Blower for portable RPT devices

Abstract

The blower for the RPT therapy device includes a first impeller connected to a first side of a motor shaft. The first impeller includes a first wall having a first surface and a second surface facing the first surface. A first blade extends from the first surface, and a second blade extends from the second surface in the opposite direction from the first blade. A first stator is connected to a first side of the motor shaft and is positioned in series with the first impeller. The first stator includes a second wall having an outer surface and an inner surface that at least partially form a cavity. A third blade extends from the outer surface, and at least one first slot extends at least partially through at least one third blade. The cavity at least partially receives the first impeller. The airflow generated by the first impeller passes through at least one first slot.

Description

Technical Field

[0001] Part of the disclosure of this patent document contains content that is given copyright protection. The copyright owner has no objection if anyone copies this patent document or this patent disclosure for the purposes described in the patent files or records of the Patent Office, but retains all copyrights for other purposes.

[0002] [Cross - Reference to Related Applications] This application claims the priority of U.S. Provisional Application No. 63 / 463,135, filed on May 1, 2023, the entire contents of which are incorporated herein by reference.

[0003] Also, PCT Application No. PCT / AU2022 / 051321, filed on November 4, 2022, is also incorporated herein by reference in its entirety.

Background Art

[0004] This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use. [Description of Related Technologies] 2.2.1 The Human Respiratory System and Its Diseases

[0005] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0006] These airways contain a series of branch tubes, which become narrower, shorter, and more numerous as they extend deeper into the lungs. The primary function of the lungs is gas exchange, enabling oxygen to move from inhaled air to venous blood and carbon dioxide to move in the opposite direction. The trachea divides into the right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. Further division of the airways results in respiratory bronchioles, which eventually become alveoli. Gas exchange takes place in the alveolar region of the lungs, and this region is called the respiratory region. See *Respiratory Physiology*, 9th edition, 2012, by John B. West, Lippincott Williams & Wilkins.

[0007] A variety of respiratory diseases exist. Certain diseases can be characterized by specific events, such as apnea, hypopnea, or hyperventilation.

[0008] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory dysfunction, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases.

[0009] Obstructive sleep apnea syndrome (OSA), a type of sleep-disordered breathing (SDB), is characterized by events involving the closure or obstruction of the upper airway during sleep. This results from an abnormal narrowing of the upper airway combined with a normal decrease in muscle tone in the areas of the tongue, soft palate, and posterior oropharynx during sleep. As a result, affected individuals experience respiratory cessation typically lasting 30 to 120 seconds, sometimes as many as 200 to 300 times per night. Consequently, excessive daytime sleepiness is often present, and it can contribute to cardiovascular disease and brain injury. This syndrome is a common disorder, particularly prevalent in overweight middle-aged men, but patients often experience no symptoms. See U.S. Patent No. 4,944,310 (Sullivan) for further information.

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repeated awakenings from sleep, which result in severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] Respiratory failure is a general term for respiratory diseases in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following conditions:

[0012] Patients with respiratory failure (a form of respiratory disorder) may experience abnormal shortness of breath during exercise.

[0013] Obesity hyperventilation syndrome (OHS) is defined as the coexistence of severe obesity and chronic hypercapnia while awake, in the absence of other known causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

[0014] Chronic obstructive pulmonary disease (COPD) encompasses a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to airflow, prolonged expiratory phase of breathing, and reduced normal elasticity in the lungs. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include shortness of breath on exertion, chronic cough, and sputum production.

[0015] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of walking ability, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be classified into rapidly progressive and slowly progressive types: (i) rapidly progressive diseases: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive diseases: characterized by muscle damage that worsens over years and only slightly shorten life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of NMD respiratory failure include worsening general weakness, dysphagia, shortness of breath during exertion and at rest, fatigue, drowsiness, morning headache, and difficulty with attention and emotional changes.

[0016] Chest wall disorders are a group of thoracic deformities that result in inefficient connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can develop into severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0017] A range of therapies have been used to treat or improve this condition. Furthermore, individuals who are otherwise healthy may utilize such therapies to prevent the onset of respiratory illness. However, these therapies have many shortcomings. 2.2.2 Therapy

[0018] Various respiratory therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the respiratory disorders described above. 2.2.2.1 Respiratory pressure therapy

[0019] Respiratory pressure therapy (which differs from negative pressure therapy, such as tank ventilators or positive / negative pressure external ventilators (cuirass)) involves supplying air to the airway entrance at a controlled target pressure that is nominally positive pressure relative to the atmosphere throughout the patient's entire respiratory cycle.

[0020] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, the continuous positive airway pressure therapy acting as an air splint by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing upper airway obstruction. Because CPAP therapy for OSA is sometimes optional, patients may choose not to undergo such therapy for one or more reasons, such as discomfort, difficulty of use, high cost, or unattractiveness of the device.

[0021] Non-invasive ventilation (NIV) provides ventilatory support to a patient via the upper airway to assist the patient's breathing and / or maintain adequate oxygen levels in the body by completing some or all of the respiratory work. Ventilation support is provided through a non-invasive patient interface. NIV is used in the treatment of OHS, COPD, NMD, and forms of CSR and respiratory failure such as chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0022] Invasive ventilation (IV) assists ventilation in patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved. 2.2.2.2 Flow therapy

[0023] In all respiratory therapies, the delivery of a defined therapeutic pressure is not necessarily intended. In some respiratory therapies, the aim is to deliver an inspiratory flow profile over a target duration, and in some cases, to deliver a defined tidal volume by superimposing a positive pressure baseline pressure. In other cases, the interface to the patient's airway is "open" (seal released), and the respiratory therapy can complement only the patient's spontaneous breathing with a regulated gas or enriched gas flow. In one example, high flow therapy (HFT) is to provide a continuous, heated, humidified air flow at a "therapy flow" that can be maintained substantially constant throughout the respiratory cycle to the inlet of the airway through a released or open patient interface. The therapy flow is nominally set to exceed the patient's peak inspiratory flow. HFT is used for the treatment of OSA, CSR, respiratory insufficiency, COPD and other respiratory disorders. One mechanism of action is that the high flow of air at the airway inlet improves ventilation efficiency by flushing or washing out the CO2 exhaled from the patient's anatomic dead space. Therefore, HFT may be referred to as dead space therapy (DST). Other advantages include a warming effect and improved humidification (possibly due to the effect of secretion control), and the possibility of a gradual increase in airway pressure. As an alternative to a constant flow, the therapy flow may follow a profile that varies over the respiratory cycle.

[0024] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. A physician may prescribe a continuous flow of oxygen-enriched air at a prescribed oxygen concentration (fraction of oxygen in ambient air, 21% - 100%) to be delivered to the patient's airway at a prescribed flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.). 2.2.3 Respiratory Therapy System

[0025] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used to screen, diagnose or monitor a disease without performing a treatment.

[0026] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management. 2.2.3.1 Patient Interface

[0027] The patient interface can be used to connect the breathing apparatus to the wearer, for example, by providing an air flow to the entrance of the airway. The air flow can 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 applied, the patient interface can promote gas delivery at a pressure significantly different from the ambient pressure, for example, a positive pressure of about 10 cmH2O relative to the ambient pressure, by forming a seal with a certain area of the patient's face, and can effectively perform the therapy. In the case of other forms of therapy such as oxygen delivery, the patient interface is sufficient to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O シール and may not include. In the case of flow therapy such as nasal HFT, the patient interface delivers air to the nostrils but is configured to avoid a particularly complete seal. An example of such a patient interface is a nasal cannula. 2.2.3.1.1 Seal Formation Structure

[0028] The patient interface may include a seal formation structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal formation structure can directly affect the effectiveness and comfort of the patient interface.

[0029] Patient interfaces can be partially characterized according to their design intent to engage a seal-forming structure with the face during use. In one form of a patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of a patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and the nasal bridge region of the face. In one form of a patient interface, the seal-forming structure may include an element that surrounds the mouth region during use by forming a seal, for example, on the lower lip region of the face. In one form of a patient interface, the seal-forming structure may include a single element that surrounds both the nostril and mouth regions during use. These various types of patient interfaces may be known by a variety of names by their manufacturers, such as nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks.

[0030] A series of patient interface seal formation structures technologies are disclosed in the following patent applications, which have been transferred to RESMED Limited: WO 1998 / 004310, WO 2006 / 074513, and WO 2010 / 135785.

[0031] One form of nasal pillow is found in the Adam circuit manufactured by Puritan-Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), which was assigned to Puritan-Bennett Corporation.

[0032] ResMed Limited manufactures the following products incorporating a nasal pillow: SWIFT™ Nasal Pillow Mask, SWIFT™ II Nasal Pillow Mask, SWIFT™ LT Nasal Pillow Mask, SWIFT™ FX Nasal Pillow Mask, and MIRAGE LIBERTY™ Full Face Mask. The following patent applications, assigned to ResMed Limited, describe examples of nose pillow masks: International Patent Application WO2004 / 073778 (in particular, describing aspects of ResMed Limited's SWIFT® nose pillow), U.S. Patent Application 2009 / 0044808 (in particular, describing aspects of ResMed Limited's SWIFT® LT nose pillow), International Patent Applications WO2005 / 063328 and WO2006 / 130903 (in particular, describing aspects of ResMed Limited's MIRAGE LIBERTY full-face mask), and International Patent Application WO2009 / 052560 (in particular, describing aspects of ResMed Limited's SWIFT® FX nose pillow). 2.2.3.1.2 Positioning and Stabilization

[0033] The seal-forming structures of patient interfaces used in positive pressure air therapy are subjected to corresponding forces from air pressure that can inhibit the seal. Therefore, various techniques are used to position the seal-forming structures and maintain the seal relationship with the appropriate part of the face.

[0034] Adhesives are used in one technology. See, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, the use of adhesives can be unpleasant for some people.

[0035] In other technologies, one or more straps and / or stabilization harnesses are used. A large number of such harnesses suffer from one or more of the following: poor fit, bulkiness, discomfort, and cumbersome handling. 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0036] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the above-mentioned therapies. For example, the device can be activated to generate an airflow, which can then be delivered to the airway interface. The airflow can be pressure-controlled (in the case of respiratory pressure therapy) or flow-controlled (in the case of flow therapy such as high-frequency therapy (HFT). Therefore, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0037] Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that are not met by more general-purpose pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may have deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0038] One example of a specific requirement for a particular RPT device is acoustic noise.

[0039] Table of noise output levels for conventional RPT devices (measured on a single sample at 10 cmH2O in CPAP mode, according to the test method specified in ISO 3744). [Table 1]

[0040] One known RPT device used in the treatment of sleep-disordered respiratory disorders is the S9 sleep therapy system manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed STella® series of adult and pediatric ventilators) can treat a number of conditions, including, but not limited to, NMD, OHS, and COPD, by providing assistance for invasive and non-invasive, independent ventilation in a variety of patients.

[0041] The ResMed Elisee® 150 ventilator and the ResMed VSIII® ventilator can provide invasive and non-invasive dependent ventilation assistance suitable for adult or pediatric patients for the treatment of multiple diseases. These ventilators provide volumetric ventilation and pneumatic ventilation modes via single-limb or double-limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0042] Device designers may be presented with countless options. Since design criteria are often contradictory, a particular design choice is never routine or inevitable. Furthermore, the comfort and effectiveness of a particular aspect can be highly sensitive to even slight changes in one or more parameters. 2.2.3.3 Air Circuit

[0043] An air circuit is a conduit or tube constructed and positioned so that, during use, airflow moves between two components of a respiratory therapy system (e.g., an RPT device and a patient interface). In some cases, there may be separate limbs of the air circuit for inspiration and expiration. In other cases, a single-limb air circuit is used for both inspiration and expiration. 2.2.3.4 Humidifier

[0044] Delivering airflow without humidification can lead to airway dryness. When a humidifier is used with the RPT device and patient interface, humidifying gas is produced, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, warm air applied to the facial area within and around the patient interface is generally more comfortable than cold air. 2.2.3.5 Data Management

[0045] For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (for example, whether the patient is using their RPT device in accordance with one or more "compliance rules"). For example, a compliance rule for CPAP therapy might require a patient to use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, an RPT device provider (e.g., a healthcare provider) may manually collect data describing the patient's therapy using the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. If the healthcare provider determines that a patient has used their RPT device in accordance with the compliance rules, they may notify third parties that the patient is compliant.

[0046] In patient therapy, there may be other ways in which patients benefit from the communication of therapy data to third parties or external systems.

[0047] Existing processes for communicating and managing such data can be costly, time-consuming, and prone to errors. 2.2.3.6 Ventilation Technology

[0048] Some forms of treatment systems may include a ventilator for washing out exhaled carbon dioxide. This ventilator may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings). 2.2.4 Screening, diagnostic, and monitoring systems

[0049] Polysomnography (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary disorders, and typically requires specialized clinical staff for system application. In PSG, typically 15-20 tactile sensors are placed on the patient to record various bodily signals such as electroencephalography (EEG), electrocardiogram (ECG), electrooculography (EOG), and electromyography (EMG). PSG for sleep-disordered breathing involves observing the patient for two nights in a clinic, with one night dedicated to pure diagnosis and the second night to titration of therapeutic parameters by a clinician. Therefore, PSG is costly and inconvenient. Screening / diagnosis / monitoring of sleep-disordered breathing is particularly unsuitable for home use.

[0050] Generally, screening and diagnosis involve identifying a disease based on its signs and symptoms. Screening typically yields true / false results indicating whether a patient's SDB warrants further investigation, while diagnosis often provides clinically actionable information. Screening and diagnosis tend to be one-time processes, whereas monitoring the course of a disease can continue indefinitely. Some screening / diagnostic systems are designed solely for screening / diagnosis, while others can also be used for monitoring.

[0051] Clinical professionals can appropriately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinical professionals are unavailable or cannot be paid. Clinical professionals may have differing opinions regarding a patient's condition. Furthermore, a given clinical professional may apply different criteria depending on the time period. [Overview of the Initiative] [Problems that the invention aims to solve]

[0052] This technology relates to providing medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, wherein these medical devices have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability. [Means for solving the problem]

[0053] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0054] Another aspect of this technology relates to a method used in screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0055] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving a patient's respiratory therapy compliance.

[0056] One embodiment of this technology includes a respiratory pressure therapy (RPT) system comprising a patient interface and a pressure generator, the pressure generator configured to supply pressurized air to a patient wearing the patient interface.

[0057] The patient interface may include a seal-forming structure for sealing around the patient's airway and a plenum chamber for receiving a flow of pressurized air.

[0058] Another aspect of one form of this technology is an impeller for a pressure generator, which rotates to generate a flow of pressurized air.

[0059] Another aspect of one embodiment of the present technology is an impeller for a pressure generator, which includes a plurality of first blades extending in a first direction and a plurality of second blades extending in a second direction.

[0060] Another aspect of one form of this technology is a respiratory pressure therapy (RPT) system including a patient interface and a pressure generator, the pressure generator being supported on the patient's head by the patient interface when in use.

[0061] Another aspect of one embodiment of the present technology is a blower for an RPT therapy device, the blower comprising a motor, a motor shaft driven by the motor, and a first impeller connected to a first side of the motor shaft, the first impeller comprising a first wall having a first surface and a second surface facing the first surface, a plurality of first blades extending from the first surface, and a plurality of second blades extending from the second surface in the opposite direction to the plurality of first blades, and connected to the first side of the motor shaft and arranged in series with the first impeller A first stator comprising a second wall including an outer surface and an inner surface that at least partially form a cavity, a plurality of third blades extending from the outer surface, and at least one first slot extending at least partially through at least one of the plurality of third blades, wherein the cavity is configured to at least partially receive a first impeller, and the airflow generated by the first impeller is configured to pass through at least one first slot.

[0062] In some forms, a) the plurality of second blades are positioned within the cavity when the first impeller is positioned within the cavity, b) the plurality of first blades are substantially linear, c) the second blades are substantially linear, d) each blade of the plurality of first blades is substantially aligned with one of the blades of the plurality of second blades along the axial direction of the first impeller, e) the length of each blade of the plurality of first blades is different from the length of each blade of the plurality of second blades, and / or f) the length of each first blade is longer than the length of each second blade.

[0063] In some embodiments, a) the first wall of the first impeller includes a first outer diameter, b) a ring extends from a second surface of the first wall and includes a second outer diameter, c) the first outer diameter is greater than the second outer diameter, d) the first impeller hub extends through the first wall and / or e) the first impeller hub extends further in the opposite direction to a plurality of second blades.

[0064] In some forms, a) the multiple third blades include multiple axially extending portions and multiple circumferentially extending portions; b) the multiple axially extending portions are spaced apart from each other; c) each circumferentially extending portion of the multiple circumferentially extending portions extends between adjacent axially extending portions of the multiple axially extending portions; d) each circumferentially extending portion is in contact with one of the axially extending portions and spaced apart from adjacent axially extending portions; e) each circumferentially extending portion is spaced apart from each axially extending portion extending between them; and / or f) the multiple circumferentially extending portions are located on an outer wall.

[0065] In some forms, a) the hub extends in the opposite direction to the portion that extends axially, b) the housing receives a first impeller and a first stator, c) the housing includes an opening configured to function as an inlet, d) the opening exposes at least a portion of a plurality of first blades, e) the stator has a plurality of fourth blades configured to remain stationary during rotation of the motor shaft, f) the fourth blades are located on the inner surface of the stator, g) each of the fourth blades has a different length, h) the stator includes a connecting ring configured to connect to the hub, g) each of the fourth blades has a different length, h) the stator is connected to the hub i) the connecting ring and the hub are connected by a snap fit, including a connecting ring configured to allow a first impeller and a first stator, k) the stator includes at least one second slot extending into the hollow interior of the stator, l) the at least one second slot is configured to provide fluid communication to a fourth blade, m) the at least one first slot is aligned with the at least one second slot to form a flow path, and / or n) the first impeller is a left-side first impeller, the first stator is a left-side first stator, and the blower further includes a right-side first impeller and a right-side first stator.

[0066] Another aspect of one form of the present technology is a user interface configured to be worn by a user, the user interface comprising one of the blowers of the above forms and a blower housing configured to support the blower and direct airflow to the user.

[0067] Another aspect of one embodiment of the present technology is a user interface configured to be worn by a user, the user interface comprising: a blower of any one of the embodiments; a seal-forming structure configured to form a seal to the user's face; a headgear connected to the seal-forming structure and configured to maintain the seal-forming structure in a sealed position on the user's face; and a blower housing configured to support the blower and direct airflow toward the user, the blower housing being connected to the seal-forming structure to supply airflow to the user.

[0068] In some forms, blowers are patient interfaces for treating sleep-disordered breathing.

[0069] Another aspect of one form of this technology is a patient interface molded or otherwise constructed together with a peripheral shape that complements the shape of the intended wearer.

[0070] One embodiment of this technology is a method for manufacturing an apparatus.

[0071] One particular form of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, is not very dexterous, lacks insight, or has limited experience using this type of medical device.

[0072] One embodiment of this technology is, for example, a portable RPT device that can be used by the user at the user's home.

[0073] One embodiment of this technology is a patient interface that can be cleaned at the patient's home with, for example, soapy water, without the need for special cleaning equipment. Another embodiment of this technology is a humidifier tank that can be cleaned at the patient's home with, for example, soapy water, without the need for special cleaning equipment.

[0074] The methods, systems, devices, and apparatus described may be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the above methods, systems, devices, and apparatus can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0075] Of course, some aspects may form subordinate aspects of this technology. Furthermore, sub-aspects and / or various aspects may be combined in various ways to constitute additional aspects or sub-aspects of this technology.

[0076] Other features relating to this technology will become apparent by considering the information contained in the embodiments, abstract, drawings, and claims for carrying out the invention described below. [Brief explanation of the drawing]

[0077] This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements. 4.1 Respiratory Therapy System

[0078] [Figure 1A] The system includes a patient 1000 wearing a nasal pillow-shaped patient interface 3000 and receiving positive pressure air from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to patient 1000 through an air circuit 4170. A bedmate 1100 is also illustrated. The patient is sleeping in a supine position. [Figure 1B]The system includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000 in the form of a full-face mask that receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a side-lying position. 4.2 Anatomy of the Respiratory System and Face [Figure 2A] This diagram outlines the human respiratory system, including the nostrils and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] This diagram shows the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face, including several features of the surface anatomical structures, such as the upper lip, upper lip red, lower lip red, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, root of the nose, tip of the nose, subnasal point, upper lip, lower lip, supramenton, nasal ridge, apex of the nasal ala, superior and inferior base of the ear. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankforth horizontal and the nasolabial angle are indicated. The coronal plane is also shown. [Figure 2F] This is a pedicle view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and the median sagittal plane. [Figure 2G] This is a lateral view of the surface features of the nose. [Figure 2H]This shows the subcutaneous structure of the nose, including the lateral nasal cartilages, nasal septal cartilages, greater alar cartilages, lesser alar cartilages, nasal sesamoid cartilages, nasal bone, epidermis, adipose tissue, the frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I] This shows a mid-nasal incision located approximately a few millimeters from the midline sagittal plane, particularly the medial crura of the nasal septum cartilage and the greater alar cartilage. [Figure 2J] This is a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] A lateral view of the skull, the contour of the head surface, and several muscles are shown. The following bones are illustrated: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is shown. The following muscles are illustrated: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] An anterior-lateral view of the nose is shown. 4.3 Patient Interface [Figure 3A] This shows a patient interface in the form of a nasal mask according to one embodiment of this technology. [Figure 3B] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the magnitude of curvature shown in 3C. [Figure 3C] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 3E] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F]This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 3E. [Figure 3G] The mask cushion, including two pillows, is shown. The outer surface of the cushion is shown. The edges of the surface are shown. The dome and saddle regions are illustrated. [Figure 3H] A mask cushion is shown. The outer surface of the cushion is shown. The edges of the surface are shown. The path on the surface between point A and point B is illustrated. The straight-line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of the structure is shown, with one-dimensional holes present within it. The planar curves in the illustration form the boundaries of the one-dimensional holes. [Figure 3J] This is a cross-sectional view through the structure in Figure 3I. The illustrated surface defines the two-dimensional pores in the structure in Figure 3I. [Figure 3K] Figure 3I is a perspective view of the structure including two-dimensional and one-dimensional holes. The surface that borders the two-dimensional holes in the structure of Figure 3I is also shown. [Figure 3L] This shows a mask with an inflatable bladder that acts as a cushion. [Figure 3M] Figure 3L is a cross-sectional view of the mask, showing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 3N] Figure 3L shows a further cross-section through the mask. The inner surface is also illustrated. [Figure 3O] This demonstrates the left-hand rule. [Figure 3P] I will demonstrate the right-hand rule. [Figure 3Q] This shows the left ear, including the left helix. [Figure 3R] Shows the right ear, including the right helix. [Figure 3S] It shows a right-hand twist. [Figure 3T] This is a diagram of a mask, including signs of twisting of the spatial curve defined by the edges of the sealing membrane within different regions of the mask. [Figure 3U] This is a diagram of the plenum chamber 3200, showing the sagittal plane and the central contact surface. [Figure 3V] Figure 3U is a rear view of the plenum chamber. The directions in the figure are perpendicular to the central contact surface. In Figure 3V, the plenum chamber is divided into left and right halves by the sagittal plane. [Figure 3W] Figure 3V is a cross-sectional view through the plenum chamber, taken in the sagittal plane shown in Figure 3V. The "central contact" surface is illustrated. The central contact surface is perpendicular to the sagittal plane. The direction of the central contact surface corresponds to the orientation of tendon 3210. This tendon rests on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the shape of the cushion in this region, the central contact surface may contact both the upper and lower points. [Figure 3X] Figure 3U shows the plenum chamber 3200 in the use position on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the midline sagittal plane of the face when the plenum chamber is in the use position. The central contact surface generally corresponds to the "face plane" when the plenum chamber is in the use position. 4.4 RPT Device [Figure 4A] This figure shows an RPT device relating to one embodiment of this technology. [Figure 4B] This is a schematic diagram of the pneumatic path of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with reference to the blower and the 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. Articles located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] This is a schematic diagram of the electrical components of an RPT device according to one embodiment of this technology. [Figure 4D] This is a schematic diagram of an algorithm implemented in an RPT device according to one embodiment of this technology. 4.5 Humidifier [Figure 5A]An isometric view of a humidifier relating to one embodiment of this technology is shown. [Figure 5B] This shows an isometric view of a humidifier according to one embodiment of this technology, and the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Respiratory waveform [Figure 6] This shows a model of a typical human respiratory waveform during sleep. 4.7 Portable RPT Device [Figure 7] This is a perspective view of a portable RPT device for generating pressurized airflow. [Figure 8] Figure 7 is an exploded view of the portable RPT device. [Figure 9] Figure 7 shows an exploded view of the portable RPT device, including the motor. [Figure 10] Figure 7 is a cross-sectional perspective view of the RPT device. [Figure 11] Figure 7 is a cross-sectional view of the RPT device. [Figure 12] This is a top view of the first impeller illustrating the first set of blades. [Figure 13] Figure 12 is a bottom view of the first impeller illustrating a second set of blades. [Figure 14] This is a top view of the first stator illustrating a set of blades. [Figure 15] Figure 14 is a bottom view of the first stator. [Figure 16] Figure 14 is a top cross-sectional perspective view of the first stator. [Figure 17] Figure 14 is a cross-sectional bottom perspective view of the first stator. [Figure 18] This is a side cross-sectional view of the first stator in Figure 14. [Figure 19] This is a top view of a stator illustrating the connecting ring. [Figure 20] Figure 19 is a bottom view of the stator. [Figure 21] Figure 7 shows a patient interface perspective including a portable RPT device. [Modes for carrying out the invention]

[0079] Before describing the technology in further detail, please understand that the technology is not limited to the specific examples described herein and is subject to change. Also, please understand that the terms used in this disclosure are intended to illustrate only the specific examples described herein and are not intended to limit them.

[0080] The following explanation is provided in relation to various examples that may share one or more common properties and / or features. It should be understood that one or more features in any one example may be combined with one or more features in another example or other examples. In addition, any single feature or combination of features in any of these examples may constitute further examples. 5.1 Therapy

[0081] In one embodiment, the technology includes a method for treating respiratory diseases, which involves applying positive pressure to the airway entrance of 1000 patients.

[0082] In a specific example of this technology, a positive pressure air supply is provided to the patient's nasal pathway through one or both nostrils.

[0083] In certain applications of this technology, mouth breathing is restricted, limited, or prevented. 5.2 Respiratory Therapy Systems

[0084] In one embodiment, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 that supplies airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000. 5.3 Patient Interface

[0085] A non-invasive patient interface 3000 according to one aspect of this technology includes, as functional aspects, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation section 3400, a form of connection port 3600 for connection to an air circuit 4170, and a selective forehead support 3700. In some embodiments, the functional aspects may be provided by one or more physical placement elements. In some embodiments, one physical component may provide one or more functional aspects. When in use, the seal-forming structure 3100 is positioned to surround the patient's airway inlet(s) to maintain positive pressure at the patient's airway inlet(s). Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0086] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, that patient interface may not be suitable for respiratory pressure therapy.

[0087] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to supply air at a higher positive pressure than the surrounding environment.

[0088] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to supply air at a positive pressure at least 2 cmH2O higher than the surroundings.

[0089] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 4 cmH2O relative to the surroundings.

[0090] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply to the surroundings at a positive pressure of at least 6 cmH2O.

[0091] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings.

[0092] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply to the surroundings at a positive pressure of at least 20 cmH2O. 5.3.1 Seal-forming structure

[0093] In one embodiment of this technology, the seal-forming structure 3100 provides a target seal-forming region and can further provide a cushioning function. The target seal-forming region is the region on the seal-forming structure 3100 where a seal can occur. The region where sealing actually occurs (i.e., the actual seal surface) may vary from patient to patient in a given treatment session depending on a range of factors (e.g., the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0094] In one embodiment, the target seal-forming region is located on the outer surface of the seal-forming structure 3100.

[0095] In a particular form of this technology, the seal-forming structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0096] The seal-forming structure 3100 related to this technology can be constructed from a soft, flexible, and elastic material (for example, silicon).

[0097] In a particular embodiment of this technology, a system is provided comprising two or more seal-forming structures 3100, each seal-forming structure 3100 configured to accommodate different size and / or shape ranges. For example, the system may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another form suitable for small heads rather than large heads. 5.3.1.1 Sealing mechanism

[0098] In one embodiment, the seal-forming structure includes a sealing flange that uses a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0099] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than approximately 1 mm (e.g., approximately 0.25 mm to approximately 0.45 mm), which extends around the perimeter length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of its perimeter length. The support flange is or includes a spring-like element and functions to support the sealing flange so as not to buckle during use.

[0100] In one embodiment, the seal-forming structure may include a compression sealing portion or a gasket sealing portion. During use, the compression sealing portion or gasket sealing portion is constructed and positioned so that it is compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0101] In one embodiment, the seal-forming structure includes a tensioning portion. During use, the tensioning portion is held under tension by, for example, an adjacent region of the sealing flange.

[0102] In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface.

[0103] In certain embodiments of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface. 5.3.2 Plenum Chamber

[0104] The plenum chamber 3200 has a perimeter shape that complements the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 3200 is positioned close to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend substantially around the entire circumference of the plenum chamber 3200 during use. In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0105] In certain forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. In such forms, treatment compliance may be improved because it is less noticeable to the wearer and / or often increases wearer comfort.

[0106] In certain forms of this technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). The use of a transparent material can make the patient interface less conspicuous, which may help improve compliance with treatment. The use of a transparent material may also help clinicians confirm the position, shape, and function of the patient interface.

[0107] In a specific form of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material makes the patient interface less conspicuous, which can help improve compliance with treatment. 5.3.3 Positioning and stabilization structure

[0108] The seal-forming structure 3100 of the patient interface 3000 of this technology may be held in the sealing position during use by the positioning and stabilization structure 3300.

[0109] In one embodiment, the positioning and stabilizing structure 3300 provides at least sufficient holding force to overcome the positive pressure effect of the plenum chamber 3200 that separates from the face.

[0110] In one embodiment, the positioning and stabilizing structure 3300 provides sufficient holding force to overcome the attractive force on the patient interface 3000.

[0111] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force as a safety margin that eliminates the possibility of destructive forces on the patient interface 3000 (for example, those resulting from tube dragging or accidental interference with the patient interface). 5.3.4 Ventilation

[0112] In one embodiment, the patient interface 3000 includes a ventilation unit 3400 constructed and positioned to allow the washout of exhaled gases, such as carbon dioxide.

[0113] In a particular configuration, the ventilator 3400 is configured to allow a continuous ventilator flow from inside the plenum chamber 3200 to the environment, while simultaneously maintaining a positive pressure within the plenum chamber relative to the surroundings. The ventilator 3400 is configured to have a ventilator flow rate large enough to reduce rebreathing of CO2 exhaled by the patient while maintaining therapeutic pressure within the plenum chamber during use.

[0114] One embodiment of the ventilation unit 3400 relating to this technology includes a plurality of holes (for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0115] The ventilation unit 3400 may be located in the plenum chamber 3200. Alternatively, the ventilation unit 3400 may be located within a separate structure such as a swivel unit. 5.3.5 Separation structure (multiple structures possible)

[0116] In one embodiment, the patient interface 3000 includes at least one separate structure (e.g., a swivel or a bulbous fovea). 5.3.6 Connection Ports

[0117] Connection port 3600 allows connection to the air circuit 4170. 5.3.7 Forehead support

[0118] In one configuration, the patient interface 3000 includes a forehead support 3700. 5.3.8 Choking prevention valve

[0119] In one configuration, the patient interface 3000 includes an asphyxiation prevention valve. 5.3.9 Ports

[0120] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows direct measurement of the gas properties (e.g., pressure) within the plenum chamber 3200. 5.4 RPT Devices

[0121] An RPT device 4000 according to one aspect of this technology includes mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms 4300 (e.g., any of the methods described herein, either entirely or in part). The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for the treatment of one or more respiratory diseases described elsewhere herein.

[0122] In one embodiment, the RPT device 4000 is constructed and configured to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 2 cmH2O, or at least 42 cmH2O, or at least 62 cmH2O, or at least 102 cmH2O, or at least 202 cmH2O. In another embodiment, the RPT device 4000 can maintain a pressure equivalent to the ambient pressure.

[0123] The RPT device may have an external housing 4010 formed in two parts, an upper part 4012 and a lower part 4014. Furthermore, the external housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 supporting one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0124] The air path of the RPT device 4000 may include one or more air path articles, for example, 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 4272 and a flow sensor 4274).

[0125] One or more of the air passage articles may be located within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be located within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0126] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative configuration, the RPT device 4000 may include multiple PCBAs 4202. 5.4.1 Mechanical and pneumatic components of RPT devices

[0127] An RPT device may include one or more of the following components in a single unit. In an alternative configuration, one or more of the following components may be located as separate units. 5.4.1.1 Air filters (multiple filters allowed)

[0128] An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

[0129] In one configuration, the inlet air filter 4112 is located upstream of the pressure generator 4140 at the starting point of the pneumatic path.

[0130] In one configuration, an outlet air filter 4114, for example, an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000. 5.4.1.2 Muffler (multiple mufflers are possible)

[0131] An RPT device according to one embodiment of this technology may include a muffler 4120 or a plurality of mufflers 4120.

[0132] In one embodiment of this technology, the inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0133] In one embodiment of this technology, the outlet muffler 4124 is located within the pneumatic path between the pressure generator 4140 and the patient interface 3000. 5.4.1.3 Pressure Generator

[0134] In one embodiment of this technology, the pressure generator 4140 for generating a flow or supply of positive-pressure air is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be positioned in a spiral shape. The blower may be capable of supplying air at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O, at a speed of, for example, up to about 120 liters / minute, when performing respiratory pressure therapy. The blower is described in any one of the following patents or patent applications, namely U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479, and PCT International Patent Application Publication 2013 / 020167, the entire literature of which is incorporated herein by reference.

[0135] The pressure generator 4140 can be under the control of the therapy device controller 4240.

[0136] In other configurations, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a pressurized air reservoir), or a bellows. 5.4.1.4 Transducer(s)

[0137] The transducer may be located inside or outside the RPT device. An external transducer may be located on or form part of an air circuit, such as a patient interface. The external transducer may also be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device.

[0138] In one embodiment of this technology, one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate signals representing the characteristics of the airflow, such as the velocity, pressure, or temperature at that point in the pneumatic path.

[0139] In one embodiment of this technology, one or more transducers 4270 may be located in close proximity to the patient interface 3000.

[0140] In one configuration, the signal from transducer 4270 may be filtered by low-pass filtering, high-pass filtering, or band-pass filtering, etc. 5.4.1.4.1 Flow Sensor

[0141] The flow sensor 4274 related to this technology may be based on a pressure difference transducer, for example, a pressure difference transducer from SENSIRION's SDP600 series.

[0142] In one configuration, the signal representing the flow rate, generated by the flow sensor 4274, is received by the central controller 4230. 5.4.1.4.2 Pressure Sensor

[0143] The pressure sensor 4272 in this technology is positioned to communicate with both the pneumatic path and the fluid. A suitable example of a pressure sensor is a transducer from the HONEYWELL ASDX series. A suitable alternative pressure sensor is the NPA series transducer from GENERAL ELECTRIC.

[0144] In one configuration, the pressure signal generated by the pressure sensor 4272 and representing the pressure is received by the central controller 4230. 5.4.1.4.3 Motor Speed ​​Transducer

[0145] In one embodiment of this technology, the motor speed sensor 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer 4276 can be supplied to the therapy device controller 4240. The motor speed sensor 4276 may be a speed sensor such as a Hall effect sensor. 5.4.1.5 Anti-spillback valve

[0146] In one embodiment of this technology, the 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, for example, to the motor 4144. 5.4.2 Electrical Components of an RPT Device 5.4.2.1 Power supply

[0147] The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0148] In one embodiment of this technology, the power supply 4210 supplies power only to the RPT device 4000. In another embodiment of this technology, the power supply 4210 supplies power to both the RPT device 4000 and the humidifier 5000. 5.4.2.2 Input Devices

[0149] In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or turntables that enable a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessible via a touchscreen. In one embodiment, the buttons, switches, or dials may be physically connected to an external housing 4010, or in another embodiment, they may be wirelessly connected to a receiver electrically connected to a central controller 4230.

[0150] In one embodiment, the input device 4220 may be configured and positioned to allow a person to select a value and / or a menu option. 5.4.2.3 Central Controller

[0151] In one embodiment of this technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0152] Suitable processors may include x86 Intel processors, processors based on ARM® Cortex®-M processors from ARM Holdings (e.g., STM32 series microphone controllers from ST MICROELECTRONICS). In certain alternative forms of this technology, 32-bit RISC CPUs such as ST MICROELECTRONICS' STR9 series microphone controllers manufactured by TEXAS INSTRUMENTS, or 16-bit RISC CPUs such as processors from the MSP430 family of microphone controllers may also be suitable.

[0153] In one embodiment of this technology, the central controller 4230 is a dedicated electronic circuit.

[0154] In one embodiment, the central controller 4230 is an application-specific integrated circuit. In another embodiment, the central controller 4230 includes separate electronic components.

[0155] The central controller 4230 may be configured to receive input signals(s) from one or more transducers 4270, one or more input devices 4220, and a humidifier 5000.

[0156] The central controller 4230 may be configured to provide output signals to one or more of the output devices 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0157] In some embodiments of this technology, the central controller 4230 is configured to implement one or more algorithms 4300, which can be implemented by processor control instructions expressed as computer programs stored in a non-temporary computer-readable storage medium (e.g., memory 4260), for example, one or more methodologies described herein. In some embodiments of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some embodiments of this technology, some methodologies may be performed by a remotely located device. For example, a remotely located device may analyze stored data, such as data from any of the sensors described herein, to determine ventilator control settings or detect respiratory-related events. 5.4.2.4 Clock

[0158] The RPT device 4000 may include a clock 4232 connected to the central controller 4230. 5.4.2.5 Therapeutic Device Controllers

[0159] In one embodiment of this technology, the therapy device controller 4240 is a therapy control module 4330 that forms part of an algorithm 4300 executed by the central controller 4230.

[0160] In one embodiment of this technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an ONSEMI MC33035 brushless DC motor controller is used. 5.4.2.6 Protection circuit

[0161] One or more protective circuits 4250 relating to this technology may include electrical protection circuits, temperature and / or pressure safety circuits. 5.4.2.7 Memory

[0162] According to one embodiment of this technology, the RPT device 4000 includes a memory 4260, for example, a non-volatile memory. In some embodiments, the memory 4260 may include a battery-powered static RAM. In some embodiments, the memory 4260 may include a volatile RAM.

[0163] Memory 4260 may be located on PCBA 4202. Memory 4260 may take the form of EEPROM or NAND flash.

[0164] Additionally or alternatively, the RPT device 4000 includes the form of a removable memory 4260, such as a memory card manufactured in accordance with the Secure Digital (SD) standard.

[0165] In one embodiment of this technology, the memory 4260 functions as a non-temporary computer-readable storage medium that stores computer program instructions representing one or more methodologies described herein, for example, one or more algorithms 4300. 5.4.2.8 Data Communication System

[0166] In one embodiment of this technology, a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 may be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0167] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0168] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may connect to the Internet using wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE).

[0169] In one configuration, the local external communication network 4284 uses one or more communication standards (e.g., Bluetooth or consumer infrared protocol).

[0170] In one embodiment, the remote external device 4286 is one or more computers, for example, a cluster of networked computers. In another embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by a properly authorized person, such as a clinician.

[0171] The local external device 4288 may be a personal computer, mobile phone, tablet, or remote control. 5.4.2.9 Output devices including optical displays, alarms

[0172] The output device 4290 according to this technology may take the form of one or more of the visual, auditory, and tactile units. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display. 5.4.2.9.1 Display Driver

[0173] The display driver 4292 receives characters, symbols, or images intended to be displayed on the display 4294 as input and converts them into commands to display them on the display 4294. 5.4.2.9.2 Display

[0174] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an 8-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the digit "0") into eight logical signals indicating whether eight corresponding segments are activated to display a particular character or symbol. 5.4.3 RPT Device Algorithm

[0175] As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300, expressed as computer programs stored in a non-temporary computer-readable storage medium such as memory 4260. The algorithms 4300 are grouped into groups generally called modules.

[0176] In other forms of this technology, part or all of the algorithm 4300 may be implemented by a controller of an external device (e.g., a local external device 4288 or a remote external device 4286). In such a form, input signals and / or intermediate algorithm output data necessary to represent part of the algorithm 4300 to be executed on the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In such a form, the part of the algorithm 4300 to be executed on the external device may be stored in a non-temporary computer-readable storage medium accessible from the controller of the external device and may be represented as a computer program including processor control instructions to be executed by one or more processors. The controller of the external device is configured by such a program to execute part of the algorithm 4300.

[0177] In such a configuration, therapeutic parameters generated by an external device via the therapeutic engine module 4320 (if such configuration forms part of an algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 and sent to the therapeutic control module 4330. 5.4.3.1 Preprocessing Module

[0178] A preprocessing module 4310 according to one embodiment of this technology receives signals from a transducer 4270, for example, a flow sensor 4274 or a pressure sensor 4272, as input, and performs one or more process steps to calculate one or more output values ​​to be used as input to another module, for example, a therapy engine module 4320.

[0179] In one embodiment of this technology, the output values ​​include interface pressure Pm, ventilation flow rate Qv, breathing flow rate Qr, and leakage flow rate Ql.

[0180] In various forms of this technology, the preprocessing module 4310 includes one or more algorithms from among the interface pressure estimation algorithm 4312, the ventilation flow rate estimation algorithm 4314, the leak flow rate estimation algorithm 4316, and the respiratory flow rate estimation algorithm 4318. 5.4.3.1.1 Interface Pressure Estimation

[0181] In one embodiment of this technology, the interface pressure estimation algorithm 4312 receives as input a signal from a pressure sensor 4272 indicating the pressure in the pneumatic path adjacent to the outlet of the pneumatic block (device pressure Pd) and a signal from a flow sensor 4274 indicating the flow rate of the airflow exiting the RPT device 4000 (device flow rate Qd). The device flow rate Qd can be used as the total flow rate Qt in the absence of supplemental gas 4180. The interface pressure estimation algorithm 4312 estimates the pressure drop ΔP through the air circuit 4170. The dependence of the pressure drop ΔP on the total flow rate Qt can be modeled for a particular air circuit 4170 by the pressure drop characteristic ΔP(Q). The interface pressure estimation algorithm 4312 then provides the estimated pressure Pm as output to the patient interface 3000. The pressure Pm in the patient interface 3000 can be estimated as the device pressure Pd minus the air circuit pressure drop ΔP. 5.4.3.1.2 Ventilation Flow Rate Estimation

[0182] In one embodiment of this technology, the ventilation flow rate estimation algorithm 4314 receives the estimated pressure Pm at the patient interface 3000 as input from the interface pressure estimation algorithm 4312, and estimates the ventilation flow rate Qv of air from the ventilation unit 3400 at the patient interface 3000. The dependence of the ventilation flow rate Qv on the interface pressure Pm at a particular ventilation unit 3400 in use can be modeled by the ventilation characteristic Qv(Pm). 5.4.3.1.3 Leakage Flow Rate Estimation

[0183] In one embodiment of this technology, the leak flow rate estimation algorithm 4316 takes a total flow rate Qt and a ventilation flow rate Qv as inputs and provides an estimated value of the leak flow rate Ql as an output. In one embodiment, the leak flow rate estimation algorithm estimates the leak flow rate Ql by calculating the average value of the difference between the total flow rate Qt and the ventilation flow rate Qv over a time period long enough to include several breathing cycles (e.g., 10 s).

[0184] In one embodiment, the leak flow rate estimation algorithm 4316 takes the total flow rate Qt, the ventilation flow rate Qv, and the estimated pressure Pm at the patient interface 3000 as inputs and supplies the leak flow rate Ql as an output, by calculating the leak conductance and determining the leak flow rate Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered unventilated flow rate equal to the difference between the total flow rate Qt and the ventilation flow rate Qv, and the low-pass filtered square root of the pressure Pm, where the low-pass filtered time constant has a value long enough to include several respiratory cycles, for example, about 10 seconds. The leak flow rate Ql may also be estimated as a function of the product of the leak conductance and the pressure Pm. 5.4.3.1.4 Respiratory flow estimation

[0185] In one embodiment of this technology, the respiratory flow rate estimation algorithm 4318 receives the total flow rate QT, the ventilation flow rate Qv, and the leakage flow rate Ql as inputs, and estimates the air breathing flow rate Qr for the patient by subtracting the ventilation flow rate Qv and the leakage flow rate Ql from the total flow rate Qt. 5.4.3.2 Therapy Engine Module

[0186] In one embodiment of this technology, the therapy engine module 4320 receives one or more of the pressure Pm and the air breathing flow rate Qr to the patient as inputs within the patient interface 3000, and provides one or more therapy parameters as outputs.

[0187] In one form of this technology, the therapeutic parameter is the therapeutic pressure Pt.

[0188] In one form of this technology, the therapeutic parameters are one or more of the following: pressure fluctuation amplitude, base pressure, and target ventilation.

[0189] In various forms, the therapy engine module 4320 includes one or more algorithms from among the following: phase determination algorithm 4321, waveform determination algorithm 4322, ventilation determination algorithm 4323, inspiratory flow limitation determination algorithm 4324, apnea / hypopnea determination algorithm 4325, snoring determination algorithm 4326, airway patency determination algorithm 4327, target ventilation determination algorithm 4328, and therapy parameter determination algorithm 4329. 5.4.3.2.1 Phase determination

[0190] In one embodiment of this technology, the RPT device 4000 does not determine the phase.

[0191] In one embodiment of this technology, the phase determination algorithm 4321 receives a signal indicating the respiratory flow rate Qr as input and provides the phase Φ of the current respiratory cycle of patient 1000 as output.

[0192] In some forms, this is called discrete phase determination, where the phase output Φ is a discrete variable. One implementation of discrete phase determination provides a binary phase output Φ with values ​​for inhalation or exhalation, for example, 0 and 0.5 rotations, respectively, when the start of spontaneous inhalation and exhalation are detected, respectively. The RPT device 4000, which "triggers" and "loops," can efficiently perform discrete phase determination because the trigger and loop points are the moments when the phase changes from exhalation to inhalation and from inhalation to exhalation, respectively. In one implementation of binary phase determination, if the respiratory flow rate Qr is above a positive threshold, the phase output Φ is determined to a discrete value of 0 (thus "triggering" the RPT device 4000), and if the respiratory flow rate Qr is below a negative threshold, it is determined to a discrete value of 0.5 rotations (thus "cycles" the RPT device 4000). The inspiratory time Ti and expiratory time Te can be estimated as typical values ​​for many respiratory cycles, representing the time spent in phase Φ, which is equal to 0 (representing inspiration) and 0.5 (representing expiration), respectively.

[0193] Another implementation of discrete phase determination provides a tri-phase output Φ having one of the following values: inhalation, pause during inhalation, or exhalation.

[0194] In another form called continuous phase determination, the phase output Φ is a continuous variable, such as changing from 0 to 1 revolution or from 0 to 2π radians. The RPT device 4000, which performs continuous phase determination, can be triggered and looped when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one implementation of continuous phase determination, a continuous value of phase Φ is determined using fuzzy logic analysis of the respiratory flow rate Qr. The continuous phase value determined in this implementation is generally called the "fuzzy phase". In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr.

[0195] If Qr is zero and increases rapidly, then Φ is considered to have 0 rotations.

[0196] If Qr is large and stable and positive, then Φ is set to 0.25 rotations.

[0197] If Qr is zero and rapidly decreasing, then Φ is set to 0.5 rotations.

[0198] If Qr is stable and significantly negative, then Φ is set to 0.75 rotations.

[0199] If Qr is stable at zero and the absolute value of Qr after 5-second low-pass filtering of the respiratory flow rate is large, then Φ should be set to 0.9 rotations.

[0200] If Qr is positive and the phase is exhalation, then Φ is set to 0 rotations.

[0201] If Qr is negative and the phase is inhalation, then Φ is set to 0.5 rotations.

[0202] If the absolute value of the Qr of the respiratory flow rate after 5 seconds of low-pass filtering is large, Φ increases at a steady rate equal to the patient's respiratory rate and is low-pass filtered with a time constant of 20 seconds.

[0203] The output of each rule can be represented as a vector having a phase, which is the result of the rule, and a magnitude, which is the degree of ambiguity to which the rule is true. The respiratory flow rate is a degree of fuzzyness, such as "large" or "stable," and is determined by an appropriate membership function. The results of the rules are represented as vectors and are joined by several functions, such as centroid. In this combination, the weights of the rules may be equal or different.

[0204] In another implementation of continuous phase determination, the phase Φ is first discretely estimated based on the respiratory flow rate Qr from the inspiratory time Ti and expiratory time Te, as described above. The continuous phase Φ at any given time can be obtained by adding 0.5 rotations to either half the proportion of the inspiratory time Ti elapsed since the previous trigger time, or half the proportion of the expiratory time Te elapsed since the previous cycle time (whichever time is closer). 5.4.3.2.2 Waveform Determination

[0205] In one embodiment of this technology, the therapy parameter determination algorithm 4329 provides a nearly constant therapeutic pressure throughout the patient's entire respiratory cycle.

[0206] In another embodiment of this technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapeutic pressure Pt that changes as a function of the phase Φ of the patient's respiratory cycle, according to a waveform template Π(Φ).

[0207] In one embodiment of this technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having a value in the domain range [0, 1] of the phase value Φ used by the therapy parameter determination algorithm 4329.

[0208] In one form, applicable to discrete or continuous phases, the waveform template Π(Φ) is a square wave template where the value is 1 for phase values ​​less than 0.5 turns and 0 for phase values ​​of 0.5 turns or more. In the form suitable for continuous phases, the waveform template Π(Φ) has two smoothly curved portions, namely the smoothly curved portion (e.g., rising cosine) where the phase value rises from 0 to 1 up to 0.5 turns, and the smooth bend (e.g., exponentially for phase values ​​greater than 0.5 turns) decays from 1 to 0. In the form suitable for continuous phases, the waveform template Π(Φ) is based on a square wave, but the phase value rises smoothly from 0 to less than 0.5 turns for a "rise time", and during the "fall time" after 0.5 turns, the phase value falls smoothly from 1 to 0, with a "fall time" of less than 0.5 turns.

[0209] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a waveform template library according to the settings of the RPT device. Each waveform template Π(Φ) in the library can be provided as a lookup table of values ​​Π for a phase value Φ. In other forms, the waveform determination algorithm 4322 uses a predetermined functional form (which may be parameterized by one or more parameters (e.g., time constants of the exponential curve portion)) to calculate the waveform template Π(Φ) "dynamically". The parameters of the functional form may be predetermined or may depend on the current state of patient 1000.

[0210] In some forms of this technology, it is applied to discrete binary phases of inhalation (Φ=0 rotations) or exhalation (Φ=0.5 rotations), and the waveform determination algorithm 4322 immediately calculates the waveform template Π "dynamic" as a function of discrete phase Φ measured since the most recent trigger moment and time t. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ, t) as two parts (inhalation and exhalation) as follows:

[0211]

number

[0212] In one embodiment of this technology, the ventilation determination algorithm 4323 receives the respiratory flow rate Qr as input and determines a measurement that indicates the current patient ventilation vent.

[0213] In some implementations, the ventilation determination algorithm 4323 determines a measured tidal volume, which is an estimate of the actual patient tidal volume vent. In one such implementation, half of the absolute value of the respiratory flow rate Qr is taken, or filtered through a low-pass filter such as a second-order Bézier low-pass filter with a corner frequency of 0.11 Hz.

[0214] In other embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation vent that is substantially proportional to actual patient ventilation. In one such embodiment, the peak respiratory flow rate Qpeak of the estimated cycle inhalation interval is realized. This procedure, along with many other procedures involving sampling of the respiratory flow rate Qr, results in a measured value that is approximately proportional to ventilation, provided that the shape of the flow waveform does not change much (here, two breaths are considered to have similar shapes if the respiratory flow waveforms normalized by time and amplitude are similar). Simple examples include the median of the positive respiratory flow rates, the median of the absolute values of the respiratory flow rates, and the standard deviation of the flow rates. Any linear combination of any order statistics of the absolute values of the respiratory flow rates using positive coefficients, or even those using both positive and negative coefficients, is approximately proportional to the ventilation volume. Another example is the average value of the respiratory flow rate at the K-th percentage (time) in the middle of the inhalation portion, where <K<1. When the flow shape does not change, there are arbitrarily multiple measured values that are proportional to the completeness of ventilation. 5.4.3.2.4 Determination of Inhalation Flow Rate Limitation

[0215] In one form of the present technology, the central controller 4230 executes an inhalation flow rate limitation determination algorithm 4324 to determine the degree of inhalation flow rate limitation.

[0216] In one form, the inhalation flow rate limitation determination algorithm 4324 receives the inhalation flow rate signal Qr as an input and provides, as an output, a measure of the degree to which the inhalation portion of the breath indicates an inhalation flow rate limitation.

[0217] In one embodiment of this technology, the inspiratory portion of each breath is identified by a zero-crossing detector. Along the inspiratory flow-time curve of each breath, multiple equally spaced points (e.g., 65) representing each time point are interpolated using an interpolator. The curve described by the points is then scaled scalarly to have a uniform length (duration / cycle) and uniform area to eliminate the effects of changes in respiratory rate and depth. The scaled breath is then compared in a comparator to a pre-stored template representing a normal open breath, similar to the inspiratory portion of the breath shown in Figure 6A. Any breath that deviates from this template by a predetermined threshold (usually 1 proportional unit) at any point during inspiration, such as a cough, sigh, swallow, or hiccup, as determined by the test element, is rejected. For data that is not rejected, the moving average of the first such scaled points for several of the aforementioned inspiratory events is calculated by the central controller 4230. For such a second point, this is repeated for the same inspiratory event, and so on. Therefore, for example, 65 scaled data points are generated by the central controller 4230, representing the moving average of the first few inspiratory events (e.g., three events). The moving average of the (e.g., 65) points of continuous updates is hereafter referred to as the "scaled flow rate" and defined as Qs(t). Alternatively, a single inspiratory event may be used instead of the moving average.

[0218] From the scaling flow rate, two shape factors associated with the determination of partial occlusion can be calculated.

[0219] The shape factor of 1 is the ratio of the average of intermediate (e.g., 32) scaling flow points to the average of all (e.g., 65) scaling flow points. A ratio greater than 1 indicates normal respiration. A ratio less than or equal to 1 indicates respiratory obstruction. A ratio of approximately 1.17 is used as a threshold between partial and ano-obstructive respiration and is equivalent to the degree of obstruction that allows for adequate oxygenation in a typical patient.

[0220] The shape factor 2 is calculated as the mean square deviation from the unit scaling flow rate and is defined as exceeding the median value (e.g., 32). A mean square deviation of approximately 0.2 units is considered normal. A mean square deviation of zero is considered to represent a completely flow-restricted respiration. The closer the mean square deviation is to zero, the more flow-restricted the respiration is.

[0221] Shape factors 1 and 2 can be used as alternatives or in combination. In other forms of this technique, the number of sampling points, breathing points, and intermediate points may differ from those described above. Also, the threshold may differ from the threshold described. 5.4.3.2.5 Determination of Apnea and Hypopnea

[0222] In one embodiment of this technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea.

[0223] In one embodiment, the apnea / hypopnea determination algorithm 4325 receives a respiratory flow signal Qr as input and provides a flag as output indicating that apnea or hypopnea has been detected.

[0224] In one form, apnea can be detected when the respiratory flow rate (Qr) function falls below a flow threshold over a predetermined period of time. This function can be used to determine the peak flow rate, the relative short-term mean flow rate, or the midpoint flow rate between the relative short-term mean and peak flow rates, such as the RMS flow rate. The flow threshold may be a relatively long-term measure of flow rate.

[0225] In one embodiment, hypopnea is detected if the respiratory flow rate Qr falls below a second flow threshold over a predetermined period of time. This function can determine the peak flow rate, the relative short-term mean flow rate, or the midpoint flow rate between the relative short-term mean and peak flow rates, e.g., the RMS flow rate. The second flow threshold may be a relatively long-term measure of flow rate. The second flow threshold is greater than the flow threshold used to detect apnea. 5.4.3.2.6 Determining Snoring

[0226] In one aspect of the present technology, the central controller 4230 executes one or more snoring determination algorithms 4326 to determine the degree of snoring.

[0227] In one aspect, the snoring determination algorithm 4326 receives the respiratory flow signal Qr as an input and provides a measure of the degree of presence of snoring as an output.

[0228] The snoring determination algorithm 4326 may include the step of determining the intensity of the flow signal in the range of 30 to 300 Hz. Further, the snoring determination algorithm 4326 may include the step of filtering the respiratory flow signal Qr to reduce background noise, for example, the sound of the airflow within the system from the blower. 5.4.3.2.7 Determination of airway patency

[0229] In one aspect of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 to determine the degree of airway patency.

[0230] In one aspect, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as an input and determines the power of the signal in the frequency ranges of approximately 0.75 Hz and approximately 3 Hz. The presence of a peak within this frequency range indicates that the airway is open. The absence of a peak is considered to indicate airway closure.

[0231] In one aspect, the frequency range for finding the peak is the frequency of a small forced vibration at the treatment pressure Pt. In one implementation, the frequency of the forced oscillation is 2 Hz and the amplitude is approximately 1 cmH2O.

[0232] In one aspect, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as an input and determines the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is considered a sign of airway closure. 5.4.3.2.8 Determination of target ventilation

[0233] In one embodiment of this technology, the central controller 4230 takes the current ventilation measurement value vent as input and executes one or more target ventilation determination algorithms 4328 to determine the target value Vtgt of the ventilation measurement.

[0234] In some forms of this technology, the target ventilation determination algorithm 4328 is absent, and the target value Vtgt is predetermined, for example, by hardcoding during the configuration of the RPT device 4000, or by manual input via the input device 4220.

[0235] In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp that represents the patient's typical recent ventilation.

[0236] In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a high percentage of the typical recent ventilation Vtyp, but smaller. Such high percentages may range from (80%, 100%), (85%, 95%), to (87%, 92%).

[0237] In other forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a unit multiple that is slightly larger than the typical recent ventilation Vtyp.

[0238] Typical recent ventilation Vtyp is a value that indicates the tendency of the distribution of current ventilation Vent measurements at multiple points in time over a given time scale to converge; in other words, it is a measure of the central trend of current ventilation volume measurements over recent history. In the implementation form of target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case it must be longer than the time scale of the Cheyne-Stokes upper and lower quarter cycles. Target ventilation determination algorithm 4328 can use any of various known convergence trend measurements to determine typical recent ventilation Vtyp from current ventilation measurement vent. One such measurement is the output of a low-pass filter on the current ventilation vent measurement, with a time constant equal to 100 seconds. 5.4.3.2.9 Determination of Therapeutic Parameters

[0239] In some forms of this technology, the central controller 4230 executes one or more therapy parameter determination algorithms 4329 to determine one or more therapy parameters using values ​​returned by one or more other algorithms in the therapy engine module 4320.

[0240] In one embodiment of this technology, the therapeutic parameter is the instantaneous therapeutic pressure Pt. In one implementation of this embodiment, the therapeutic parameter determination algorithm 4329 determines the therapeutic pressure Pt using the formula.

[0241]

number

[0242] If the waveform determination algorithm 4322 provides a waveform template as a lookup table of values ​​Π(Φ,t) indexed by phase Φ, the therapy parameter determination algorithm 4329 applies equation (1) by either locating the position of the lookup table entry closest to the current phase value Φ returned by the phase determination algorithm 4321, or by interpolating between two entries that straddle the current phase value Φ.

[0243] Depending on the selected respiratory pressure therapy mode, the values ​​of amplitude A and base pressure P0 can be set as follows by the therapy parameter determination algorithm 4329. 5.4.3.3 Therapy Control Module

[0244] The therapy control module 4330 according to one aspect of the present technology receives therapy parameters as an input from the therapy parameter determination algorithm 4329 of the therapy engine module 4320, and controls the pressure generator 4140 to deliver a gas flow according to the therapy parameters.

[0245] In one form of the present technology, the therapy parameter is the treatment pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver an air flow such that the interface pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt. 5.4.3.4 Detection of Fault States

[0246] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detecting fault states. The fault states detected by the one or more methods 4340 are Power off (power off or insufficient power off) Sensor fault detection Failure to detect the presence of a component Operating parameters outside the recommended range (pressure, flow rate, temperature, PaO2, etc.) Failure to generate an alarm signal that can be detected by a test alarm When a fault state is detected, the corresponding algorithm 4340 notifies the presence of the fault by one or more of the following signals.

[0247] Activation of audible, visual, and / or dynamic (vibration, etc.) alarms Transmission of a message to an external device Logging of incidents 5.4.4 Portable RPT Device

[0248] As illustrated in FIGS. 7 to 21, the blower 9000 is used in combination with a patient interface (or other head-mounted interface) and is described below. Further details regarding the blower are described in U.S. Patent Application No. 17 / 602,552, which is hereby incorporated by reference in its entirety. 5.4.4.1 Blower

[0249] The blower 9000 can be a device that generates a flow of pressurized air. When used in conjunction with the patient interface 3000, the blower 9000 can deliver pressurized air to the patient's airway to assist the patient's breathing. Alternatively or additionally, the blower 9000 can be used to generate an airflow at ambient pressure. Similarly, it can also be used to assist the patient's breathing. Furthermore, alternatively or additionally, the blower 9000 can be used to generate a cooling airflow (which may be pressurized or unpressurized). This can improve the comfort of the user (e.g., a patient receiving respiratory therapy and / or a person wearing other types of devices) when wearing the interface.

[0250] As illustrated in Figure 7, the blower 9000 may include a partially cylindrical shape. Specifically, the blower 9000 may include a first or left-side housing 9010 and a second or right-side housing 9020, each of which may have a substantially cylindrical shape.

[0251] In some forms, the edges of the first and / or second housings 9010, 9020 may be rounded, chamfered, or similar, so that each housing 9010, 9020 is not perfectly cylindrical.

[0252] In some configurations, the cylindrical shape of the left and right housings 9010 and 9020 may provide a smooth surface along the outer circumference. As will be discussed later, this smooth surface may be useful for connecting the blower 9000 to another element (e.g., the patient interface 3000).

[0253] Continuing to refer to Figure 7, the shape of the blower 9000 may be stepped due to the influence of the second stators 9030 and 9040 that contact the respective housings 9010 and 9020. In cross-section (e.g., Figure 10), each side of the blower 9000 (i.e., left or right) may appear substantially T-shaped, and each section (i.e., the respective housings 9010 and 9020 and the respective second stators 9030 and 9040) may be circular (e.g., cylindrical).

[0254] In certain configurations, the blower 9000 can have a substantially compact design (for example, due to the influence of the cylindrical left and right housings 9010 and 9020). The compact shape of the blower 9000 may allow it to fit into smaller spaces, which can be useful for connecting it to other elements. Furthermore, this compact design can result in a lightweight blower 9000, which can be beneficial when used in conjunction with the patient interface 3000, as will be discussed later. 5.4.4.2 Housing

[0255] As shown in Figures 8 and 9, the housings 9010 and 9020 are each substantially hollow and may include cavities 9012 and 9022 for receiving various components of the blower 9000. Each cavity 9012 and 9022 may have a shape similar to the external shape of the respective housings 9010 and 9020.

[0256] In some configurations, each housing 9010, 9020 may include an opening at either side end. For example, the left housing 9010 may include a left cavity opening 9014, and the right housing 9020 may include a right cavity opening 9024. The left and right cavity openings 9014, 9024 may each be substantially circular in shape. The diameter of each cavity opening 9014, 9024 may be similar to the outer diameter of each respective housing 9010, 9020 (for example, the thickness of each housing 9010, 9020 adjacent to each cavity opening 9014, 9024 may be relatively thin).

[0257] In some embodiments, each housing 9010, 9020 may include air inlets 9015, 9025 that are in fluid communication with their respective cavities 9012, 9022. In the illustrated embodiment, the left air inlet 9015 may be positioned at the opposite end of the left housing 9010 from the left cavity opening 9014. Thus, a flow path may exist through the left housing cavity 9012 between the left air inlet 9015 and the left cavity opening 9014. A similar flow path may exist through the right housing cavity 9022 between the right air inlet 9025 and the right cavity opening 9024.

[0258] In a particular configuration, the air inlets 9015 and 9025 on each housing 9010 and 9020 may be concentric with the respective cavity openings 9014 and 9024 such that a common axis extends through each pair of air inlets 9015 and 9025 and cavity openings 9014 and 9024.

[0259] As illustrated in Figures 10 and 11, the end faces of each housing 9010, 9020 (i.e., those adjacent to the respective air inlets 9015, 9025) may include a slope that extends from the outer edge toward the center (for example, toward the respective air inlets 9015, 9025). 5.4.4.3 Internal Housing Elements

[0260] As shown in Figure 7, the blower 9000 may further include left and right stators 9030 and 9040, left and right first impellers 9050 and 9060, and left and right second impellers 9070 and 9080. For the sake of brevity, the following description will focus only on the "left" elements, but all descriptions apply equally to the "right" elements. Furthermore, the descriptive terms "left" and "right" refer to the orientation of the figure, which may be reversed depending on the orientation of the blower 9000. 5.4.4.3.1 First Impeller

[0261] As illustrated in Figures 10 and 11, the left-side housing 9010 can at least partially accommodate the left-side first impeller 9050 and the left-side first stator 9070. In the illustrated embodiment, the left-side first impeller 9050 may be positioned close to the left-side air inlet 9015, and the left-side first stator 9070 may be positioned close to the left-side cavity opening 9014. The left-side first stator 9070 may be sandwiched between the left-side first impeller 9050 and the left-side second stator 9030 (details below).

[0262] In some configurations, the hub 9052 may be positioned close to the center of the left-side first impeller 9050. The hub 9052 may include a hub opening 9053 (e.g., a through-hole) extending through the hub 9052. Multiple blades 9054 may extend radially outward from the hub 9052 (see Figure 9).

[0263] In some embodiments, the blade 9054 may include a first blade 9054-1 and a second blade 9054-2. The first impeller 9050 may include a surface 9105 through which the hub 9052 passes. The first blade 9054-1 may be positioned on one side of the surface 9105, and the second blade 9054-2 may be positioned on the opposite side of the surface 9105. Generally, a description of the blade 9054 may refer to both the first blade 9054-1 and the second blade 9054-2.

[0264] In some configurations, the first impeller 9050 may have an equal number of first blades 9054-1 and second blades 9054-2.

[0265] In a particular configuration, the first blade 9054-1 can be rotatably positioned at substantially the same position as the second blade 9054-2. In other words, the first blade 9054-1 and the second blade 9054-2 can be aligned through the surface 9105.

[0266] As illustrated in Figures 8, 9, 12, and 13, the blades 9054 (i.e., blades 9054-1 and 9054-2) may have a linear orientation. For example, blade 9054 may extend in a straight path (e.g., linearly) between the hub 9052 and the outer circumference of the left-side first impeller 9050. Alternatively, any number of blades (e.g., blades 9054-1 and / or blades 9054-2) may extend along a curved path to form an arc-shaped blade 9054. In some embodiments, this may help provide a substantially smooth flow path to reduce turbulence and, consequently, noise.

[0267] In some embodiments shown in Figures 12 and 13, all blades 9054 may substantially extend between the hub 9052 and the outer circumference of the left impeller 9050. For example, each blade 9054 may include a length substantially equal to the radius of the surface 9105 minus the diameter of the hub 9052.

[0268] In a particular embodiment, the first impeller 9050 may include a stepped cylindrical shape such that the outer diameter of one side of the surface 9105 differs from the outer diameter of the other side of the surface 9105. For example, the diameter of the first impeller 9050 may be larger on the side facing the outside of the surface 9105 (i.e., including the first blade 9054-1) than on the side facing the inside of the surface 9105 (i.e., including the second blade 9054-2). The difference in diameter may be created by a ring 9107 extending from the inside of the surface 9105.

[0269] In one embodiment, the length of the second blade 9054-2 (or at least some of the blades 9054-2) may be substantially equal to the inner radius of the ring 9107 minus the diameter of the hub 9052. In this embodiment, the length of the first blade 9054-1 may be longer than the length of the second blade 9054-2 due to the influence of the ring 9107.

[0270] In other embodiments, at least some of the blades 9054 may extend to the outer circumference of the left impeller 9050, but not fully to the hub 6052. For example, at least some of the blades 9054 could be arranged such that every other blade 9054 is connected to the hub 9052, and each blade 9054 not connected to the hub 9052 lies between two connected blades 9054.

[0271] In yet another embodiment, some of the blades 9054 may extend from the hub 9052 and not reach the outer circumference of the left impeller 9050. In yet another embodiment, some of the blades 9054 may be spaced apart from both the hub 9052 and the outer circumference of the left impeller 9050.

[0272] In some configurations, the blades 9054 can be spaced apart from each other such that there is a substantially equal gap between each of the adjacent blades 9054.

[0273] In some configurations, the thickness of the first blade 9054-1 and / or the second blade 9054-2 may be less than approximately 0.2 mm, for example less than approximately 0.1 mm, measured, for example, at its thinnest part or at its outermost (i.e., downstream) part. Furthermore, as is specific to RPT devices, in some impeller designs, even a slight reduction in dimensions can have a favorable effect on the airflow of the left impeller 9050 and the efficiency of the RPT device.

[0274] Although not shown, some forms of the blade 9054 may include one or more serrated edges. A preferred embodiment of the arrangement of the serrated edges can be found in U.S. Patent No. 10,844,876, the entire contents of which are incorporated herein by reference.

[0275] As shown in Figure 11, at least some of the edges of blade 9054-1 and / or 9054-2 may be substantially perpendicular to the hub 9052 (e.g., without inclination). In other embodiments, at least one inner edge of a blade 9054 adjacent to the hub 9052 (e.g., blade 9054-1 and / or blade 9054-2) may be inclined with respect to the axis of the hub 9052 at an angle greater than, for example, 45 degrees.

[0276] In some embodiments, the outer surface 9051 of the impeller 9050 may have an inclined shape (e.g., in cross-sectional view) to conform to the inclined shape of the housing 9010. The outer surface 9051 may be located on the first blade 9054-1, opposite the second blade 9054-2. As shown in Figure 11, the inclination of the impeller 9050 may be substantially identical to the inclination of the housing 9010 so that the distance between the outer surface 9051 and the housing 9010 is kept substantially constant.

[0277] For ease of understanding, we will identify the “right side” elements here. The blower 9000 further includes the right side first impeller 9060, outer surface 9061, right side hub 9062, hub opening 9063, right side blade 9064, first blade 9064-1, and second blade 9064-2. The following description relating to the “left side” elements also applies to the “right side” elements. 5.4.4.3.2 First State

[0278] As shown in Figures 7 to 9, the left first stator 9070 may be positioned in close proximity to the left first impeller 9050 within the left housing 9010. In the illustrated embodiment, the left first stator 9070 may be positioned adjacent to the second blade 9054-2 of the first impeller 9050 when the blower 9000 is in use.

[0279] As shown in Figures 8, 9, and 14–17, the first stator 9070 includes an inner 9071 facing the center of the blower 9000 (e.g., toward the motor and away from the first impeller 9050). The inner 9071 includes a blade (e.g., a third blade) 9072 which may face away from the first and second blades 9054-1, 9054-2.

[0280] In some configurations, the third blade 9072 may not extend radially from the center of the first stator 9070. Instead, the third blade 9072 may extend around the outer circumference of the first stator 9070.

[0281] In a particular configuration, the first stator 9070 may include a plurality of spaced-apart third blades 9072 extending along a circumferential path. The third blades 9072 may be the widest portion of the first stator 9070.

[0282] In a particular configuration, each third blade 9072 includes an axially extending portion 9073 and a circumferentially extending portion 9074. The axially extending portion 9073 may extend along the axial direction of the third blade 9072, away from the inner portion 9071. Each axially extending portion 9073 may be positioned on the outer circumference of the inner portion 9071 to give thickness to the axially extending portion 9073, and may further extend toward the center of the first stator 9070. The circumferentially extending portion 9074 may be adjacent to the radially extending edge of the axially extending portion 9073, and may further extend along a circumferential path centered on at least a portion of the outer circumference of the first stator 9070. The outer edge of the circumferentially extending portion 9074 may extend beyond the outer edge of the inner portion 9071, thus forming the widest portion of the first stator 9070.

[0283] In one embodiment, each axially extending portion 9073 may be spaced apart from one another around the first stator 9070. Each circumferentially extending portion 9074 may be longer than the corresponding axially extending portion 9073. For example, the free end 9078 of a circumferentially extending portion may extend into an adjacent axially extending portion 9073.

[0284] In a particular configuration, the circumferentially extending portion 9074 may be at least partially inclined from the top surface of each axially extending portion 9073 to the edge of the first stator 9070. For example, the circumferentially extending portion 9074 may include a steep curve adjacent to each axially extending portion 9073 and a gentle curve adjacent to an adjacent axially extending portion 9073.

[0285] In some configurations, the circumferentially extending portion 9074 may be separated from the axially extending portion 9073. That is, the circumferentially extending portion may not substantially extend between the ends of the first stator 9070.

[0286] In some embodiments, at least a portion of the axially extending portion includes a slot 9077. The slot 9077 may extend axially through the first stator 9070. For example, the slot 9077 may extend completely through the inner 9071 to allow fluid communication through the body of the first stator 9070.

[0287] In the illustrated embodiment (see, for example, Figures 16 to 18), each slot 9077 may have a substantially rectangular shape, but other shapes may also be used. The slots 9077 may also have a slight curvature to conform to the curved shape of the portion 9073 extending in the axial direction of each.

[0288] In some embodiments, the first stator 9070 may include an opening 9075 that passes through the surface of the inner 9071. As illustrated in Figures 10 and 11, the opening 9075 may extend completely through the body of the first stator 9070.

[0289] In certain embodiments, the opening 9075 may be larger than the hub opening 9053. For example, Figure 11 shows a hub 9052 and a hub opening 9053 having a width less than the width of the opening 9075. In the illustrated embodiment, the width of the opening 9075 may be substantially narrower than the outer width of the hub 9052 (for example, such that the inner circumferences of the hub 9052 and the opening 9075 are spaced apart from each other). However, other embodiments may include a hub 9052 and an opening 9075 that are spaced close together (for example, in contact with each other).

[0290] In some embodiments, the space within the first stator 9070 may vary in width. For example, the width of the opening 9075 may not be a constant inner diameter along the length of the first stator 9070. In the illustrated embodiment, the first stator 9070 may include a larger opening 9076 compared to the opening 9075. The inner portion of the first stator 9070 is substantially hollow and may have the width of the larger opening 9076. At the opposite end of the larger opening 9076 (for example, near the axially extending portion 9073), the width may narrow to the width of the opening 9075. This may be a stepped surface where the change is rapid, but in other embodiments, the widths of the openings 9075, 9076 may change gradually.

[0291] As shown in Figures 10 and 11, the outer edge of the left first stator 9070 forms a diameter substantially similar to the outer diameter of the left impeller 9050. For example, the outer diameters of the left first stator 9070 and the left impeller 9050 may be equal.

[0292] As described above, the first impeller 9050 may include a stepped surface with a ring 9107 having a smaller diameter (e.g., compared to the diameter of the surface 9105). The length of the ring 9107 from the surface 9105 to the end of the first impeller 9050 (e.g., the edge of the second blade 9054-2) may be substantially the same as the length of the first stator 9070 from the larger opening 9076 to the opening 9075. In use, the ring 9107 of the first impeller 9050 may be positioned within the first stator 9070 through the larger opening 9076. In other words, the first impeller 9050 may be at least partially nested within the first stator 9070.

[0293] In some embodiments, the first blade 9054-1 may be positioned outside the first stator 9070. For example, the first blade 9054-1 may face away from the opening 9075 and be positioned outside the larger opening 9076. The second blade 9054-2 may face the opening 9075 and be positioned within the first stator 9070. When connected, the inner diameter of the first stator 9070 may be positioned close to the outer diameter of the ring 9107. In some embodiments, this may be a close state (e.g., not in contact), and in other embodiments, this may be a state where they are in contact and adjacent to each other. For example, the first impeller 9050 and the first stator 9070 may be connected to each other using press-fit, friction fit, and / or snap-fit.

[0294] In a particular configuration, the first blade 9054-1 and the axially extending portion 9073 may be exposed upon connection, while the second blade 9054-2 may be located within the first stator 9070 and not directly exposed upon connection.

[0295] In a particular embodiment, the hub 9052 of the first impeller 9050 may extend through the opening 9075 when the first and first stators 9050, 9070 are connected to each other. A hub opening 9053 at either end of the hub 9052 may be exposed while the first and first stators 9050, 9070 are connected to each other. In a particular embodiment, the hub 9052 may extend beyond the axially extending portion 9073, while in other embodiments, the hub 9052 may only partially extend to the length of the axially extending portion 9073.

[0296] As illustrated in Figure 11, the outer diameter of the first impeller 9050 up to the end of the first blade 9054-1 may be substantially equal to the outer diameter of the first stator 9070, excluding the width of the circumferentially extending portion 9074. The outer surface may be positioned substantially flush with the surface during use.

[0297] In some forms, the outer width of the circumferentially extending portion 9074 may be similar to the inner width of the cavity 9012 within the housing 9010. As illustrated in Figure 11, the circumferentially extending portion 9074 may extend roughly to the wall of the housing 9010 that forms at least partially the cavity 9012. A small space may exist between the wall of the housing 9010 and the circumferentially extending portion 9074, although they may also be in contact with each other.

[0298] When connected, the opening 9075 of the left first stator 9070 can be aligned with the left hub 9052 of the left impeller 9050. In other words, the centers can be aligned along a common axis. As will be described in more detail below, the common axis may be the rotor axis, through which the drive shaft extends and which may extend through both impellers 9050 and 9070.

[0299] In some configurations, the width of the opening 9075 can be made large enough so that the second blade 9054-2 is visible when viewed along the axis passing through the opening 9075 (for example, larger than the external dimensions of the hub 9052).

[0300] For ease of understanding, we will identify the “right side” elements here. The blower 9000 further includes the right side first stator 9080, the inner 9081, the third blade 9082, the axially extending portion 9083, the circumferentially extending portion 9084, the opening 9085, the larger opening 9086, and the slot 9087. The following description relating to the “left side” elements also applies to the “right side” elements. 5.4.4.3.3 Second Status

[0301] Similar to the first impellers 9050, 9060 and the first stators 9070, 9080, the blower 9000 may include a plurality of stators 9030, 9040, corresponding to each pair of impellers 9050, 9070 and impellers 9060, 9080. Figures 8 to 11 show the features of one example of a first or second left stator 9030, corresponding to the left first and first stators 9050, 9070. The second left stator 9030 may include a plurality of left stator vanes 9032 for guiding the airflow from the first and first stators 9050, 9070 along the inner surface of the second left stator 9030. In some forms, this can reduce the velocity of the airflow from the first and first stators 9050, 9070 and / or increase the pressure of the airflow from the first and first stators 9050, 9070.

[0302] In the illustrated embodiment, the left second stator 9030 can be at least partially received within the left housing 9010 together with the left first impeller 9050 and the left first stator 9070.

[0303] As described above, the left-side second stator 9030 can be positioned downstream from both the left-side first impeller 9050 and the left-side first stator 9070. In the exemplary embodiments shown in Figures 10 and 11, the left-side first impeller 9050 is positioned further upstream from both the left-side first stator 9070 and the left-side second stator 9030. However, the orientation of these three elements can be in any direction.

[0304] The left-side second stator 9030 may include a top ring 9034, a connecting ring 9036, and a plurality of left-side stator vanes 9032 arranged radially inside the top ring 9034 and the connecting ring 9036. The left-side stator vanes 9032 can guide the airflow from the first and second stators 9050, 9070 along the length of the second stator 9030.

[0305] Each of the multiple left-side stator vanes 9032 may substantially extend along the entire length of the left-side second stator 9030. The left-side stator vanes 9032 may also include a substantially helical shape. In the embodiments shown in Figures 8 to 10, each stator vane 9032 may extend for less than 360°, but in other embodiments, at least one stator vane 9032 may extend for more than 360°.

[0306] In some configurations, the left stator vanes 9032 can reduce the velocity of the airflow from the left first and first stators 9050, 9070 and / or increase the pressure of the airflow from the left first and first stators 9050. Each left stator vane 9032 may have a constant depth in the radial direction and a width W that varies in the axial direction. For example, the width W may decrease in the direction away from the top ring 9034.

[0307] Continuing to refer to Figures 10 and 11, the left second stator 9030 may include an inner wall 9038. The left stator vane 9032 may extend from the inner wall 9038. In the exemplary embodiment, the left stator vane 9032 may be integrally formed with the inner wall 9038 (for example, formed during the same molding process).

[0308] In some configurations, the inner wall 9038 is continuous between the top ring 9034 and the connecting ring 9036. For example, the wall 9038 may not include any openings or other means of inlet or outlet.

[0309] As shown in Figures 8 to 11, certain configurations of the left second stator 9030 can be hollow except for the stator vane 9032. For example, the inner wall 9038 can form the inner and outer circumference of the left second stator 9030 (e.g., across the entire thickness of the inner wall 9038), but may leave an open space within the inner wall 9038.

[0310] In some embodiments, the top ring 9034 may include a connecting ring 9036 having an opening that communicates with a hollow interior formed by the inner wall 9038. In the illustrated embodiment, the connecting ring 9036 may be positioned approximately in the center of the top ring 9034 in order to align with the hub 9052 of the first impeller 9050. That is, a common shaft may extend through the centers of the hub 9052 and the connecting ring 9036.

[0311] In some embodiments, the inner diameter of the connecting ring 9036 of the second stator 9030 may be larger than the outer diameter of the hub 9052 of the first impeller 9050. In the illustrated embodiment, the connecting ring 9036 of the second stator 9030 is connected to the outer surface of the hub 9052 of the first impeller 9050. In some embodiments, this connection may be a detachable connection (e.g., snap-fit, friction fit, press-fit, magnetic, etc.). In other embodiments, the first impeller 9050 and the second stator 9030 may be permanently connected to each other in close proximity to the hub 9052 and the connecting ring 9036. In yet another embodiment, the second stator 9030 and the first impeller 9050 may be positioned adjacent to each other but translationally movable relative to each other.

[0312] In some embodiments, the top ring 9034 may include one or more slots 9039. The slots 9039 may be substantially rectangular, but may be partially curved to conform to the shape of the top ring 9034. The slots 9039 may be spaced apart from each other with respect to the top ring 9034. In the illustrated embodiment, the slots 9039 may be radially arranged between the outer circumference of the top ring 9034 and the connecting ring 9036.

[0313] In some configurations, as shown in Figures 16 and 17, slot 9039 extends through the top ring, providing fluid communication with the interior of stator 9030 formed by its inner wall. As will be described in more detail below, slot 9039 may be aligned with slot 9077 to provide fluid communication through both the first stator 9070 and the second stator 9030.

[0314] In some configurations, the housing 9010 may contact (or be positioned in close proximity to) the top ring 9034. For example, the hub 9052 and the connecting ring 9036 may be connected to each other such that the hub 9052 is at least partially received through the connecting ring 9036. In this position, the housing 9010 and the second stator 9030 may be in close contact with each other, and the first and second stators 9050, 9070 may be mounted within the cavity 9012 and at least partially surrounded by the second stator 9030.

[0315] In some configurations, the top ring 9034 may be substantially planar. This may allow the housing 9010 to come into contact with the surface of the top ring 9034 in a substantially sealed state (for example, to restrict airflow between interfaces).

[0316] In some configurations, when the top ring 9034 is connected to the housing 9010, the opposing end 9037 of the second stator 9030 may still be exposed from the top ring 9034. The opposing end 9037 may be located at the edge of a volume at least partially formed by the inner wall 9038. The width of the opposing end 9037 may be narrower than the width of the top ring 9034.

[0317] For ease of understanding, we will identify the “right side” elements here. The blower 9000 further includes the right side stator 9040, stator vanes 9042, top ring 9044, connecting ring 9046, opposing end 9047, and inner wall 9048. The following description relating to the “left side” elements applies equally to the “right side” elements. 5.4.4.4 Use of a blower

[0318] As described above, the blower 9000 can be assembled such that its elements are at least partially located within the respective housings 9010, 9020. In some configurations, at least the left and right stators 9030, 9040 can be positioned at least partially outside the respective housings 9010, 9020. For example, the left second stator 9030 can be positioned almost entirely outside the left housing 9010, except for the connecting ring 9036.

[0319] In some configurations, the top ring 9034 may function to stop and limit further axial translational movement of the left housing 9010. In this position, the top ring 9034 may remain outside the housing 9010, so the left stator vane 9032 also remains substantially outside the housing 9010. The right housing 9020 and the right stator 9040 may be oriented similarly, so that the top ring 9044 extends from the right housing 9020.

[0320] In some configurations, the left and right sides can be connected by positioning the left opposing end 9037 close to the right opposing end 9047. As shown in Figures 10 and 11, the opposing ends 9037 and 9047 of the stators 9030 and 9040 may face each other. In some configurations, the housings 9010 and 9020 are spaced apart from each other, and the stators 9030 and 9040 are also spaced apart from each other. This spacing may generate a blower outlet 9098.

[0321] This airflow can be generated by a motor 7000 (see, for example, Figure 9). The motor 7000 has a single shaft 7005 protruding from each end and can drive the corresponding impellers 9050, 9060. In some forms, the motor 7000 may be a brushless DC motor.

[0322] As shown in Figures 8 to 10, the hollow spaces within the outer walls 9038 and 9048 of the stators 9030 and 9040 can form spaces for receiving the motor 7000. These spaces may have a substantially cylindrical shape and can correspond to the shape of the motor 7000.

[0323] As described above, the common shaft RA may extend through the center of the hub 9052 and connecting ring 9036 (and the hub 9062 and connecting ring 9046). When positioned within the space created by the inner walls 9038, 9048, the center of the motor 7000 can be aligned with shaft RA. Shaft 7005 may protrude from the motor 7000 along shaft RA so that it may extend through the hub 9052 and connecting ring 9034 (and the hub 9062 and connecting ring 9044). When power is supplied to the motor 7000, shaft 7005 rotates, which in turn rotates at least the first impellers 9050, 9060. As the first impellers 9050, 9060 rotate, an airflow is generated, as described above, which is guided along the stator vanes 9032, 9042 and discharged from the blower outlet 9098.

[0324] In some configurations, a slot 9077 of the first stator 9070 can be aligned with a slot 9039 of the second stator 9030. This can provide fluid communication from the first stator 9070 to the interior of the second stator 9030. Since the stators 9030 and 9070 cannot rotate relative to each other, the positions of the slots 9039 and 9077 remain constant relative to each other, thereby maintaining the flow paths through the slots 9039 and 9077.

[0325] In some configurations, the rotation of the first impeller 9050 can generate an airflow that can be directed toward the second stator 9030. In particular, the rotation of the second blade 9054-1 generates an airflow that passes through slots 9077, 9039 toward the second stator 9030 and is discharged to the patient through the vane 9032 and the blower outlet 9098.

[0326] In some configurations, the length of shaft 7005 can range from approximately 1 mm to approximately 200 mm. In some configurations, the length of shaft 7005 can range from approximately 2 mm to approximately 100 mm. In some configurations, the length of shaft 7005 can range from approximately 5 mm to approximately 50 mm. In some configurations, the length of shaft 7005 can range from approximately 10 mm to approximately 40 mm. In some configurations, the length of shaft 7005 can range from approximately 20 mm to approximately 30 mm. In some configurations, the length of shaft 7005 can range from approximately 22 mm.

[0327] In some configurations, the outer diameter of shaft 7005 can range from approximately 1 mm to approximately 100 mm. In some configurations, the outer diameter of shaft 7005 can range from approximately 2 mm to approximately 50 mm. In some configurations, the outer diameter of shaft 7005 can range from approximately 5 mm to approximately 30 mm. In some configurations, the outer diameter of shaft 7005 can range from approximately 10 mm to approximately 25 mm.

[0328] As shown in Figure 21, several forms of the blower 9000 can be used in conjunction with a patient interface 3000 (or other user interface worn by the user) to which the blower is mounted together with the plenum chamber 3200. For example, since the blower 9000 can be directly attached to the plenum chamber 3200, the patient can support the blower with their face rather than with a separate device.

[0329] The patient interface 3000 may include an enclosure 7050 that can enclose a blower 9000 (not shown in this figure), such as in embodiments disclosed elsewhere in this specification. The enclosure 7050 may provide sound insulation, for example, through a muffler and / or acoustic foam. The enclosure 7050 may also include an opening (not shown in this figure) that allows air to enter the enclosure 7050 and reach the motor 7000, and further allows air to be discharged from a blower outlet 9098, which may be at least partially enclosed by the enclosure 7050. The enclosure 7050 may help reduce noise to limit discomfort to the patient and / or cohabitants.

[0330] As shown in Figures 10 and 11, the blower outlet 9098 may be positioned around the outer circumference of the blower 9000. Thus, the airflow is output in multiple directions. The enclosure 7050 may help guide the air by including only a single outlet toward the plenum chamber 3200 to limit the leakage of pressurized air to the surroundings.

[0331] For use, the blower 9000 can supply pressurized breathing gas to the plenum chamber 3200 so that the patient can inhale the gas. In some forms, the blower 9000 may be controllable (e.g., by an actuator located on the patient interface 3000, by a downloaded program, and / or by a remote control device (e.g., a mobile phone or computer)). By controlling the blower 9000, the speed and / or duration of operation of the motor 7000 can be adjusted. 5.5 Air Circuit

[0332] An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and arranged to allow airflow to move between two components (e.g., an RPT device 4000 and a patient interface 3000) during use.

[0333] In detail, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs for inhalation and exhalation of the circuit. In other cases, a single limb is used.

[0334] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (for example, to maintain or raise the air temperature). The heating elements may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may communicate with a controller such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety. 5.6 Humidifier 5.6.1 Overview of Humidifiers

[0335] In one embodiment of this technology, a humidifier 5000 is provided (for example, as shown in Figure 5A) to change the absolute humidity of the air or gas delivered to the patient relative to the surrounding air. Typically, the humidifier 5000 is used to increase the absolute humidity and raise the temperature of the airflow (compared to the ambient air) before delivery to the patient's airway.

[0336] 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 embodiments, 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 adapted to house the humidifier reservoir 5110 and which may include a heating element 5240. 5.6.2 Humidifier components 5.6.2.1 Water Reservoir

[0337] In one configuration, the humidifier 5000 may include a water reservoir 5110 configured to receive or hold a certain volume of liquid (e.g., water) to evaporate in order to humidify the airflow. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide adequate humidification for at least the duration of a respiratory therapy session, such as a night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other configurations, the humidifier 5000 may be configured to receive water from an external water source (e.g., a building's water supply system).

[0338] In one embodiment, the water reservoir 5110 is configured to humidify the airflow from the RPT device 4000 as it passes through it. In one embodiment, the water reservoir 5110 may be configured to encourage the air to pass through the reservoir 5110 in a meandering path while in contact with the amount of water in the water reservoir 5110.

[0339] In one embodiment, the reservoir 5110 can be removed laterally from the humidifier 5000, for example, as shown in Figures 5A and 5B.

[0340] The reservoir 5110 may also be configured to prevent liquid from flowing out when the reservoir 5110 is displaced and / or rotated, for example, through any aperture and / or between its subcomponents, from its normal operating orientation. Since the airflow to be humidified by the humidifier 5000 is normally pressurized, the reservoir 5110 may also be configured to prevent air pressure loss due to leakage and / or flow impedance. 5.6.2.2 Conductive parts

[0341] In one configuration, the reservoir 5110 includes a conductive portion 5120 configured to enable efficient heat transfer from the heating element 5240 to a fixed volume of liquid within the reservoir 5110. In one embodiment, the conductive portion 5120 may be arranged as a plate, but other shapes may also be preferred. The conductive portion 5120, in whole or in part, may consist of a thermally conductive material such as aluminum (e.g., with a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, a suitable thermal conductivity may be achieved by a less conductive material in a suitable shape. 5.6.2.3 Humidifier reservoir dock

[0342] In one embodiment, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in Figure 5B) arranged to receive a humidifier reservoir 5110. In some configurations, the humidifier reservoir dock 5130 may include a locking mechanism, such as a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130. 5.6.2.4 Water Level Indicator

[0343] 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 can provide a user, such as a patient or caregiver, with one or more indications of the amount of water volume in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof (e.g., 25%, 50%, or 75%), or a volume (e.g., 200 ml, 300 ml, or 400 ml). 5.6.2.5 Humidifier transducer (multiple units possible)

[0344] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 in place of or in addition to the transducer 4270. As shown in Figure 5C, the humidifier transducer 5210 may include one or more of the following: an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218. The humidifier transducer 5210 may generate one or more output signals that can be communicated to a controller such as a central controller 4230 and / or a humidifier controller 5250. In some forms, the humidifier transducer may be located outside the humidifier 5000 (for example, within the air circuit 4170) while transmitting output signals to the controller. 5.6.2.5.1 Pressure Transducer

[0345] One or more pressure transducers 5212 may be provided in the humidifier 5000 in addition to, or instead of, the pressure sensors 4272 provided in the RPT device 4000. 5.6.2.5.2 Flow Transducer

[0346] One or more flow transducers 5214 may be provided in the humidifier 5000 in addition to, or instead of, the flow sensor 4274 provided in the RPT device 4000. 5.6.2.5.3 Temperature Transducer

[0347] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure the temperature of one or more (e.g., of the heating element 5240 and / or the airflow downstream of the humidifier outlet 5004). In some embodiments, the humidifier 5000 may further include a temperature sensor 5216 for detecting the temperature of the ambient air. 5.6.2.5.4 Humidity Transducer

[0348] In one embodiment, the humidifier 5000 may include one or more humidity sensors 5218 for detecting the humidity of a gas, such as ambient air. In some embodiments, the humidity sensors 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensors may be absolute humidity sensors or relative humidity sensors. 5.6.2.6 Heating elements

[0349] In some cases, a heating element 5240 may be supplied to a humidifier 5000 to provide heat input to one or more of the water volume and / or airflow in the humidifier reservoir 5110. The heating element 5240 may include a heat-generating component such as an electrically resistive heating track. One suitable example of a heating element 5240 is a layered heating element, for example, described in PCT Patent Application Publication WO2012 / 171072, which is incorporated herein by reference in its entirety.

[0350] In some configurations, as shown in Figure 5B, the heating element 5240 may be located within the humidifier base 5006, and heat may be supplied to the humidifier reservoir 5110 primarily by conduction. 5.6.2.7 Humidifier Controller

[0351] In one configuration of this technology, the humidifier 5000 may include a humidifier controller 5250, as shown in Figure 5C. In one embodiment, the humidifier controller 5250 may be part of a central controller 4230. In another embodiment, the humidifier controller 5250 may be a separate controller that can communicate with the central controller 4230.

[0352] In one embodiment, the humidifier controller 5250 may receive, for example, measurements of airflow, water in the reservoir 5110, and / or characteristics of the humidifier 5000 (e.g., temperature, humidity, pressure, and / or flow rate) as input. The humidifier controller 5250 may also be configured to execute or implement a humidifier algorithm and / or deliver one or more output signals.

[0353] As shown in Figure 5C, the humidifier controller 5250 may comprise one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 arranged to control the temperature of the heated air circuit 4171, and / or a heated element controller 5252 arranged to control the temperature of the heated element 5240. 5.7 Respiratory waveform

[0354] Figure 6A shows a typical respiratory waveform model of a human during sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow rate. Although parameter values ​​can vary, typical respiration can approximate the following values: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, peak inspiratory flow rate Qpeak 0.4 L / s, expiratory time Te 2.4 s, and peak expiratory flow rate Qpeak -0.5 L / s. The total respiratory time Ttot is approximately 4 seconds. Typically, a person breathes at a rate of approximately 15 breaths per minute (BPM), and ventilation vent is approximately 7.5 L / min. The ratio of the typical duty cycle, Ti to Ttot, is approximately 40%. 5.8 Respiratory Therapy Mode

[0355] Various modes of respiratory therapy can be implemented by the disclosed respiratory therapy systems. 5.8.1 CPAP therapy

[0356] In some implementations of pulmonary pressure therapy, the central controller 4230 sets the therapeutic pressure Pt according to the therapeutic pressure equation (1) as part of the therapy parameter determination algorithm 4329. In one such implementation, the amplitude A is equivalently zero, and therefore, throughout the entire respiratory cycle, the therapeutic pressure Pt (representing the target value to be achieved at this point by the interface pressure Pm) is the same as the base pressure P0. Such implementations are mainly grouped under the heading of CPAP therapy. In such implementations, the therapy engine module 4320 does not need to determine the phase Φ or waveform template Π(Φ).

[0357] In CPAP therapy, the base pressure P0 may be a hardcoded constant value, or a constant value manually entered into the RPT device 4000. Alternatively, the central controller 4230 can repeatedly calculate the base pressure P0 as a function of an indicator or measurement of sleep-disordered breathing, such as one or more of the following: flow limitation, apnea, hypopnea, patency, or snoring, which are returned by the corresponding algorithm in the therapy engine module 4320. This alternative therapy may be referred to as APAP therapy. 5.8.2 Two-stage therapy

[0358] In other implementations of this form of the technology, the value of amplitude 1 in equation (A) may be positive. Such an implementation is known as two-stage therapy, where, when determining the therapeutic pressure Pt using equation (1) with a positive amplitude A, the therapy parameter determination algorithm 4329 oscillates the therapeutic pressure Pt between two values ​​or levels in synchronization with the spontaneous respiratory effort of the patient. That is, based on the typical waveform template Π(Φ, t) described above, the therapy parameter determination algorithm 4329 increases the therapeutic pressure Pt to P0+A (called IPAP) at the start of inspiration or during inspiration, and decreases the therapeutic pressure Pt to base pressure P0 (called EPAP) at the start of expiration or during expiration.

[0359] In one form of two-stage therapy, IPAP is a therapeutic pressure with the same purpose as the therapeutic pressure in CPAP therapy mode, while EPAP is IPAP minus amplitude A, which has a "smaller" value (some cmH2O) and is sometimes called expiratory pressure release (EPR). This form is also called CPAP therapy with EPR and is generally considered to be more comfortable than direct CPAP therapy. In CPAP therapy with EPR, either or both IPAP and EPAP can be constant values ​​and are hardcoded or manually entered into the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate IPAP and / or EPAP when using CPAP with EPR. In this alternative example, the therapy parameter determination algorithm 4329 iteratively calculates EPAP and / or IPAP as a function of the sleep-disordered breathing index or measurement returned from each algorithm in the therapy engine module 4320. This is done similarly to the calculation of the base pressure P0 in APAP therapy described above.

[0360] In other forms of two-stage therapy, amplitude A is large enough for the RPT device 4000 to complete some or all of the patient's breathing motion. In this form, called pressure-assisted ventilation, amplitude A is called pressure assist or swing. In pressure-assisted ventilation, IPAP is base pressure P0 + pressure assist A, and EPAP is base pressure P0.

[0361] In some forms of pressure-assisted ventilation known as constant-pressure assisted ventilation, the pressure assist A is fixed at a predetermined value (e.g., 10 cmH2O). The predetermined pressure assist value is a setting of the RPT device 4000, which can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220.

[0362] In other forms of pressure-assisted ventilation therapy, widely known as servo ventilation, the therapy parameter determination algorithm 4329 takes as input the currently measured or estimated parameter of the respiratory cycle (e.g., current ventilation value Vent) and the target value of that respiratory parameter (e.g., target ventilation value Vtgt), and iteratively adjusts the parameter of equation (1) to bring the current measurement of the respiratory parameter closer to the target value. In a form of servo ventilation called adaptive servo ventilation (ASV) used to treat CSR, the respiratory parameter is ventilation, and the target ventilation value Vtgt is calculated from a typical recent ventilation Vtyp by the target ventilation determination algorithm 4328, as described above.

[0363] In some forms of servo ventilation, the therapy parameter determination algorithm 4329 applies a control method that iteratively calculates pressure assist A to bring the current measured values ​​of respiratory parameters closer to target values. One such control method is proportional-integral (PI) control. In one implementation of PI control applied to an ASV mode where the target ventilation Vtgt is set slightly smaller than a typical ventilation Vtyp, pressure assist A is iteratively calculated as follows:

[0364]

number

[0365] Other servo ventilation control methods that can be applied by the therapy parameter determination algorithm 4329 include proportional (P), proportional-difference (PD), and proportional-integral-difference (PID).

[0366] The value of pressure assist A calculated by equation (2) can be extracted within the range defined as [Amin, Amax]. In this implementation, by default, pressure assist A is at minimum pressure assist Amin until the current ventilation measurement falls below the target ventilation Vtgt. At this point, A begins to increase and returns to Amin only when vent exceeds Vtgt again.

[0367] The pressure assist limits Amin and Amax are settings of the RPT device 4000, which are set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220.

[0368] In pressure-assisted ventilation therapy mode, EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP therapy, EPAP can be a constant value and is defined or determined during titration. Such a constant EPAP can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220. This alternative is also called fixed EPAP pressure-assisted ventilation therapy. For a given patient, EPAP tidal ventilation may be performed by the clinician during a titration session using PSG for the purpose of preventing obstructive apnea, thereby maintaining airway security for pressure-assisted ventilation therapy in a similar manner to titration of the base pressure P0 in constant CPAP therapy.

[0369] Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate the base pressure P0 during pressure-assisted ventilation therapy. In such an implementation, the therapy parameter determination algorithm 4329 iteratively calculates EPAP as a function of sleep-disordered breathing indicators or measurements (e.g., one or more of flow restriction, apnea, respiratory depression, patency, and snoring) returned from each algorithm in the therapy engine module 4320. Since the continuous calculation of EPAP is analogous to the manual adjustment of EPAP by a clinician in EPAP titration, this process is also referred to as automated EPAP titration, and the therapy mode is known as automated titrated EPAP pressure-assisted ventilation therapy or automated EPAP pressure-assisted ventilation therapy. 5.8.3 High flow therapy

[0370] In other forms of respiratory therapy, the airflow pressure is not controlled as in respiratory pressure therapy. Conversely, the central controller 4230 controls the pressure generator 4140 to deliver an airflow controlled by a therapeutic or target flow rate Qtgt, where the device flow rate Qd is normally positive throughout the patient's respiratory cycle. Such forms are usually grouped under the title of flow therapy. In flow therapy, the therapeutic flow rate Qtgt may be a hardcoded constant value or a constant value manually entered into the RPT device 4000. If the therapeutic flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, this therapy is generally called high-flow therapy (HFT). Alternatively, the therapeutic flow rate may be a curve Qtgt(t) that changes according to the respiratory cycle. 5.9 Glossary

[0371] For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. Alternative definitions may apply in other forms of this technology. 5.9.1 Overview

[0372] Air: In certain forms of this technology, air may be considered to mean the atmosphere, and in other forms of this technology, air may be considered to mean any other combination of some breathable gases, such as oxygen-enriched air.

[0373] Surroundings: In certain forms of this technology, the term surroundings is considered to mean (i) outside the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0374] For example, the ambient humidity for a humidifier could be the humidity of the air directly surrounding the humidifier, such as the humidity of the room where the patient is sleeping. Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0375] In another embodiment, ambient pressure may be pressure directly surrounding the body or outside the body.

[0376] In certain contexts, ambient (e.g., acoustic) noise can be considered the background noise level of the room in which the patient is located, excluding noise generated by, for example, an RPT device, or noise originating from a mask or patient interface. Ambient noise may originate from sound sources outside the room.

[0377] Automatic positive airway pressure (APAP) therapy: This is a type of CPAP therapy that can automatically adjust the therapeutic pressure between the minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0378] Continuous positive airway pressure (CPAP) therapy is a respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing if signs of partial upper airway obstruction are not present).

[0379] Flow rate: The amount (or mass) of air discharged per unit time. Flow rate can refer to an instantaneous quantity. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, a reference to flow rate is a reference to a vector quantity (i.e., a quantity that has both magnitude and direction). The symbol Q may be assigned to flow rate. "Flow rate" may be simply written as "flow" or "airflow".

[0380] In the case of patient respiration, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle, and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air exiting the RPT device. Total flow rate Qt is the flow rate of air reaching the patient interface via the air circuit, plus any supplemental gases. Ventilation flow rate Qv is the flow rate of air exiting the ventilation unit to wash out expiratory gases. Leakage flow rate Ql is the flow rate leaking from the patient interface system, etc. Respiratory flow rate Qr is the flow rate of air received by the patient's respiratory system.

[0381] Flow therapy is a respiratory therapy that involves delivering air to the airway entrance at a controlled flow rate called therapeutic flow rate, which is typically positive throughout the patient's entire respiratory cycle.

[0382] Humidifier: The term humidifier is interpreted as a humidifying device that has a physical structure capable of supplying a therapeutically beneficial amount of water (H2O) vapor to the airflow in order to improve a patient's medical respiratory condition.

[0383] Leakage: The term "leakage" refers to an unintended airflow. In one embodiment, leakage may occur as a result of an incomplete seal between the mask and the patient's face. In another embodiment, leakage may occur in a swirling elbow.

[0384] Conducted noise (acoustics): In this document, conducted noise refers to noise transmitted to a patient via pneumatic pathways (e.g., air circuits and patient interfaces and the air within them). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0385] Radiated noise (acoustics): In this specification, radiated noise refers to noise transmitted to the patient by the surrounding air. In one embodiment, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in question in accordance with ISO 3744.

[0386] Ventilation (acoustic) noise: In this specification, ventilation noise refers to noise generated by airflow passing through any ventilation opening, such as a vent in the patient interface.

[0387] Oxygen-enriched air: Air with a higher oxygen concentration than the atmosphere (21%), such as at least approximately 50%, at least approximately 60%, at least approximately 70%, at least approximately 80%, at least approximately 90%, at least approximately 95%, at least approximately 98%, or at least approximately 99% oxygen. "Oxygen-enriched air" is sometimes abbreviated as "oxygen."

[0388] Medical oxygen: Medical oxygen refers to oxygen-enriched air with an oxygen concentration of 80% or higher.

[0389] Patient: A person, regardless of whether they have a respiratory illness or not.

[0390] Pressure: Force per unit area. Pressure is expressed as cmH2O, gf / cm². 2 It can be expressed in a variety of units, including hectopascals. 1 cmH2O is 1 g-f / cm³. 2 This is equivalent to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m³). 2 (=1 millibar to 0.001 atm). Unless otherwise specified, pressure is given in cmH2O.

[0391] The pressure at the patient interface is denoted with Pm, and the therapeutic pressure, which indicates the target value to be achieved at the current interface pressure Pm, is denoted with Pt.

[0392] Respiratory pressure therapy: This involves supplying air to the airway opening at a therapeutic pressure that is usually positive relative to atmospheric pressure.

[0393] Ventilator: A mechanical device that provides pressure assistance to a patient to perform some or all of the breathing function. 5.9.1.1 Materials and their properties

[0394] Durometer hardness (indentation hardness): A material property measured by indentation (measured according to ASTM D2240). The term may refer to durometer hardness or indentation hardness (a material property measured by indentation (e.g., measured according to ASTM D2240)). • The "soft" material may include silicone or thermoplastic elastomer (TPE), which can be easily deformed, for example, under finger pressure.

[0395] "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0396] Silicone or silicone elastomer: synthetic rubber. In this specification, silicone refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products marketed under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness ranging from approximately 35 to approximately 45.

[0397] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate. 5.9.1.2 Mechanics

[0398] shaft: Neutral axis: The axis of a cross-section of a beam or plate where there is no stress or strain in the longitudinal direction.

[0399] Vertical axis: An axis that extends along the length of a figure. Generally, the axis passes through the center of the figure.

[0400] Circumferential axis: An axis perpendicular to the vertical axis. The axis may exist in particular in pipes, tubes, cylinders, or similar shapes having a circular and / or elliptical cross-section.

[0401] Deformation: The process by which the original shape of a member (structure or component) changes when a force, such as a force applied in the direction of an axis, is applied. This process may include stretching or compression, bending, and twisting.

[0402] Elasticity: The ability of a material to return to its original shape after deformation.

[0403] Floppy structure or component: A structure or component whose shape changes (e.g., curves) within a relatively short period of time (e.g., 1 second) when it is able to support its own weight.

[0404] Elasticity: The ability of a material to absorb energy during elastic deformation and release energy when the load is released.

[0405] Elasticity: When unloaded, virtually all energy is released. This includes, for example, certain silicon and thermoplastic elastomers.

[0406] Rigid structure or component: A structure or component whose shape does not substantially change when subjected to loads typically encountered during use. In one embodiment of such use, for example, a patient interface can be installed and maintained in a sealing relationship with an entry point into the patient's airway at a load pressure of approximately 20–302 cmH2O.

[0407] In one embodiment, an I-beam may have different bending stiffness (resistance to bending load) in the first direction compared to a second orthogonal direction. In another embodiment, a structure or component may be flexible in the first direction and rigid in the second direction.

[0408] Stiffness: The ability of a structure or component to resist deformation in response to an applied load. Structures and components may have axial stiffness, bending stiffness, and torsional stiffness. A structure or component is said to be rigid if it is difficult to deform under mechanical force. The stiffness of a structure or component is related to its material properties and shape. The opposite of stiffness is flexibility.

[0409] Viscosity: The ability of a material to resist flow.

[0410] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0411] Yield: The condition in which a material cannot return to its original shape after deformation. 5.9.1.3 Structural elements

[0412] Compression member: A structural element that is subjected to compressive force.

[0413] Elbow: An elbow is an example of a structure that guides the axis of airflow to change direction at an angle. In one embodiment, the angle may be approximately 90 degrees. In another embodiment, the angle may be greater than or less than 90 degrees. An elbow may have a substantially circular cross-section. In another embodiment, an elbow may have an elliptical or rectangular cross-section. In a particular embodiment, an elbow may be rotatable, for example, about 360 degrees relative to a meshing component. In a particular embodiment, an elbow may be detachable from a meshing component, for example, via a snap connection. In a particular embodiment, an elbow may be assembled to a meshing component via a one-time snap during manufacturing, but cannot be detached.

[0414] Frame: A frame is a mask structure that receives tensile loads between two or more connection points with the headgear. The mask frame can be an airtight load-bearing structure within the mask. However, some forms of mask frames can be airtight.

[0415] Load transmission member: A structural member that transmits a load from one position to another (member) (transmitting the load along the longitudinal axis).

[0416] Load-bearing member: A structural member that transmits a load from a certain point to a non-structural object such as a face.

[0417] Membrane: A membrane is preferably interpreted as a typically thin element that has virtually no resistance to bending but does have resistance to stretching.

[0418] Thai (noun): A structure designed to withstand tension.

[0419] Tension member: A structural element (member) that is subjected to tensile force.

[0420] Thin structure: beam: In a beam, one dimension may be relatively long compared to the other two dimensions, in which case the smaller dimension will be relatively thin compared to the longer dimension.

[0421] membrane It is relatively long in two dimensions, with one dimension being thin. It deforms easily in response to bending forces. It resists stretching (and may also resist compression).

[0422] Plates and shells These may be relatively long in two directions and narrower in one direction. They may have bending, tensile, and / or compressive stiffness.

[0423] Thick structure: solid Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to its effect. Two elements can be constructed and / or arranged to "seal" each other or produce a "sealing" effect without requiring a separate "seal" element of their own.

[0424] Shell: A shell is understood as a relatively thin, curved structure with bending, tensile, and compressive rigidity. For example, the curved structural walls of a mask can 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.

[0425] Stiffener: A stiffener can be understood as a structural component designed to increase the bending resistance of another component in at least one direction.

[0426] Support: A support can be understood as a structural component designed to increase the compressive strength of another component in at least one direction.

[0427] Swivel section (noun): A subassembly of components configured to rotate preferably independently around a common axis, preferably under low torque. In another embodiment, the swivel section may be configured to rotate at an angle of 360 degrees or more. In another embodiment, the swivel section may be configured to rotate at an angle of less than 360 degrees. When used in connection with an air delivery conduit, the subassembly of components preferably includes a matched pair of cylindrical conduits. During use, there may be little to no leakage of airflow from the swivel section. 5.9.2 Respiratory cycle

[0428] Apnea: According to some definitions, apnea is said to occur when airflow falls below a certain threshold for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's exertion. Central apnea is said to refer to a condition in which apnea is detected due to decreased or absent respiratory effort, even though the airway remains open. Mixed apnea is said to refer to a condition in which decreased or absent respiratory effort occurs simultaneously with airway obstruction.

[0429] Respiratory rate: This is the rate of a patient's spontaneous breathing, usually measured as respiratory rate per minute.

[0430] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0431] Effort (breathing): This refers to the effort a person puts into breathing, which is a voluntary action.

[0432] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0433] Flow restriction: Flow restriction is considered a situation in a patient's respiration where an increase in the patient's exertion does not result in a corresponding increase in flow. If flow restriction occurs in the inspiratory portion of the respiratory cycle, it can be called inspiratory flow restriction. If flow restriction occurs in the expiratory portion of the respiratory cycle, it can be described as expiratory flow restriction.

[0434] Types of flow-restricted intake waveforms: (i) Flat pattern: An upward trend continues, followed by a relatively flat period, and then a downward trend follows.

[0435] (ii) M-shaped: It has a total of two local peaks, one on the leading edge and one on the trailing edge, with a relatively flat section between these two peaks.

[0436] (iii) Chair shape: It has a single local peak, which is located on the leading edge and is followed by a relatively flat section.

[0437] (iv) Reverse chair shape: A relatively flat area is followed by a single local peak, which is located on the trailing edge.

[0438] Hypopnea: According to some definitions, hypopnea is a decrease in flow, but not a complete cessation of flow. In one form, hypopnea is said to occur when a decrease in flow below the threshold velocity persists for an extended period. When hypopnea is detected due to a decrease in respiratory effort, it is said to occur as central hypopnea. In one form in adults, hypopnea may be considered to occur if any of the following occurs:

[0439] (i) A 30% reduction in patient respiration for at least 10 seconds, and associated 4% desaturation, or (ii) A decrease in patient respiration for at least 10 seconds (but less than 50%), and associated desaturation or excitation of at least 3%.

[0440] Hyperventilation: An increase in blood flow to a higher level than normal.

[0441] The inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0442] Airway patency: This refers to the degree or extent to which the airway is open. A patent airway is open. Airway patency can be quantified; for example, a value of 1 indicates a patient, and a value of 0 indicates obstruction (obstructive state).

[0443] Positive end-expiratory pressure (PEEP): This is the pressure in the lungs at the end of exhalation that is greater than the atmospheric pressure.

[0444] Peak flow rate (Qpeak): The maximum flow rate value at the inspiratory portion of the respiratory flow waveform.

[0445] Respiratory flow rate, patient airflow rate, respiratory flow rate (Qr): These terms may be understood to refer to the estimated respiratory flow rate by an RPT device, whereas "true respiratory flow rate" refers to the respiratory flow rate actually experienced by the patient, usually expressed in liters per minute.

[0446] Tidal volume (Vt): This is the amount of air inhaled or exhaled during normal breathing without extra effort. In principle, since inspiratory volume Vi (amount of air inhaled) is equal to expiratory volume Ve (amount of air exhaled), a single tidal volume Vt can be defined as being equal to either of these amounts. In practice, tidal volume Vt is estimated as some combination (for example, the average of inspiratory volume Vi and expiratory volume Ve).

[0447] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0448] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0449] 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.

[0450] Typical recent ventilation: Ventilation values ​​where recent ventilation values ​​tend to cluster together over a given time scale (i.e., the degree of clustering of recent ventilation values).

[0451] Upper airway obstruction (UAO): Includes partial and complete upper airway obstruction. May be associated with flow-limiting conditions in which flow rate may slightly increase or decrease with increasing pressure difference across the upper airway (Stirling register behavior).

[0452] Vent: A measure of the flow rate of gases exchanged by a patient's respiratory system. Ventilation measurements may include either or both inspiratory and expiratory flow rates per unit time. When expressed as volume per minute, this amount is often called "minute ventilation." Minute ventilation may also simply be given as volume and understood as volume per minute. 5.9.3 Ventilation

[0453] Adaptive Servoventilator (ASV): A servoventilator with a variable target ventilation rather than a fixed target ventilation. The variable target ventilation can be learned from certain patient characteristics, such as the patient's respiratory characteristics.

[0454] Backup rate: A ventilator parameter that sets the minimum number of breaths (typically breaths per minute) that the ventilator provides to the patient when not triggered by spontaneous respiratory effort.

[0455] Cycled: This marks the end of the inspiratory phase of a ventilator. When a ventilator delivers breath to a patient who is breathing spontaneously, the ventilator is said to be cycled when it stops delivering breath at the end of the inspiratory portion of the respiratory cycle.

[0456] Positive expiratory airway pressure (EPAP): This is the base pressure that generates the desired interface pressure that the ventilator attempts to achieve in a given time, through the application of varying pressures during respiration.

[0457] End-Expiratory Pressure (EEP): This is the desired interface pressure that the ventilator attempts to achieve at the end of the exhalation portion of the breath. When the pressure waveform template Π(Φ) is zero at the end of exhalation, i.e., when Φ=1, Π(Φ)=0, then EEP is equal to EPAP.

[0458] Positive Inspiratory Airway Pressure (IPAP): This is the maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of breathing.

[0459] Pressure support: A numerical value indicating that the ventilator's intake pressure is higher than its expiratory pressure, generally representing the pressure difference between the maximum intake pressure and the base pressure (e.g., PS = IPAP - EPAP). In some situations, pressure support refers to the difference the ventilator attempts to achieve, rather than the difference it actually achieves.

[0460] A servo ventilator is a ventilator that measures patient ventilation, has a target ventilation level, and adjusts the level of pressure support to direct patient ventilation toward the target ventilation.

[0461] Spontaneous / Timed (S / T): This is a mode of a ventilator or other device that attempts to detect the start of breathing in a patient who is breathing spontaneously. If the device does not detect breathing within a predetermined period, the device automatically starts delivering air.

[0462] Swing: This term is equivalent to pressure support.

[0463] Trigger: A trigger is when a ventilator or other respiratory therapy device (such as an RPT device or portable oxygen concentrator) delivers a certain amount of breathable gas to a spontaneously breathing patient. Due to the patient's efforts, triggers usually occur at or near the start of the respiratory portion of the respiratory cycle. 5.9.4 Anatomy 5.9.4.1 Facial Anatomy

[0464] Alar: The outer wall of each nostril or "wing" (plural: alar) Wing angle: The angle formed between the wings of each nostril.

[0465] Outermost point of the nasal ala: The outermost point of the nasal ala.

[0466] Alar bend (or ala apex) point: The last point on the baseline of the bend of each ala, located within the fold formed by the junction of the ala and cheek.

[0467] Auricle: The entire part of the ear that is visible from the outside.

[0468] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0469] (Nasal) cartilage skeleton: The cartilage skeleton of the nose includes the nasal septum cartilage, lateral nasal cartilage, greater nasal cartilage, and lesser nasal cartilage.

[0470] Columella: A strip of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0471] Columella angle: The angle between a line drawn through the midpoint of the nostril opening and a line drawn perpendicular to the Frankfort horizontal plane, intersecting the area below the nose.

[0472] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point of the depression above the tragus of the atrial appendage.

[0473] Nasal root: Located on soft tissue, it is the point where the midline sagittal plane of the forehead protrudes the most.

[0474] Lateral nasal cartilage: This is a cartilaginous plate that usually has a triangular shape. Its upper edge connects to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the cartilage of the large nasal ala.

[0475] Lower lip (lower lip dot): The lip that extends between the nose and the mouth.

[0476] Upper lip (upper lip point): The lip that extends between the mouth and the nasal alar cartilage.

[0477] Greater alar cartilage: A plate of cartilage located beneath the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the premaxillary process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar cartilage.

[0478] Nostrils: The nearly elongated oval openings that form the entrance to the nasal cavity. The singular form of nostril is nostril. The nostrils are separated by the nasal septum.

[0479] Nasolabial folds or laugh lines: Wrinkles or grooves of skin that extend from both sides of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0480] Nasolabial angle: The angle between the columella and the upper lip, where it intersects with the area below the nose.

[0481] Infraauricular point: The lowest point where the auricle attaches to the facial skin.

[0482] Superior basement point: The highest point where the auricle meets the skin of the face.

[0483] Nasal tip: The most prominent point or tip of the nose, which can be identified by viewing it from the side of the rest of the head.

[0484] Philtrum: The groove along the midline of the upper lip, extending from the lower edge of the nasal septum to the upper part of the lip.

[0485] Mental point: A point located in the soft tissue at the very front center of the jaw.

[0486] Nasal ridge: The nasal ridge is a projection along the midline of the nose, extending from the alae of the nose to the tip of the nose.

[0487] Sagittal plane: The vertical plane from front (forward) to back (backward). The mesosagittal plane is the sagittal plane that divides the body into left and right halves.

[0488] Nasal root point: The most indented point located on soft tissue, covering the frontonasal suture region.

[0489] Nasal septal cartilage (nose): The nasal septal cartilage forms part of the nasal septum and separates the anterior part of the nasal cavity.

[0490] Lowest point of the nasal ala: The point on the lower edge of the nasal ala, where the base of the nasal ala meets the skin of the upper lip.

[0491] Infranasal point: Located on soft tissue, this is the point where the columella connects to the upper lip in the midline sagittal plane.

[0492] Splamenton: The largest depression in the midline of the lower lip, between the lower lip and the soft tissue process. 5.9.4.2 Skull Anatomy

[0493] Frontal bone: The frontal bone contains a large vertical section called the frontal squamous region, which corresponds to the area known as the forehead.

[0494] Mandible: The mandible forms the lower jaw. The mental protuberance is a protrusion on the jawbone that forms the jaw.

[0495] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbit. The frontal process of the maxilla projects upward on the side of the nose and forms part of its lateral boundary.

[0496] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from individual to individual. They are positioned side by side in the upper center of the face, and their joint forms the "beam" of the nose.

[0497] Nasal root point: The indented area where the frontal bone and the two nasal bones intersect, located between the eyes and just above the bridge of the nose.

[0498] Occipital bone: The occipital bone is located at the back and base of the skull. The skull has an oval-shaped opening called the foramen magnum, through which the cranial cavity and the spinal canal are connected. The curved plate behind the foramen magnum is the occipital squama.

[0499] Orbit: The cavity in the skull that houses the eyeball.

[0500] Parietal bone: The parietal bones are connected bones that, when fused together, form the top and sides of the skull.

[0501] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the temples of the face.

[0502] Cheekbones: The face contains two cheekbones, located on the upper and sides of the face, forming the cheek protrusions. 5.9.4.3 Anatomy of the Respiratory System

[0503] Diaphragm: A sheet of muscle that spans the bottom of the thoracic cavity. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases, and air is drawn into the lungs.

[0504] Larynx: The larynx, or vocal organ, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0505] Lungs: The human respiratory system. The conduction zone of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes respiratory bronchioles, alveolar ducts, and alveoli.

[0506] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space located 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 either side of the nasal cavity are three horizontal projections called the nasal conchae (singular "concha") or nasal turbinates. The nose is located anterior to the nasal cavity, and it connects posteriorly to the nasopharynx via the nostrils.

[0507] The pharynx is the part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is usually divided into three parts: the nasopharynx (the nasal part of the pharynx), the mesopharynx (the oral part of the pharynx), and the hypopharynx. 5.9.5 Patient Interface

[0508] Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of a patient rebreathing carbon monoxide (CO2) by releasing into the atmosphere in a fail-safe manner.

[0509] Headgear: Headgear can be understood as a form of positioning and stabilizing structure designed to hold devices such as masks on the head.

[0510] Plenum Chamber: The mask plenum chamber is understood as part of the patient interface having a wall that at least partially closes off a spatial volume of air that is pressurized to a pressure higher than atmospheric pressure when in use. The shell can form part of the mask plenum chamber wall.

[0511] Ventilation section (noun): A structure that allows airflow from inside the mask or conduit to the surrounding air, clinically effective in washing out exhaled gases. For example, in clinically effective washout, flow rates of approximately 10 liters / minute to 100 liters / minute may be used, depending on the mask design and treatment pressure. 5.9.6 Structure Shape

[0512] Products relating to this technology may include one or more three-dimensional mechanical structures, such as mask cushions or impellers. The three-dimensional structure may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, position, function, or any other characteristic of the related surfaces. For example, the structure may include one or more of a front, back, inner, and outer surface. In another embodiment, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In yet another example, the structure may include a first surface and a second surface.

[0513] To facilitate the description of the three-dimensional structure and surface shape, the inventors first consider a cross-section of the structure's surface at point p. Referring to Figures 3B to 3F, examples of cross-sections at point p on the surface and the resulting planar curves are shown. Figures 3B to 3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some embodiments, the inventors describe the surface from the perspective of a hypothetical small person standing upright on the surface. 5.9.6.1 Curvature in one dimension

[0514] The curvature of a plane curve at p can be described as having a sign (e.g., positive, negative) and magnitude (e.g., 1 / (radius of the circle exactly tangent to the curve at p)).

[0515] Positive curvature: If a curve at point p curves towards its outer normal, the curvature at that point is considered positive (if a hypothetical small person leaves 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 generally called concave curves.

[0516] Zero curvature: If the curve at point p is a straight line, the curvature is considered zero (if a hypothetical small person leaves point p, they can walk horizontally without going up or down). See Figure 3D.

[0517] Negative curvature: If the curve at point p deviates from its outer normal, the curvature at that point in that direction is considered negative (if a hypothetical small person leaves 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 generally called convex curves. 5.9.6.2 Curvature of a two-dimensional surface

[0518] The description of the shape at a given point on a two-dimensional surface according to this technology may include multiple normal cross-sections. These cross-sections may cut the surface in a plane containing an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross-section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same or different signs. Each curvature at that point may have, for example, a relatively small magnitude. The planar curves in Figures 3B to 3F may be examples of such multiple cross-sections at a particular point.

[0519] Principal curvature and direction: The direction of the normal plane in which the curvature of a curve takes its maximum and minimum values ​​is called the principal direction. In the example in Figures 3B to 3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F; therefore, Figures 3B and 3F are cross-sections in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0520] A surface region: A series of connected points on a surface. A set of points within a region may have similar properties, such as curvature or sign.

[0521] Saddle region: A region where the principal curvatures have opposite signs at each point (i.e., one is positive and the other is negative) (depending on the direction a fictional character is facing, they may be walking uphill or downhill).

[0522] Dome region: A region where the principal curvatures at each point have the same sign, for example, both are positive ("concave dome") or negative ("convex dome").

[0523] Cylindrical region: A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0524] Planar region: A region of a surface where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0525] Surface edge: The boundary or limit of a surface or area.

[0526] Path: In certain forms of this technology, “path” is understood 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 this technology, “path” can be described, for example, as a route or course containing a set of points on a surface. (For a fictional character, a path is where they walk on the surface, likened to a path in a garden).

[0527] Path length: In certain forms of this technology, "path length" refers to the distance along the surface from f(0) to f(1), i.e., the distance along the path on the surface. Multiple paths may exist between two points on a given surface, and each of these paths may have a different path length. (The path length of a fictional character would be the distance they would need to walk along the surface along that path.)

[0528] Straight-line distance: Straight-line distance is the distance between two points on a surface, regardless of the surface itself. In a planar region, there should be a path on the surface whose path length is equal to the straight-line distance between two points. On a non-planar surface, there may not be a path whose path length is equal to the straight-line distance between two points. (For a hypothetical person, straight-line distance corresponds to the distance a crow flies). 5.9.6.3 Space curve

[0529] Spatial curves: Unlike plane curves, spatial curves do not necessarily lie on a specific plane. Spatial curves can be closed; that is, they have no endpoint. Spatial curves can be considered as one-dimensional elements of three-dimensional space. A hypothetical person walking along a DNA helix walks along a spatial curve. A typical human left ear contains left-hand twist (see Figure 3Q). A typical human right ear contains right-hand twist (see Figure 3R). Figure 3S shows a right-hand twist. The edges of structures (e.g., the edges of a membrane or impeller) can follow a spatial curve. In general, a spatial curve can be described by its curvature and twist at each point on the curve. Twist is a measure of the nature of a curve originating from a plane. Twist has a sign and magnitude. The twist at a point on a spatial curve can be characterized by referring to the tangent, normal, and binormal vectors at that point.

[0530] 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 person flies along a curve and falls from a car at a specific point, the direction of the tangent vector will be the direction in which the person is moving.

[0531] Unit Normal Vector: When a fictional character moves along a curve, the tangent vector itself also changes. The unit vector that points in the same direction as the changing tangent vector is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0532] Binormal Unit Vector: The binormal unit vector is perpendicular to 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 (see Figure 3O).

[0533] Contact plane: A plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0534] Twist of a spatial curve: The twist of a spatial curve at a given point is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation of the curve from the tangent plane. A spatial curve lying in a plane has zero twist. If the deviation of the spatial curve from the tangent plane is relatively small, the magnitude of the twist of the spatial curve is relatively small (e.g., a gently sloping helical path). If the deviation of the spatial curve from the tangent plane is relatively large, the magnitude of the twist of the spatial curve is also relatively large (e.g., a steeply sloping helical path). Referring to Figure 3S, since T2 > T1, the amount of twist near the top coil of the helical S in Figure 3 is greater than the amount of twist of the lower coil of the helical in Figure 3S.

[0535] Referring to the right-hand rule in Figure 3P, a spatial curve curving toward the direction of the right-hand binormal can be considered to have a positive right-hand twist (e.g., a right-hand twist as shown in Figure 3S). A spatial curve pointing away from the direction of the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand twist).

[0536] Similarly, referring to the left-hand rule (see Figure 3O), a spatial curve pointing in the direction of the left-hand binormal can be considered to have a positive left-hand twist (e.g., a left-handed twist). Thus, the positive direction of the left hand corresponds to the negative direction of the right hand. See Figure 3T. 5.9.6.4 Hole

[0537] A surface may have one-dimensional pores (e.g., pores bounded by planar or spatial curves). A thin-walled structure with pores (e.g., a membrane) can be described as having one-dimensional pores. See, for example, the way in which one-dimensional pores in the surface of the structure shown in Figure 3I are bounded by planar curves.

[0538] The structure may have two-dimensional holes (e.g., holes bounded by a surface). For example, an inflatable tire has two-dimensional holes bounded by the inner surface of the tire. In another embodiment, a bladder containing a cavity for air or gel may have two-dimensional holes. See, for example, the cushion in Figure 3L and the exemplary cross-section of Figure 3L in Figures 3M and 3N, where the inner surface bounding the two-dimensional holes is shown. In yet another embodiment, a conduit may include one-dimensional holes (e.g., at its inlet or outlet) and two-dimensional holes bounded by the inner surface of the conduit. See also the two-dimensional holes bounded by a surface through the structure shown in Figure 3K, as illustrated. 5.10 Other remarks

[0539] Some of the disclosures in this patent document are protected by copyright. The copyright holder retains all copyright to any copies made by anyone in this patent document or disclosure, except for those intended for inclusion in the patent files or records of the Japan Patent Office.

[0540] Unless otherwise explicitly indicated by the context, if a range of values ​​is provided, it is understood that each intervening value up to one-tenth of the lower limit unit between the upper and lower limits of that range, and any other stated values ​​or intervening values ​​within that range, are included in this technique. Even if the upper and lower limits of these intervention ranges, independently included within the intervention range, specifically exceed the limits in the stated range, they are also included in this technique. If the stated range includes one or both of these limits, the range exceeding one or both of these stated limits is also included in this technique.

[0541] Furthermore, where one or more values ​​are described herein as being implemented as part of the Technology, unless otherwise stated, such values ​​may be approximations and may be used with any appropriate significant figures to the extent that a practical technical implementation may permit or require it.

[0542] Furthermore, as used herein, the terms “approximately,” “substantial,” “about,” or similar terms mean ±5 to 10% of the value mentioned.

[0543] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this art, but only a limited number of exemplary methods and materials are described herein.

[0544] While certain materials are described as suitably used for constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are understood to be manufacturable and therefore can be manufactured collectively or individually.

[0545] 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 indicates otherwise.

[0546] All published documents cited herein are used for disclosure and description and reference to the methods and / or materials covered by those documents. The published documents cited herein are provided solely for their disclosures prior to the filing date of this application. Nothing in this specification should be construed as acknowledging or acknowledging that the present technology is not prior to such published documents for the purpose of prior patents. Furthermore, the dates of the cited published documents may differ from the actual publication dates and may require individual verification.

[0547] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the elements, components, or steps described may exist, be used, or be combined with other elements, components, or steps not explicitly stated.

[0548] The headings used in the detailed descriptions are for the convenience of the reader and should not be used to limit the content found in this disclosure or the claims as a whole. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0549] While the techniques described herein have been referred to with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may indicate specific details that are not necessary for carrying out the techniques. For example, the terms “first” and “second” are used, but unless otherwise specified, these terms are not intended to indicate any arbitrary order and are used to distinguish separate elements. Furthermore, while the descriptions or examples of process steps in the methods may be given in order, such order is not required. Those skilled in the art will recognize that such order is changeable and / or that such actions can be performed simultaneously or even synchronously.

[0550] Therefore, it should be understood that many modifications can be made to the exemplary examples, and other configurations can be designed without deviating from the spirit and scope of the technology. [Explanation of symbols]

[0551] 1000 patients 1100 Bedmate 3000 Patient Interfaces 3100 Seal-forming structure 3200 Plenum Chamber 3210 Tendon 3220 Top 3230 Lower point 3300 Positioning and stabilization structure 3400 Ventilation Unit 3600 connection ports 3700 Amount Support 4000 RPT devices 4010 External Housing 4012 Top 4014 part 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet air filter 4114 Outlet air filter 4120 Muffler 4122 Entrance muffler 4124 Exhaust muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4171 Air Circuit 4180 Auxiliary gas 4200 Electrical Components 4202 Single Printed Circuit Board Assembly (PCBA) 4210 Power supply 4220 Input Devices 4230 Central Controller 4270 Transducer 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Reservoir 5120 Conduction part 5130 Humidifier Reservoir Dock 5135 Locking Lever 5150 Water Level Indicator 5240 heating element 7000 motor 7005 Shaft 7050 Enclosure 9000 Blower 9010 Left side housing 9012 Left side cavity 9014 Left side cavity opening 9015 Left side air inlet 9020 Right side housing 9022 Right side cavity 9024 Right side cavity opening 9025 Right-side air inlet 9030 Left side stator 9032 State vane 9034 Top ring 9036 Connecting Ring 9037 Opposite end 9038 Interior wall 9039 slots 9040 Right-side stator 9042 Stator vane 9044 Top ring 9046 Connecting Ring 9047 Opposite end 9048 Interior wall 9049 slots 9050 Left side impeller 9051 Outer surface 9052 Left hub 9053 Hub opening 9054 Left-side blade 9054-1 First Blade 9054-2 Second Blade 9060 Right-side impeller 9061 Outer surface 9062 Right hub 9063 Hub opening 9064 Right-side blade 9064-1 First Blade 9064-2 Second Blade 9070 Left side first stator 9071 Inside 9072 The Third Blade 9073 Axial portion 9074 Parts extending in the circumferential direction 9075 Opening 9076 Opening 9077 Slot 9078 Free end 9080 Right-side first stator 9081 Inside 9082 The Third Blade 9083 Part extending in the axial direction 9084 Parts extending in the circumferential direction 9085 Opening 9086 Opening 9087 slot 9088 Free end 9098 Blower outlet 9105 Surface 9107 Ring

Claims

1. A blower for a PRT therapy system, wherein the blower is Motor and, The motor shaft driven by the aforementioned motor, A first impeller connected to the first side of the motor shaft, the first impeller is A first wall having a first surface and a second surface facing the first surface, A plurality of first blades extending from the first surface, and A first impeller including a plurality of second blades extending from the second surface in the opposite direction to the plurality of first blades, A first stator connected to the first side of the motor shaft and arranged in series with the first impeller, wherein the first stator is A second wall, including an outer surface and an inner surface, which at least partially forms a cavity. A plurality of third blades extending from the outer surface, and A first stator including at least one first slot extending at least partially through at least one of the plurality of third blades, The cavity is configured to at least partially receive the first impeller, A blower in which the airflow generated by the first impeller is configured to pass through the at least one first slot.

2. The blower according to claim 1, wherein when the first impeller is positioned within the cavity, the plurality of second blades are positioned within the cavity.

3. The blower according to claim 1 or 2, wherein the plurality of first blades are substantially straight.

4. The blower according to any one of claims 1 to 3, wherein the second blade is substantially straight.

5. The blower according to any one of claims 1 to 4, wherein each of the plurality of first blades is substantially aligned with one of the plurality of second blades along the axial direction of the first impeller.

6. The blower according to any one of claims 1 to 5, wherein the length of each of the plurality of first blades is different from the length of each of the plurality of second blades.

7. The blower according to claim 6, wherein the length of each first blade is greater than the length of each second blade.

8. The blower according to any one of claims 1 to 7, wherein the first wall of the first impeller has a first outer diameter, and the ring extends from the second surface of the first wall and includes a second outer diameter.

9. The blower according to claim 8, wherein the first outer diameter is larger than the second outer diameter.

10. The blower according to any one of claims 1 to 9, wherein the first impeller hub extends through the first wall.

11. The blower according to claim 10, wherein the first impeller hub extends further in the opposite direction to the plurality of second blades.

12. The blower according to any one of claims 1 to 11, wherein the plurality of third blades include a plurality of axially extending portions and a plurality of circumferentially extending portions.

13. The blower according to claim 12, wherein the plurality of axially extending portions are spaced apart from each other.

14. The blower according to claim 13, wherein each circumferentially extending portion of the plurality of circumferentially extending portions extends between adjacent axially extending portions of the plurality of axially extending portions.

15. The blower according to claim 14, wherein each portion extending in the circumferential direction is in contact with one of the portions extending in the axial direction and is spaced apart from adjacent portions extending in the axial direction.

16. The blower according to claim 14, wherein the portions extending in each circumferential direction are spaced apart from the portions extending in each axial direction between them.

17. The blower according to any one of claims 12 to 16, wherein the plurality of circumferentially extending portions are located on the outer wall.

18. The blower according to any one of claims 1 to 17, wherein the hub extends in the opposite direction beyond the portion extending in the axial direction.

19. Furthermore, the blower according to any one of claims 1 to 18, further comprising a housing for receiving the first impeller and the first stator.

20. The blower according to claim 19, wherein the housing includes an opening configured to function as an inlet, the opening exposing at least a portion of the plurality of first blades.

21. The blower according to any one of claims 1 to 20, further comprising a stator having a plurality of fourth blades configured to maintain a stationary state while the motor shaft is rotating.

22. The blower according to claim 21, wherein the fourth blade is located on the inner surface of the stator.

23. The blower according to any one of claims 21 to 22, wherein each of the fourth blades has a different length.

24. The blower according to any one of claims 21 to 23, wherein the stator includes a connecting ring configured to connect to the hub.

25. The blower according to claim 24, wherein the connecting ring and the hub are connected by a snap fit.

26. The blower according to any one of claims 21 to 25, wherein the stator is in contact with the housing and surrounds the first impeller and the first stator.

27. The blower according to any one of claims 21 to 26, wherein the stator includes at least one second slot extending into the hollow interior of the stator, the at least one second slot configured to provide fluid communication to the fourth blade.

28. The blower according to claim 27, wherein the at least one first slot is aligned with the at least one second slot to form a flow path.

29. The blower according to any one of claims 1 to 28, wherein the first impeller is a left-side first impeller, the first stator is a left-side first stator, and the blower further includes a right-side first impeller and a right-side first stator.

30. A user interface configured to be worn by a user, wherein the user interface is The blower according to any one of claims 1 to 29, A seal-forming structure configured to form a seal on the user's face, A headgear connected to the seal-forming structure and configured to maintain the seal-forming structure in a sealed position on the user's face, A user interface comprising a blower housing that supports the blower and is configured to direct airflow toward the user, the blower housing being connected to the seal-forming structure for supplying airflow to the user.

31. The user interface according to claim 30, wherein the blower is a patient interface for treating sleep-disordered breathing.

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