outer surface of weft arrangement 4645. This may provide a particular texture to the outer surface. In some embodiments, this texture may vary depending on the shape and size of the weft yarns within the tubular structure. For example, as shown in FIG. 20 , the texture of tubular structure 4600 may be affected by the shape and size of the weft yarns.
[0229] In addition to providing particular strength and stretch properties, in some forms, the material utilized to form the tubular structure may be lightweight compared to other tubular structures that are not formed via a woven, braided, knitted, or other network of interlocking fibers. Additionally, the material utilized to form the tubular structure 4600 may be soft to the touch for comfort to the patient.
[0230] In some embodiments, a heating element may be included within the tubular structure 4600. The heating element may be utilized to provide heat to the air delivered to the patient. Additionally, in some embodiments, the heating element may support the tubular structure 4600. For example, monofilament material such as thread number 1 or thread number 5 may be replaced with conductive wires. These wires may be able to support the tubular structure 4600 while also providing an electrical conductive path for providing heat to the air circuit 4170 during use.
[0231] In some embodiments, a monofilament thread can be positioned adjacent to another monofilament thread. In some embodiments, a non-monofilament thread can be positioned between two monofilament threads. In some embodiments, the two monofilament threads can be different physical threads. In further embodiments, multiple non-monofilament threads can be positioned between the monofilament threads. The number of monofilament and non-monofilament threads can be adjusted based on the desired flexibility and strength of the tubular structure. In addition, the placement of a monofilament separated from other monofilaments by a multifilament can be achieved through various weft thread configurations. For example, in some embodiments, a weft thread pattern using all available shuttles can have a pattern including a monofilament separated from another monofilament by at least one non-monofilament thread. For example, the weft thread pattern 4669 described above has such a configuration.
[0232] In another embodiment, a tubular structure including monofilaments separated from other monofilaments by at least one non-monofilament can be achieved by repeating the pattern a second time. For example, the loom 4700 may include one monofilament weft yarn and five non-monofilament weft yarns on the shuttle 4702. When the tubular structure is formed, the first pattern formed includes one monofilament and five non-monofilament yarns. When the shuttle 4702 of the loom 4700 repeats the pattern a second time with a second revolution, the weft yarn configuration includes one monofilament, five non-monofilaments, one monofilament, and five non-monofilaments. In this manner, the monofilament yarns are separated from the monofilament yarns by five non-monofilament yarns. Thus, along the linear length of the tubular structure, the monofilaments are separated from the monofilaments by at least one non-monofilament yarn. The monofilament yarn in this configuration is the same monofilament yarn throughout the tubular structure, but the tubular structure may be considered to have the monofilament yarn spaced from the monofilament yarn by at least one non-monofilament yarn.
[0233] In some configurations, multiple monofilament yarns may be positioned adjacent to one another, as shown, for example, in FIG. 23. Utilizing two monofilament yarns adjacent to one another may increase the strength and resilience of a tubular structure including a weft yarn configuration, such as weft yarn configuration 4643, while minimizing the impact on the look and feel of the tubular structure. Weft yarn configuration 4643 includes two monofilament yarns rather than a single thick monofilament yarn. Utilizing two thin monofilament yarns may allow for the formation of a tubular structure with a smaller profile while maintaining strength and resilience within the tubular structure compared to a single thick monofilament yarn.
[0234] While specific weft yarn configurations and yarn configurations are discussed, other configurations are possible. The configurations presented are illustrative, providing some possible configurations. Each yarn may be interchangeable with another yarn. For example, instead of utilizing two adjacent yarns of Yarn No. 4 in weft configuration 4643, a yarn of Yarn No. 4 may be interchangeable with two yarns of Yarn No. 3. Furthermore, yarn configurations may be combined to create any combination of yarns. For example, a yarn of Yarn No. 5 may be adjacent to both a yarn of Yarn No. 4 and a yarn of Yarn No. 3. Any configuration and reconfiguration is possible. Furthermore, the specific yarns described are not intended to be exhaustive but rather to illustrate specific aspects of the present technology. A variety of yarns with various material constructions are contemplated, including polyester, polyamide, polyurethane, cotton, wool, and elastane. Also contemplated are yarns with various configurations, including coated and uncoated, cored and uncored, textured, crimped, Z-twisted, S-twisted, spun, and extruded. This list of materials is by no means exhaustive.
[0235] Each weft configuration may be formed with a variety of yarns. However, the yarn configuration and sequence may be modified or changed depending on the particular properties desired within the tubular structure and the air circuit incorporating the tubular structure. Weft configuration 4635 utilizes yarn numbers 1-4. Weft configuration 4637 utilizes yarn numbers 1-5. Weft configuration 4639 utilizes yarn numbers 1-4. Weft configuration 4639 utilizes the same yarn types as weft configuration 4635, but the arrangement and layout within weft configuration 4639 and weft configuration 4635 are different from each other. Weft configuration 4641 utilizes yarn numbers 2-5. Weft configuration 4643 utilizes yarn numbers 1, 4, and 6. Weft configuration 4645 utilizes yarn numbers 1, 4, 5, and 6. As shown, the yarn types and arrangement of specific yarns can be changed and interchanged to form any desired weft configuration.
[0236] Referring to FIG. 35, a selection matrix 4800 is depicted. The selection matrix 4800 is utilized to illustrate the various different yarn combinations that may be used to form a tubular structure or a weft placement or pattern within a tubular structure. The selection matrix 4800 includes shuttle position columns representing the various shuttles of the loom 4700. While six shuttles are described above, other looms having more or less than six shuttles may also be utilized. Additionally, as depicted in the selection matrix 4800, there are various yarn types that may be utilized on any one of the shuttles. As illustrated, each yarn may be selected ("Yes") or not selected ("No") to be loaded on any one or more of the shuttles. The selection of a particular yarn on any shuttle does not prohibit the selection of the same yarn on other shuttles. For example, yarn number 1 may be utilized on shuttle 1, shuttle 2, and shuttle 3. Thread No. 2 may be utilized in shuttle 4, shuttle 5, and shuttle 6. Additionally, thread No. 1 may be utilized in all or none of the shuttles. It should be recognized that any thread listed in selection matrix 4800 may be utilized in any one or more of the shuttles. Furthermore, multiple shuttles may have the same type of thread. In other configurations, the shuttles may all have different types of thread. In other configurations, any one of the shuttles may have any combination of threads. For example, a thread formed from thread No. 1 and thread No. 2 may be utilized in any one or more of the shuttles.
[0237] Each yarn may be selected for specific properties. For example, each yarn may be selected for a specific decitex, stretch, luster, softness, moisture absorption, tensile strength, hardness, softness, denier, diameter, appearance, and many other factors. These yarns may be selected for any one of the shuttles to impart any specific properties to the tubular structure. Furthermore, while specific yarns are listed in the selection matrix 4800, variations of any yarn or different yarns may be utilized. For example, monofilament yarns may be selected with different diameters or tensile strengths. Furthermore, yarns of various decitex numbers may be utilized that are not formed using the specific materials described herein. For example, yarn number 2 is 880 decitex PA 6.6 Z150. Other yarn types may also be utilized that are formed from different materials, such as polyurethane with an 880 decitex.
[0238] Additionally, the selection matrix 4800 may be applicable to a variety of warp yarns. That is, the warp yarns may be formed of any of the yarn types described herein, as well as a combination of one or more of the variations described. For example, half of the warp yarns may be yarn number 3 and the other half may be yarn number 6. The location of the warp yarns may be selected with similar precision to the location of the weft yarns. That is, every other warp yarn may be yarn number 3 and every other yarn may be yarn number 6. Thus, any one warp or weft yarn may be selected from the materials described herein. Additionally, the selection of a particular yarn does not preclude the selection of that yarn elsewhere in the tubular structure.
[0239] 5.5.3.5 Characteristics of tubular structures The tubular structure 4600 may be formed to allow the tubular structure to maintain its cross-sectional shape. In some embodiments, the tubular structure 4600 may be configured to maintain its shape even when subjected to an external force. As depicted in FIG. 10 , the air circuit 4170 containing the tubular structure 4600 may be able to change shape when subjected to a force, so that the tubular structure 4600 is not a rigid structure (see definition), but the air circuit 4170 can remain open to allow air to pass through. However, the tubular structure 4600 is not a flexible structure in at least one direction. The tubular structure 4600 may not be able to support its own weight along the weft direction. That is, unless further force is applied on or within the tubular structure 4600, the cross-section of the tubular structure 4600 along the weft direction remains open. In contrast, the tubular structure 4600 may be flexible (see definition) along its length. For example, if the tubular structure 4600 is held at one end along its length or weft direction, it may not be able to support its own weight and will bend. The amount of bending will depend on the length of the tubular structure 4600. For example, a longer tubular structure 4600 will bend more than a shorter one. However, even when bent, the tubular structure 4600 may remain open to allow air to pass through the tubular structure 4600.
[0240] In some embodiments, the tubular structure 4600 may be able to maintain its shape when subjected to a compressive force of 1 kilogram, which would tend to close the tubular structure. In other embodiments, the tubular structure 4600 may be able to maintain its shape when subjected to a force of 5 kilograms. In other embodiments, the tubular structure may be able to maintain its shape when subjected to a force between 1 kilogram and 5 kilograms. In yet other embodiments, the tubular structure 4600 may be able to maintain its shape when subjected to a force between 0 kilogram and 10 kilograms.
[0241] In some forms, the occlusion force may collapse the tubular structure 4600, thereby closing or significantly reducing the cross-sectional area of the tubular structure 4600. This may occur, for example, when a patient steps on the tubular structure 4600. When the force is removed, the tubular structure 4600 may return to its original shape, allowing air to move freely within the tubular structure 4600. In this manner, the tubular structure 4600 may be resilient (see definition).
[0242] Furthermore, the tubular structure 4600 may be capable of compressing longitudinally and maintaining its shape. In configurations in which the tubular structure 4600 includes a ribbed structure or the like, the valleys 4620 may compress with the ridges 4618 to shorten the overall length of the tubular structure 4600, while the tubular structure 4600 remains open to allow the passage of air through the tubular structure 4600 or an air circuit including the tubular structure 4600. In addition to being compressible longitudinally, the tubular structure 4600 may also be capable of expanding to an elongated state, as shown, for example, in FIG. 18 . During expansion, air may pass through the tubular structure 4600 or an air circuit including the tubular structure 4600.
[0243] 5.5.3.6 Air loss In some embodiments, the tubular structure may be constructed to have a specific leakage rate. In some embodiments, the leakage rate may be carefully selected or tested to determine whether post-treatment is necessary or desirable, and what type of post-treatment may be required or desirable. Additionally, in some embodiments, a specific leakage rate may be desired to remove waste air. In some embodiments, the leakage rate per meter of the tubular structure may be 300-2000 mL / min at 3 cmH2O pressure. In some embodiments, the leakage rate per meter of the tubular structure may be 500-2300 mL / min at 4 cmH2O pressure. In some embodiments, the leakage rate per meter of the tubular structure may be 700-2900 mL / min at 7 cmH2O pressure. In some embodiments, the leakage rate per meter of the tubular structure may be 900-3200 mL / min at 8 cmH2O pressure. In some embodiments, the tubular structure 4600 may have a leak rate per meter of approximately 1100 mL / min at a pressure of 3 cmH2O. In other embodiments, the leak rate per meter may be approximately 1380 mL / min at a pressure of 4 cmH2O. In other embodiments, the leak rate per meter may be approximately 1550 mL / min at a pressure of 5 cmH2O. In other embodiments, the leak rate per meter may be approximately 1650 mL / min at a pressure of 6 cmH2O. In other embodiments, the leak rate per meter may be approximately 1750 mL / min at a pressure of 7 cmH2O. In other embodiments, the leak rate per meter may be approximately 1820 mL / min at a pressure of 8 cmH2O. The leak rate may be used to determine the appropriate type of coating or coating technique to utilize for a particular tubular structure.
[0244] 5.5.4 Leak reduction In some forms, the tubular structure may be utilized in combination with an air therapy device in the form of an air circuit 4170. In some forms, a lower pressure leak rate may be desired so that the air circuit delivers air at a specific pressure to the patient at a consistent, specific therapeutic pressure. In some forms, the air circuit 4170 may be designed to provide air at a pressure of 4 cmH2O. In other forms, the air circuit 4170 may be designed to provide air at a pressure of 6 cmH2O. In further forms, the air circuit 4170 may be designed to provide air at a pressure of 8 cmH2O. In some forms, the air circuit 4170 is configured to have a leak rate of 2.5 mL / min per meter when the air circuit 4170 is delivering air at a therapeutic pressure. In other forms, the air circuit 4170 is configured to have a leak rate less than 2.5 mL / min per meter. In some forms, the air circuit 4170 is configured to have a non-zero leak rate. In some forms, providing a specific leak rate within the air circuit 4170 or other components utilizing the tubular structure 4600 and / or sealing structure 4650 may allow for the elimination of a separate vent.
[0245] In some embodiments, the tubular structure 4600 can be lined with a material configured to contain or retain air so that air does not leak through the tubular structure 4600 or leaks at a rate below a given threshold, such as 2.5 mL / min per meter or less. For example, as shown in FIG. 15 , the air circuit 4170 includes the tubular structure 4600 along with a sealing structure 4650. In some embodiments, the sealing structure 4650 can be formed from silicone or silicone rubber. In other embodiments, other sealing materials, such as acrylates, can be utilized. In still other embodiments, other materials, such as elastomeric materials, polyurethanes, thermoset materials, and / or thermoplastic materials, can be utilized. In other embodiments, the sealing structure 4650 can be formed from a biocompatible material. In yet another embodiment, the sealing structure 4650 can be formed from a soft, flexible, and resilient material.
[0246] In some configurations, the sealing structure 4650 can be formed such that it is a pre-formed tube, such as an extruded silicone tube. In such configurations, the tubular structure 4600 can be wrapped around the sealing structure 4650. In some configurations, the tubular structure 4600 can be woven over the sealing structure 4650, or the tubular structure 4600 can be braided or braided over itself. The tubular structure 4600 can be secured to the sealing structure 4650 by another material, such as an adhesive, between the tubular structure 4600 and the sealing structure 4650.
[0247] In some forms, this sealed structure may be formed after the formation of tubular structure 4600. In some forms, a liquid material may be sprayed onto the interior of tubular structure 4600. The sealed material may then be allowed to harden to form a solid sealed structure.
[0248] In other embodiments, a separate sealing structure may not be utilized. In some embodiments, the tubular structure 4600 may be pre-formed to provide a sufficient seal. In some embodiments, the tubular structure 4600 may be formed using an elastomeric material to resist water and / or air leakage. By forming the tubular structure 4600 from threads formed from certain materials, the weight of an air circuit utilizing the leakage-reducing tubular structure 4600 may be less than the weight of an air circuit utilizing the tubular structure 4600 with a separate sealing structure.
[0249] The thickness of the sealing structure can be varied to also vary the properties of the air circuit 4170. In some embodiments, the sealing structure 4650 can be 0.1 to 5 millimeters. In some embodiments, the sealing structure 4650 can be 0.25 to 4 millimeters. In yet other embodiments, the sealing structure 4650 can be 0.5 to 3.5 millimeters. In yet other embodiments, the sealing structure 4650 can be 1 to 4 millimeters. In some embodiments, the sealing structure 4650 can have a thickness of approximately 1 millimeter. In other embodiments, the sealing structure 4650 can have a thickness of approximately 0.65 millimeters. In yet other embodiments, the sealing structure 4650 can have a thickness of 0.55 to 0.6 millimeters. Varying the thickness of the sealing structure can affect the ability of the air circuit 4170 to flex or stretch. For example, a thicker sealing structure 4650 of a given material may stretch less than a thinner sealing structure 4650. Similarly, a thicker sealing structure 4650 may require more force to bend than a thinner sealing structure 4650. Therefore, changing the thickness of the sealing structure 4650 changes the physical properties of the sealing structure 4650.
[0250] The sealing structure 4650 may be secured to the tubular structure 4600 to form the tubular portion of the air circuit 4170. When secured to the tubular structure 4600, the sealing structure 4650 may affect the stretch and bending properties of the tubular structure 4600, as described above.
[0251] In some embodiments, the tubular structure 4600 may be secured to the sealing structure 4650 using a glue or other adhesive. In some embodiments, the adhesive may be air-dried, and in other embodiments, the adhesive may be set using ultraviolet ("UV") light or other devices. In still other embodiments, the sealing structure 4650 and the tubular structure 4600 may be joined without the use of an adhesive. In further embodiments, the sealing structure 4650 may be directly connected to the tubular structure 4600 solely through the material of the sealing structure 4650. For example, in some embodiments, the sealing structure 4650 may be applied to the tubular structure 4600 in liquid form. The sealing structure 4650 may dry and harden along with the tubular structure 4600, eliminating the need to use a separate material to join to the tubular structure 4600.
[0252] The strength of the sealing structure 4650 can also be varied to change or modify the properties of the air circuit 4170. The sealing structure 4650 can be formed using a material with a hardness of 15 to 75 Shore. In other embodiments, the sealing structure 4650 can be formed using a material with a hardness of 10 to 60 Shore. In further embodiments, the sealing structure 4650 can be formed using a material with a hardness of 25 to 50 Shore. In some embodiments, the sealing structure 4650 can be formed using 60 Shore silicone. In other embodiments, the sealing structure 4650 can be formed using 45 Shore silicone. In further embodiments, the sealing structure 4650 can be formed using 26 Shore silicone. In other embodiments, the sealing structure 4650 can be formed using silicone with a hardness of less than 26 Shore. Varying the hardness or strength of the sealing structure 4650 can affect the properties of the air circuit 4170. For example, a stiffer sealing structure 4650 may resist bending or occlusion to a greater extent than a softer sealing structure 4650. However, if the sealing structure 4650 is too stiff, it may kink when the air circuit 4170 is bent because a material that is too stiff cannot stretch or contract with the bend of the air circuit 4170, causing it to kink.
[0253] The hardness of the sealing structure 4650 can be selected or adjusted along with the thickness to achieve specific properties. For example, a sealing structure 4650 with a higher Shore number can be formed in a thinner configuration than a sealing structure 4650 with a lower Shore number. The thickness and Shore number can be varied depending on the desired termination properties of the air circuit 4170.
[0254] In some configurations, a sealing structure of a particular thickness and Shore hardness may be utilized. In one configuration, the sealing structure 4650 is 1 millimeter thick and 60 Shore. In another configuration, the sealing structure 4650 has a thickness of 0.65 millimeters and a 45 Shore. In yet another configuration, the sealing structure 4650 has a thickness of 0.55 to 0.6 millimeters and a 26 Shore. These various configurations may be utilized to achieve particular properties or functions of the air circuit 4170.
[0255] In addition to reducing air loss, the sealing structure may also assist in managing water within the air circuit 4170. In some forms, the sealing structure 4650 may be water resistant. During use of the treatment device, the air provided to the patient may be humidified. Additionally, gases exhaled by the patient may have a higher relative humidity than the ambient air. In some forms, during use, the humidified air may condense into water and line the air circuit 4170. The sealing structure 4650 may direct water to specific locations and prevent water from leaking through the tubular structure 4600.
[0256] 5.5.4.1 Weight of the enclosure In some forms, the air circuit 4170 can be formed with a sealing structure 4650 having a particular weight. In some forms, the sealing structure 4650 can be formed such that it imparts minimal weight to the air circuit 4170. The sealing structure 4650 can be designed to minimize or reduce its impact on the weight and flexibility of the air circuit 4170. For example, the sealing structure 4650 can be formed thin so that the extra or additional weight and material utilized in the air circuit 4170 is reduced or minimized.
[0257] In some embodiments, the sealing structure 4650 may be lighter than a tubular structure 4600 of the same or similar length. In some embodiments, a 2-meter tubular structure 4600 may weigh 25 grams to 100 grams. In other embodiments, the tubular structure 4600 may weigh 15 to 75 grams. In further embodiments, the tubular structure may weigh 30 to 60 grams. For example, in some embodiments, a 2-meter tubular structure 4600 may weigh approximately 64 grams. A corresponding length of the sealing structure 4650 may be formed along the inner surface of the tubular structure 4600. In some embodiments, the sealing structure 4650 may weigh 50 to 200 grams. In other embodiments, the sealing structure 4650 may weigh 75 to 125 grams. In further embodiments, the sealing structure 4650 may weigh 25 to 60 grams. In some embodiments, the sealing structure 4650 may weigh approximately 80 grams. In other embodiments, the sealing structure 4650 may weigh approximately 72 grams. In a further embodiment, the sealing structure 4650 may weigh 64 grams. In a further embodiment, the sealing structure 4650 may weigh 60 grams or even 40 grams or less. Thus, the sealing structure 4650 may weigh approximately 1.25 times the weight of the tubular structure 4600. The sealing structure 4650 may also weigh less than 1.25 times the weight of the tubular structure 4600. In some embodiments, the sealing structure 4650 may weigh 1.13 times the weight of the tubular structure 4600. In a further embodiment, the sealing structure 4650 may weigh approximately the same as the tubular structure 4600. In a further embodiment, the sealing structure 4650 may be lighter than the tubular structure 4600. For example, the weight of the sealing structure 4650 may be 94% of the weight of the tubular structure 4600. In a further embodiment, the weight of the sealing structure 4650 is 62% of the weight of the tubular structure 4600. In this manner, a lightweight air circuit 4170 may be formed that incorporates the tubular structure 4600 and the sealing structure 4650. In a further embodiment, the weight of the sealing structure 4650 may be between 62% and 1.25 times the weight of the tubular structure 4600.In further embodiments, the weight of the sealing structure 4650 may be more than 1.25 times the weight of the tubular structure 4600 or may be less than 62% of the weight of the tubular structure 4600. In some embodiments, the weight of the sealing structure 4650 may be 50%, 75%, or the same as the weight of the tubular structure 4600. In further embodiments, the weight of the sealing structure 4650 may be 25% to 90% of the weight of the tubular structure 4600. In further embodiments, the weight of the sealing structure 4650 may be 1 to 2 times the weight of the tubular structure 4600.
[0258] In some forms, the weight of the sealing structure 4650 can be affected by the thickness and material composition of the sealing structure 4650. As such, the weight of the sealing structure 4650 can be varied not only by changing the thickness of the sealing structure 4650, but also by changing the material composition of the sealing structure 4650.
[0259] 5.5.4.2 Closed structure configuration In some embodiments, the sealing structure 4650 may follow the contours of the tubular structure 4600. In some embodiments, as previously described, the tubular structure 4600 may have a ribbed shape, including peaks or ridges and valleys. Similarly, the sealing structure 4650 may include ridges and valleys. The inner surface of the tubular structure 4600 may include a ribbed surface including ridges and valleys. Referring to FIG. 33 , a portion of an air circuit 4170 is depicted that includes the tubular structure 4600 and the sealing structure 4650. As shown, the inner surface 4660 of the tubular structure 4600 includes ridges and valleys. The outer surface 4652 of the sealing structure 4650 corresponds to the inner surface 4660 of the tubular structure 4600 and follows the same or a similar path as the inner surface 4660 of the tubular structure 4600. That is, the outer surface 4652 of the sealing structure 4650 has an opposite curvature compared to the inner surface 4660 of the tubular structure 4600. For example, if the outer surface 4652 of the sealing structure 4650 has a positive curvature, the inner surface 4660 of the tubular structure 4600 has an opposite negative curvature.
[0260] Additionally, the inner surface 4654 of the sealing structure 4650 may mimic or relate to the inner surface 4660 of the tubular structure 4600. For example, the inner surface 4654 may have a positive curvature at the same or similar longitudinal position as the inner surface 4660 of the tubular structure 4600. In other forms, the inner surface 4654 may have a positive or negative curvature similar to that of the inner surface 4660 of the tubular structure 4600, but the magnitude of both the positive and negative curvatures may be smaller. The curvature of the inner surface 4654 may be less severe or gradual than the curvature of the inner surface 4660. The curvature of the inner surface 4654 may depend on the thickness of the sealing structure 4650. For example, a thicker sealing structure 4650 may have a less severe or gradual curvature compared to a thinner sealing structure 4650. The inner surface 4654 forms the boundary of a channel of the air circuit 4170 through which air is delivered to the patient. In this manner, the thickness and shape of the sealing structure 4650 determines the cross-sectional shape of the channel of the air circuit 4170. This channel or passage may be referred to as an open space formed or bounded by an interior surface, such as interior surface 4654.
[0261] Additionally, in some forms, the distance between the faces of the tubular structure 4600 and the sealing structure 4650 can be substantially constant along the length of the tubular structure 4600 and the sealing structure 4650. For example, as shown in FIG. 33 , the distance d1 from the inner surface 4660 to the inner surface 4654 of the sealing structure 4650 is substantially the same as the distance d2 from the inner surface 4660 to the inner surface 4654 of the sealing structure 4650. In this sense, the sealing structure 4650 can be aligned with the inner surface 4660 along the length of the tubular structure 4600 from rib to rib.
[0262] In other configurations, such as that shown in FIG. 34 , the sealing structure 4650 can be a freestanding structure to which the tubular structure 4600 is secured. For example, the sealing structure 4650 can be formed with a generally circular cross-section including an inner surface 4654 and an outer surface 4652 that have substantially zero curvature along the length of the sealing structure 4650. The tubular structure 4600 can be disposed around the sealing structure 4650, but gaps can occur between the ridges and valleys of the inner surface 4660 of the tubular structure 4600 and the outer surface 4652 of the sealing structure 4650 because the sealing structure 4650 may not be shaped to correspond to the shape of the tubular structure 4600. In configurations such as that depicted in FIG. 34 , the tubular structure 4600 can be secured to the sealing structure 4650 at contact points, such as points 4664, using an adhesive or other bonding mechanism. In other forms, the sealing structure 4650 may be heated to partially melt, allowing the fibers or strands or tubular structure 4600 to interact with the sealing structure 4650 to form a bond between the tubular structure 4600 and the sealing structure 4650. In other forms, the tubular structure 4600 may be constructed using a thermosetting or thermoplastic material such that components of the tubular structure 4600 partially melt and then harden to form a bond between the tubular structure 4600 and the sealing structure 4650.
[0263] Additionally, in some forms, the distance between the faces of the tubular structure 4600 and the sealing structure 4650 may vary along the length of the tubular structure 4600 and the sealing structure 4650. For example, as shown in FIG. 34 , the distance d3 from the inner surface 4660 to the inner surface 4654 of the sealing structure 4650 is different from the distance d4 from the inner surface 4660 to the inner surface 4654 of the sealing structure 4650.
[0264] In another configuration, the sealing structure 4650 can have a generally planar inner longitudinal surface 4654 and an outer surface 4652 that corresponds to the inner surface 4660 of the tubular structure 4600. Such a configuration would resemble a combination of the configurations depicted in Figures 33 and 34. In this manner, the material of the sealing structure 4650 can fill the spaces between the valleys of the tubular structure 4600.
[0265] In some embodiments, the inner diameter of the sealing structure 4650 can be carefully selected. In some embodiments, the innermost diameter of the sealing structure 4650 is between 10 and 25 millimeters. In some embodiments, the innermost diameter of the sealing structure 4650 is between 8 and 17 millimeters. In further embodiments, the innermost diameter of the sealing structure 4650 is between 11 and 20 millimeters. In some embodiments, the inner diameter of the sealing structure 4650 is approximately 14 millimeters. In other embodiments, the inner diameter of the sealing structure 4650 is 14.5 millimeters or 15 millimeters. In further embodiments, the inner diameter of the sealing structure 4650 is greater than 15 millimeters. In other embodiments, the inner diameter of the sealing structure 4650 is less than 14 millimeters. The inner diameter of the sealing structure 4650 can be affected not only by the thickness of the sealing structure 4650, but also by the inner diameter of the tubular structure 4600. The inner diameter can be varied to accommodate different amounts of air at different pressures used in conjunction with the RPT device 4000. This inner diameter may be finely sized to accommodate a volume of air at a particular pressure, for example, to maintain a particular pressure within the air circuit 4170 and against the patient.
[0266] The sealing structure 4650 may provide structural support to the tubular structure 4600 in addition to sealing the air circuit 4170. For example, the sealing structure 4650 may help provide support against forces that tend to occlude the air circuit 4170. However, the sealing structure 4650 may be able to compress and stretch without impeding the air path through the air circuit 4170. Further, the sealing structure 4650 may be able to stretch axially to at least twice its original length without tearing. Furthermore, when compressed, the sealing structure 4650 may be compressed evenly so as not to impede the air path through the air circuit 4170. Additionally, while the sealing structure 4650 may further support the tubular structure 4600, the air circuit 4170 including the sealing structure 4650 may be able to be packed into a coil or wound onto itself. This may allow the air circuit 4170, including the tubular structure 4600 and the sealing structure 4650, to be efficiently packed and stored when not in use.
[0267] 5.5.4.3 Other configurations of enclosed and tubular structures The tubular structure 4600 and the sealing structure 4650 may be utilized in other portions of the air treatment device in addition to the air circuit 4170. For example, the tubular structure 4600 and the sealing structure 4650 may be utilized as part of the patient interface 3000. The tubular structure 4600 may be used in various areas of the treatment device without the sealing structure 4650. For example, the tubular structure 4600 may be utilized to support various components rather than to transport air. For example, the tubular structure 4600 may form part of a strap. Additionally, in a further embodiment, the air circuit 4170 may connect to a tube formed from the tubular structure 4600 and the sealing structure 4650. Additionally, the tubular structure 4600 and the sealing structure 4650 may be utilized to form various portions of the patient interface 300, such as a sealing structure known as a shroud. Furthermore, the tubular structure 4600 may be used to encase or cover various components of the air treatment device.
[0268] 5.5.5 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.
[0269] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided (for example as shown in FIG. 5A) for changing the absolute humidity of air or gas to be delivered to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airways.
[0270] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.
[0271] 5.6.2 Humidifier Components 5.6.2.1 Water reservoir According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).
[0272] According to one embodiment, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 can be configured to encourage the air flow to travel a tortuous path through the reservoir 5110 while the air flow contacts a certain amount of water in the reservoir 5110.
[0273] According to one form, the reservoir 5110 may be laterally removable from the humidifier 5000, for example as shown in Figures 5A and 5B.
[0274] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air stream to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.
[0275] 5.6.2.2 Conductive parts According to one arrangement, the reservoir 5110 includes a conductive region 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive region 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive region 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.
[0276] 5.6.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to retain the reservoir 5110 within the humidifier reservoir dock 5130).
[0277] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any fraction thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)).
[0278] 5.6.2.5 Heating elements In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more of the volume of water in the humidifier reservoir 5110 and / or the volume of water to the airflow. The heating element 5240 may include a heat-generating component such as an electrical resistance heating track. One suitable example of the heating element 5240 is a layered heating element, for example, as described in PCT Patent Application Publication No. WO2012 / 171072, the entirety of which is incorporated herein by reference.
[0279] In some forms, the heating element 5240 may be provided in the humidifier base 5006. In the humidifier base 5006, heat may be transferred to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 5B.
[0280] 5.7 Glossary For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply.
[0281] 5.7.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to a combination of other breathable gases (e.g., oxygen-rich atmospheric air).
[0282] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) that which is external to the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.
[0283] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.
[0284] In another example, the ambient pressure may be the pressure immediately surrounding or external to the body.
[0285] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.
[0286] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy that is capable of automatically adjusting therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.
[0287] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airways increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to the detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).
[0288] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. Sometimes, when referring to flow rate, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when referring to flow rate, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be called "flow" or "airflow" for shorthand.
[0289] In the example of a patient's breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Vent flow rate Qv is the flow rate of air exiting the vent to allow for the outflow of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.
[0290] Humidifier: The word "humidifier" is construed to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial quantity of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.
[0291] Leak: The term "leak" refers to an unintended flow of air. In one example, a leak can occur due to an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the elbow to the perimeter.
[0292] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic pathway (e.g., the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.
[0293] Noise Emission (Acoustic): In this document, radiated noise refers to noise carried by the ambient air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target in accordance with ISO 3744.
[0294] Ventilation noise (acoustic): In this document, ventilation noise refers to the noise generated by airflow through any ventilation (eg, ventilation holes in the patient interface).
[0295] Patient: A person with or without a respiratory disease.
[0296] Pressure: Force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 which is approximately 0.98 hectopascals. In this specification, pressures are given in units of cmH2O unless otherwise specified.
[0297] The pressure in the patient interface is designated by the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this time, is designated by the symbol Pt.
[0298] Respiratory Pressure Therapy (RPT): The application to the airway entrance of an air supply at therapeutic pressure, typically positive pressure relative to atmosphere.
[0299] Ventilator: A mechanical device that provides pressure support to a patient while they perform some or all of the work of breathing.
[0300] 5.7.1.1 Materials Silicone or silicone elastomer: Synthetic rubber. References herein to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (in a family of products sold under this registered trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45, as measured by ASTM D2240.
[0301] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.
[0302] 5.7.1.2 Mechanical properties Resilience: The ability of a material to absorb energy during elastic deformation and to release the energy upon unloading.
[0303] Resilient: Releases substantially all of its energy upon unloading. Examples include certain silicone and thermoplastic elastomers.
[0304] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus or the indentation hardness scale measured on a standardized sample size). "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and do not easily deform under finger pressure, for example.
[0305] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component may offer different resistance in different directions.
[0306] Floppy structure or component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.
[0307] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application would be setting up and maintaining a patient interface in a sealed manner against a patient airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.
[0308] As one example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.
[0309] 5.7.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when flow below a predetermined threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.
[0310] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.
[0311] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.
[0312] Exercise (Respiration): Respiratory effort is said to refer to the movement made by the spontaneous breathing of a person trying to breathe.
[0313] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.
[0314] Flow limitation: Flow limitation is understood to be a condition in a patient's breathing where an increase in patient effort does not result in a corresponding increase in flow. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.
[0315] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat area, followed by a downswing. (ii) M-shaped: has two local peaks, one at the rise and one at the fall, with a relatively flat region between these two peaks. (iii) Chair-like: A single local peak occurs at the rising part, followed by a relatively flat region. (iv) Inverted chair: A relatively flat region is followed by a single local peak, which occurs on the trailing edge.
[0316] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when flow is reduced below a threshold rate for a sustained period of time. When hypopnea is detected due to a decrease in respiratory effort, central hypopnea is said to occur. In one form, hypopnea may be considered when any of the following occur in adults: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction in patient respiration (less than 50%) lasting at least 10 seconds and associated desaturation of at least 3% or arousal occurs.
[0317] Hyperventilation: An increase in flow to a level higher than normal.
[0318] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.
[0319] Patency (Airway): The degree to which the airway is open or the extent to which it is open. Airway patency is an opening. Airway patency can be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).
[0320] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.
[0321] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.
[0322] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory airflow, and are used in contrast to "true respiratory flow" or "true respiratory airflow," which is the patient's actual respiratory flow, usually expressed in liters / minute.
[0323] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume Vi (volume of air inhaled) is equal to the exhaled volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inhaled volume Vi and the exhaled volume Ve).
[0324] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.
[0325] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.
[0326] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.
[0327] Typical Recent Ventilation: The ventilation value around which recent values of ventilationVent over a given time scale tend to cluster (i.e., the degree to which recent values of ventilation tend to be centered).
[0328] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).
[0329] Vent: A measure of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inspiratory and expiratory flow per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood as volume per minute.
[0330] 5.7.3 Ventilation Adaptive servo-ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation but is variable. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's breathing characteristics).
[0331] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered to the patient by the ventilator (when not triggered by spontaneous breathing efforts).
[0332] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop breath delivery.
[0333] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are added within a breath to produce the desired mask pressure that the ventilator attempts to achieve at a given moment.
[0334] End Expiratory Pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ)=0 when Φ=1), then EEP is equal to EPAP.
[0335] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.
[0336] Pressure Support: A number indicating the increase in pressure during ventilator inspiration compared to the corresponding ventilator expiration, and refers primarily to the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support refers to the difference the ventilator attempts to achieve (rather than the difference it actually achieves).
[0337] Servo-ventilator: A ventilator that has both patient ventilation and target ventilation, and adjusts the level of pressure support to bring the patient ventilation closer to the target ventilation.
[0338] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device fails to detect a breath within a predetermined period of time, the device automatically begins breath delivery.
[0339] Swing: A term equivalent to pressure assistance.
[0340] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, the ventilator is said to be triggered to deliver a breath when the patient himself initiates the breathing portion of the breathing cycle.
[0341] 5.7.4 Anatomy 5.7.4.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar)
[0342] Wing angle:
[0343] Alare: The outermost point on the ala of the nose.
[0344] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each alar, found in the crease formed by the union of the alar and cheek.
[0345] Pinna: the entire visible part of the ear.
[0346] (Nasal) skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal portion of the frontal bone.
[0347] (Nasal) cartilaginous rami: The cartilaginous rami of the nose include the septal cartilage, lateral cartilage, greater cartilage, and lesser cartilage.
[0348] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.
[0349] Columella angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal and intersecting the subnasal point.
[0350] Frankfort horizontal plane: A line extending from the most inferior point of the orbital rim to the left auricular point, which is the deepest point of the auricle from the superior side of the notch to the tragus.
[0351] Glabellar: Located in the soft tissue, the most prominent point in the midsagittal direction of the forehead.
[0352] Lateral nasal cartilage: a generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla, and whose lower margin is connected to the greater alar cartilage.
[0353] Lip, lower side (lower lip: labrale inferius):
[0354] Lip, upper side (upper lip: labrale superius):
[0355] Alar cartilage: a cartilaginous plate located below the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.
[0356] Nostrils (nares): Generally ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nostrils is naris (nose hole). These nostrils are separated by the nasal septum.
[0357] Nasolabial fold or nasolabial crease: a fold or groove of skin that runs from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.
[0358] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.
[0359] Inferior ear point: lowest point of attachment of the pinna to the facial skin.
[0360] Superior auricular point: the highest point of attachment of the pinna to the facial skin.
[0361] Nasal tip: The most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head.
[0362] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.
[0363] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.
[0364] Nasal ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.
[0365] Sagittal plane: A vertical plane running from anterior (front) to posterior (rear). The midsagittal plane is the sagittal plane that divides the body into right and left halves.
[0366] Cerion: Located on the soft tissue, it is the most concave point on the area of the frontonasal suture.
[0367] Septal cartilage (nose): The nasal septum cartilage is part of the septum, which divides the anterior part of the nasal cavity.
[0368] Nasal alar nasal basin: the point on the lower periphery of the alar base where it joins with the skin of the upper (top) lip.
[0369] Subnasal point: Located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.
[0370] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion.
[0371] 5.7.4.2 Skull anatomy Frontal bone: The frontal bone contains the squama frontalis, a large vertical portion that corresponds to the area known as the forehead.
[0372] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw, forming the chin.
[0373] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward by the sides of the nose and forms part of its lateral border.
[0374] Nasal bones: The nasal bones are two small, rectangular bones that vary in size and shape from person to person. They lie side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.
[0375] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area directly between the eyes and the upper side of the bridge of the nose.
[0376] Occipital bone: The occipital bone is located at the back and underside of the skull. It contains the foramen magnum, an oval hole through which the intracranial cavity connects with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.
[0377] Orbit: bony cavity in the skull that contains the eyeball.
[0378] Parietal bones: The parietal bones are bones that, when joined together, form the top and sides of the skull.
[0379] Temporal bone: The temporal bone is located on the base and sides of the skull and supports parts of the face known as the temples.
[0380] Cheekbones: The two cheekbones in the face are located in the upper and lateral parts of the face and form the cheek ridges.
[0381] 5.7.4.3 Respiratory system anatomy Diaphragm: A sheet of muscle that runs over the lower rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.
[0382] Larynx: The larynx or voice box that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.
[0383] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchi, and terminal bronchioles. The respiratory zone includes the respiratory bronchi, alveolar ducts, and alveoli.
[0384] Nasal Cavity: The nasal cavity (or nasal fossa) is a large, air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or turbinates. The nasal cavity is anteriorly connected to the nose, and posteriorly to the choanae, which open into the nasopharynx.
[0385] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mid pharynx) (oral part of the pharynx), and the hypopharynx (low pharynx).
[0386] 5.7.5 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that vents to atmosphere in a fail-safe manner to reduce the risk of excessive CO2 rebreathing by the patient.
[0387] Elbow: An elbow is an example of a structure that directs the axis of airflow moving therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross section. In another form, the elbow may have an oval or rectangular cross section. In certain forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In certain forms, the elbow may be detachable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap during manufacturing, but cannot be removed by the patient.
[0388] Frame: Frame is taken to mean the mask structure that supports the tensile load between two or more points that connect the headgear. A mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.
[0389] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear may include a collection of one or more posts, ties, and stiffeners configured to position and hold the patient interface in place on the patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).
[0390] Membrane: Membrane is taken to mean a typically thin-walled element, preferably substantially non-resistant to bending and resistant to stretching.
[0391] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having walls that at least partially enclose a volume of space, the air in the volume being pressurized to exceed atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.
[0392] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("to seal"), it can refer to an effect. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.
[0393] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.
[0394] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.
[0395] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.
[0396] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there is little leakage of air flow from the swivel.
[0397] Tie (noun): A structure designed to resist tension.
[0398] Venting: (noun): A structure that allows airflow into the ambient atmosphere inside a mask or conduit, allowing clinically effective flushing of exhaled gases. For example, for clinically effective flushing, flow rates of about 10 liters / minute to about 100 liters / minute may be used depending on mask design and treatment pressure.
[0399] 5.7.6 Structural Shape Products of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an interior surface, and an exterior surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or interior) surface. In another example, the structure may include a first surface and a second surface.
[0400] To facilitate the description of the shape and surface of a three-dimensional structure, we first consider a cross section at a point p through the surface of the structure. See Figures 3B-3F. Figures 3B-3F show an example cross section at point p on the surface and an example of the resulting planar curve. Figures 3B-3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, the surface is described from the perspective of a fictitious little person standing upright on the surface.
[0401] 5.7.6.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).
[0402] Positive curvature: If the curve at p bends toward the outward normal, the curvature at that point is taken to have a positive value (if our fictitious little person were to walk away from point p, they would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are often called concave.
[0403] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, they can walk on a horizontal plane that is neither pointing up nor pointing down). See Figure 3D.
[0404] Negative curvature: If the curve at p bends away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this fictitious little person were to walk away from point p, they would have to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex.
[0405] 5.7.6.2 Curvature of a two-dimensional surface A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane containing the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same or different signs. Each curvature at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.
[0406] Principal curvature and direction: The directions of the normal plane in which the curvature of a curve reaches its maximum and minimum values are called the principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvature at p is the curvature in the principal direction.
[0407] Surface region: A set of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).
[0408] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).
[0409] Dome area: an area where the principal curvatures at each point have the same sign: either both positive ("concave dome") or both negative ("convex dome")
[0410] 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.
[0411] Planar region: A region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).
[0412] Surface Edge: The boundary or limit of a surface or area.
[0413] Path: In certain forms of the present technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the present technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A hypothetical person's path is a place they walk on a surface, similar to a path in a garden.)
[0414] Path Length: In certain forms of the present technology, "path length" is taken to refer to the distance along the surface from f(0) to f(1) (i.e., the distance along a path on the surface). There may be more than one path between two points on the surface, and such paths may have different path lengths. (The path length of a fictional person is the distance walked along the path on the surface.)
[0415] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. On a planar area, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (For a fictional person, straight-line distance corresponds to the distance as the crow flies.)
[0416] 5.7.6.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily exist within any particular plane. A space curve may be closed, i.e., it has no endpoint. A space curve may be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or impeller) may trace a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torsion is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve can be characterized with respect to the tangent, normal, and binormal vectors at that point.
[0417] 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 that points in the same direction as the curve at that point. If a fictional character were flying along the curve and fell off their vehicle at a particular point, the direction of the tangent vector would be the direction they would be traveling.
[0418] Unit normal vector: As the fictional character moves along the curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.
[0419] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (Figure 3O).
[0420] Oscillating plane: A plane containing a unit tangent vector and a unit principal normal vector. See Figures 3O and 3P.
[0421] Torsion of a Space Curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangential plane. A space curve that lies within a plane has zero torsion. If the space curve deviates from the tangential plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangential plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). Referring to Figure 3S, because T2 > T1, the magnitude of torsion near the top coil of the spiral in Figure 3S is greater than the magnitude of torsion of the bottom coil of the spiral in Figure 3S.
[0422] Referring to the right-hand rule in Figure 3P, a space curve that bends toward the right-hand binormal can be considered to have a positive right-hand twist (e.g., a right-hand spiral as shown in Figure 3S). A space curve that bends away from the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).
[0423] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve oriented in a left-handed binormal direction can be considered as having a positive left-handed twist (e.g., a left-handed spiral). Thus, a positive left-handed direction corresponds to a negative right-handed direction. See Figure 3T.
[0424] 5.7.6.4 Holes A surface may have one-dimensional holes (e.g., holes bounded by a planar or space curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by a planar curve.
[0425] A structure can have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire's inner surface. In another example, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, the cushion in FIG. 3L and the exemplary cross-section of FIG. 3L in FIGS. 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or its outlet) and can include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole through the structure shown in FIG. 3K and bounded by a surface as shown.
[0426] 5.8 Other Notes A portion of the disclosure of this patent document contains material that is entitled to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of this patent document or this patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.
[0427] Unless otherwise clearly indicated from the context and unless a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of the range, and for any other stated or intervening value in the stated range, is encompassed by the technology. The upper and lower limits of these intervening ranges, independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.
[0428] Furthermore, when a value or values are embodied herein as part of the present technology, unless otherwise specified, it is understood that such values may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.
[0429] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.
[0430] Although particular materials are described as being suitable for use in the construction of components, obvious alternative materials having similar properties may be substituted. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.
[0431] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.
[0432] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. The publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.
[0433] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps not specifically described.
[0434] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the claim limitations.
[0435] Although the technology herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details unnecessary for the practice of the technology. For example, although the terms "first" and "second" (etc.) are used, unless otherwise specified, these terms are not intended to indicate any order but are used to distinguish between separate elements. Furthermore, although the process steps in the method may be described or illustrated in an ordered manner, such an order is not required. Those skilled in the art will recognize that such an order can be changed and / or aspects thereof can be performed simultaneously or even synchronously.
[0436] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]
[0437] patient 1000 Sleeping Patient 1000 Bedmate: 1100 Patient Interface 3000 Seal forming structure 3100 Plenum Chamber 3200 Tendon 3210 Top point 3220 Bottom point 3230 Stabilizing structure 3300 Ventilation 3400 Connection port 3600 Forehead support part 3700 RPT Device 4000 Outer Housing 4010 Internal part 4012 Part 4014 Panel 4015 Chassis 4016 Handle 4018 Pneumatic Block 4020 Air Filter 4110 Inlet Air Filter 4112 Outlet Air Filter 4114 Muffler 4120 Muffler 4120 Inlet muffler 4122 Outlet muffler 4124 Pressure Generator 4140 Blower 4142 Controllable Blower 4142 Motor 4144 Anti-spillback valve 4160 Air Circuit 4170 Air Circuit 4171 Supplemental oxygen 4180 Electrical Components 4200 PCBA 4202 power supply 4210 Input Device 4220 Central Controller 4230 Converter 4270 tubular structure 4600 Pin 4601 woven structure 4602 Warp knitting yarn 4603 Warp thread 4604 Warp knitting yarn 4605 Weft 4606 Weft pile 4606 Weft knitting yarn 4607 Edge 4608 Weft knitting yarn 4609 Top end 4610 1st weft position 4612 Second weft position 4614 Structure 4616 Ridge 4618 Tanibe 4620 Inner arc 4622 outer arc 4624 Tension 4630 Table 4632 Table 4634 tubular structure 4635 tubular structure 4637 tubular structure 4639 tubular structure 4641 tubular structure 4643 tubular structure 4645 Sealed structure 4650 Exterior 4652 Inner surface 4654 Inner surface 4660 Point 4664 Weft knit pattern 4669 Connector 4670 Weft knit pattern 4671 Connector 4672 Circular loom 4700 Shuttle 4702 Bobbin 4704 First Shuttle 4710 Second Shuttle 4711 Third Shuttle 4712 4th Shuttle 4713 5th Shuttle 4714 6th Shuttle 4715 Conveying direction 4750 Thorn 4752 Selection Matrix 4800 Humidifier 5000 Humidifier inlet 5002 Humidifier outlet 5004 Humidifier Base 5006 Reservoir 5110 Conductive part 5120 Humidifier Reservoir Dock 5130 Lock lever 5135 Water Level Indicator 5150 heating element 5240
Claims
[Claim 1] 1. An apparatus for providing positive airway pressure therapy to a patient breathing through a respiratory cycle including an inhalation portion and an exhalation portion, the apparatus comprising: a controllable motor blower configured to rotate an impeller at an impeller speed to generate air at a positive pressure relative to ambient pressure; a housing for holding the motor blower, the housing including an inlet and a patient connection port, the patient connection port configured to deliver the positive pressure supply of air from the motor blower through an air circuit to a patient interface in use; a sensor for monitoring at least one of the pressure and flow rate of the air supply when under positive pressure and generating a sensor output; a controller configured to adjust operating parameters of the motor blower in response to the sensor output to maintain a minimum positive pressure within said patient interface during a therapy session by increasing the impeller speed during the inhalation portion of the breathing cycle and decreasing the impeller speed during the exhalation portion of the breathing cycle; an air circuit, the air circuit comprising: comprising a tubular structure, the tubular structure has a circular woven structure; the tubular structure is seamless along the length of the tubular structure; the tubular structure includes a plurality of warp yarns and a plurality of weft yarns; the plurality of weft yarns include a first monofilament weft yarn and a second monofilament weft yarn; the first monofilament weft yarn is disposed adjacent to at least one non-monofilament weft yarn, and the second monofilament weft yarn is also disposed adjacent to at least one non-monofilament yarn; The at least one non-monofilament yarn is disposed between a first monofilament weft yarn and a second monofilament weft yarn.
Citation Information
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