Patient interface

Abstract

A patient interface comprising one or more electronic components for monitoring, diagnosing, and / or treating a patient, the one or more electronic components disposed in or on one or more of a plenum chamber, a seal-forming structure, and a positioning and stabilising structure of the patient interface; wherein the patient interface comprises a power system for powering the one or more electronic components and / or is communicable with the power system.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of Singapore Patent Application No. 10202010467U, filed on October 22, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. Background Technology

[0004] Human respiratory system and its disorders

[0005] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0006] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the airway and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar regions of the lungs are where gas exchange occurs and are called the respiratory zones. See *Respiratory Physiology*, 9th edition, by John B. West, Lippincott Williams & Wilkins, 2012.

[0007] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

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

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. This condition causes affected patients to stop breathing, typically for 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory control system characterized by rhythmic alternations of increased and decreased ventilation, known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with recurrent awakenings during sleep, which can lead to severe sleep disruption, 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 disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

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

[0013] Obesity-induced hypoventilation syndrome (OHS) is defined as a combination of severe obesity and waking chronic hypercapnia in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0014] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These symptoms include increased resistance to air movement, prolonged expiratory phase, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0015] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage leading to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0016] Chest wall disorders are a group of chest deformities that result in inefficient coupling between the respiratory muscles and the pleural cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0017] A range of treatments have been used to treat or improve these symptoms. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0018] treat

[0019] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0020] Respiratory pressure therapy

[0021] Respiratory pressure therapy involves supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy, such as that of a canister ventilator or endotracheal ventilator).

[0022] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, or if so, in any of these ways.

[0023] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0024] Non-invasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0025] Flow therapy

[0026] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one instance, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains approximately constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high-flow-rate air at the airway inlet improves ventilation efficiency by flushing or removing exhaled CO2 from the patient's anatomical dead zone. Therefore, HFT is sometimes referred to as deadspace therapy (DST). Other benefits may include increased warmth and humidity (potentially beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies throughout the respiratory cycle.

[0027] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can deliver a continuous stream of oxygen-enriched air to the patient's airway at a specified oxygen concentration (21% to 100% of the oxygen fraction in ambient air) and a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0028] Replenish oxygen

[0029] For some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0030] Respiratory therapy system

[0031] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

[0032] 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.

[0033] Patient Interface

[0034] Patient interfaces can be used to attach breathing equipment to their wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy applied, the patient interface can, for example, form a seal with an area of ​​the patient's face to deliver gas at a pressure sufficiently different from ambient pressure to achieve the therapeutic effect, such as a positive pressure of about 10 cmH2O relative to ambient pressure. For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of about 10 cmH2O into the airway. For flow therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0035] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0036] Some masks may be clinically disadvantageous for this technique, such as those that block airflow through the nose and only allow it through the mouth.

[0037] If some masks require patients to insert a portion of the mask structure into their mouths to create and maintain a seal through their lips, this may be uncomfortable or impractical for this technology.

[0038] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0039] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary considerably between individuals. Because the head comprises bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other skeletal supports of the skull. The entire head can move during the duration of a respiratory therapy session.

[0040] Due to these challenges, some face shields present one or more problems: they are obtrusive, unsightly, expensive, poorly fitted, difficult to use, and uncomfortable, especially when worn for extended periods or when patients are unfamiliar with a system. An incorrectly sized face shield can lead to reduced compliance, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those designed for administering anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield is worn during sleep.

[0041] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which could affect adherence.

[0042] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0043] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0044] Sealing Formation Structure

[0045] Patient interfaces may include seal-forming structures. Because they come into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0046] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed to, for example, cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be named by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal puffs, and oronasal masks.

[0047] For example, due to the different shapes, structures, variability, and sensitive areas of a patient's face, a sealing structure that may be effective in one area of ​​the patient's face may not be suitable for use in another area. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0048] Certain seal-forming structures can be designed for mass production, allowing a design to be suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0049] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming portion engages face-to-face with the patient's face. The seal-forming structure may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0050] Another type of seal-forming structure includes a sheet-like seal of thin material located near the periphery of the mask to provide a self-sealing effect on the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, additional force may be required to achieve a seal if the fit between the face and the mask is poor; otherwise, the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or bend during use, causing leakage.

[0051] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these elements uncomfortable.

[0052] Another form of seal formation can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0053] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0054] One form of nose pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nose pillow or nose puff is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0055] ResMed Ltd. has manufactured the following products that combine a nose pillow: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (particularly describing ResMed Ltd.'s SWIFT...) TM (Various aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (particularly describing ResMed Inc.'s SWIFT) TM (various aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (particularly describing ResMed Ltd. MIRAGE LIBERTY) TM (All aspects of the full-face mask); International Patent Application WO 2009 / 052,560 (particularly describing ResMed Ltd.'s SWIFT) TM (Various aspects of the FX nose pillow).

[0056] Stable positioning

[0057] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of the air pressure that threatens to break the seal. Therefore, various techniques have been used to position the sealing structure and maintain a sealing relationship with the appropriate part of the face.

[0058] One technique involves using adhesives. See, for example, U.S. Patent Application Publication US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0059] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and inconvenience of use.

[0060] Respiratory Pressure Therapy (RPT) device

[0061] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, RPT devices can also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0062] Pneumatic generators are known in a range of applications, such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may suffer from drawbacks related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0063] One example of a specific requirement for certain RPT devices is acoustic noise.

[0064] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0065] RPT device name A-weighted sound pressure level dB(A) Year (approximately) <![CDATA[C Series Tango TM > 31.9 2007 <![CDATA[C-series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[With H4i TM Humidified S8 Escape TM II]]> 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i Humidifier TM > 28.6 2010

[0066] One known RPT device for treating sleep-disordered breathing is the ResMed S9 Sleep Therapy System. Another example of an RPT device is a CPAP machine, such as the ResMed Stellar. TM Ventilators, including adult and pediatric models, can provide invasive and non-invasive non-dependent ventilation support for a range of patients and are used to treat a variety of conditions, such as, but not limited to, NMD, OHS, and COPD.

[0067] ResMed Elisée TM 150 ventilators and ResMed VS III TM Ventilators provide support for invasive and non-invasive ventilation in adult or pediatric patients to treat a variety of conditions. These ventilators offer volume-based and pressure-based ventilation modes with single-limb or dual-limb circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The RPT device outlet is connected via an air circuit to a patient interface such as those described above.

[0068] This provides designers with an almost limitless number of options. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute variations in one or more parameters.

[0069] air circuit

[0070] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inspiratory and expiratory breathing. In other cases, a single-branch air circuit is used for both inspiratory and expiratory breathing.

[0071] Humidifier

[0072] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface to generate humidified gas minimizes nasal mucosal dryness and increases patient airway comfort. Additionally, in colder climates, warm air applied to the area within and around the patient interface on the face is generally more comfortable than cold air.

[0073] A range of artificial humidification devices and systems are known, however they may not meet the specialized requirements of medical humidifiers.

[0074] Medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air when needed, typically in places where patients may sleep or rest (e.g., in hospitals). Bedside medical humidifiers can be small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0075] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, while others are difficult or inconvenient for patients to use.

[0076] oxygen source

[0077] Experts in this field have recognized the long-term benefits of exercise for patients with respiratory failure, slowing disease progression, improving quality of life, and extending lifespan. However, most stationary forms of exercise, such as treadmills and stationary bikes, are too strenuous for these patients. Consequently, the need for mobility has long been recognized. Until recently, this mobility was facilitated by using small compressed oxygen canisters or cylinders mounted on trolleys with small wheels. The disadvantages of these canisters are that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.

[0078] Oxygen concentrators have been used for approximately 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are large and bulky, making ordinary mobile operations difficult and impractical. Recently, companies that manufacture large stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. To make these devices highly mobile, various systems used to produce oxygen-enriched gas need to be condensed. POCs seek to utilize the oxygen they produce as efficiently as possible, minimizing weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses or “pumps,” each pulsating at the time of inhalation. This treatment mode is called pulsed oxygen delivery (POD) or demand-based delivery, and is better suited to stationary oxygen concentrators compared to traditional continuous flow delivery.

[0079] Data Management

[0080] There may be clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy is "adhering," such as the patient having used their RPT device according to one or more "adherence rules." One example of an adherence rule for CPAP therapy is requiring the patient to use their RPT device for at least four hours each night for at least 21 or 30 consecutive days to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, may manually obtain data describing the patient's treatment with the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0081] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems. For example, performance data, such as data indicating the effectiveness of treatment on the patient and / or data indicating the patient interface, would be useful to enable greater control over treatment.

[0082] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0083] Vent technology

[0084] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent may allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., to the surrounding environment).

[0085] The vent may include an opening through which gas can flow during mask use. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents may interfere with the sleep of the patient or their bed partner, for example, through noise or concentrated airflow.

[0086] Resmed Limited has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0087] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0088]

[0089] (Only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0090] The sound pressure levels of various objects are listed below.

[0091]

[0092] Screening, diagnosis and monitoring systems

[0093] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary diseases, and its application typically involves a clinical specialist. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalograms (EEG), electrocardiograms (ECG), electrooculograms (EOG), and electromyograms (EMG). For sleep-disordered breathing, PSG involves two nights of observation in a clinic: one night for pure diagnosis, and the second night for titration of treatment parameters by a clinician. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0094] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically yields a true / false result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0095] Clinicians may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may not be available or may not be able to afford them. Different clinicians may have different opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Summary of the Invention

[0096] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0097] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0098] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0099] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0100] One form of this technology includes a patient interface comprising one or more electronic components for monitoring, diagnosing, and / or treating a patient, the one or more electronic components being disposed in or on one or more of an inflatable chamber, a sealing formation, and a positioning and stabilizing structure of the patient interface; wherein the patient interface includes a power system for supplying power to the one or more electronic components and / or being able to communicate with the power system.

[0101] In some forms of this technology, the patient interface includes: an inflation chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient pressure, the inflation chamber including an inflation chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for the patient to breathe; a sealing structure constructed and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening such that an airflow at the therapeutic pressure is delivered to at least one inlet of the patient's nostril, the sealing structure being constructed and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use; a positioning and stabilizing structure for providing forces to hold the sealing structure in a therapeutically effective position on the patient's head; and one or more electronic components for monitoring, diagnosing, and / or treating the patient, the one or more electronic components being disposed in or above one or more of the inflation chamber, the sealing structure, and the positioning and stabilizing structure; wherein the patient interface includes a power system for supplying power to and / or communicating with the one or more electronic components.

[0102] In one form, the power system includes an energy harvesting system that converts energy generated during the use of the patient interface into electrical energy to power one or more electronic components. The energy harvesting system can directly power one or more electronic components and / or charge energy storage devices such as batteries or capacitors. Therefore, the need for a separate power supply or recharging mechanism can be reduced or even eliminated.

[0103] For example, the energy generated during the use of the patient interface can be one or more of the following: mechanical energy generated by or during breathing; mechanical energy generated by patient movement; mechanical energy from airflow within the patient interface; and thermal energy from the patient's skin and / or from exhaled air.

[0104] In one form of this technology, the energy harvesting system includes at least one energy harvesting device positioned in the airflow path of the patient interface. For example, this can be positioned at the air inlet of the patient interface, such as within the inflation chamber inlet port, or adjacent to the inflation chamber inlet port and within the inflation chamber.

[0105] The at least one energy harvesting device may include a turbine generator. The turbine generator may include a rotor comprising a plurality of turbine blades and a plurality of magnets arranged around the periphery of the rotor. In some forms, the turbine generator includes a sealed stator assembly housing a plurality of coils, the stator assembly being arranged around the rotor.

[0106] The at least one energy harvesting device may include a turbine generator. The turbine generator may include a rotor comprising a plurality of turbine blades and a plurality of magnets positioned toward the base of the turbine blades. In some forms, stator coils may be embedded within a fixed shaft about which the rotor rotates.

[0107] In some configurations, positioning the magnet near the base of the turbine blade can produce low rotor inertia (e.g., compared to positioning the mass of the magnet towards the periphery of the turbine blade). This allows the turbine blade to rotate even under relatively low airflow conditions.

[0108] The energy harvesting system may alternatively or additionally include at least one piezoelectric film. For example, at least one of the piezoelectric films may be attached to, or disposed within, the inflation chamber and / or sealing and / or positioning and stabilizing structure.

[0109] The energy harvesting system may alternatively or additionally include at least one thermoelectric generator (TEG) module.

[0110] For example, at least one TEG module can be disposed within the positioning and stabilizing structure. This at least one TEG module can be positioned to contact the patient's skin.

[0111] In another example, at least one TEG module is arranged such that a first surface of the TEG module is exposed to the interior of the inflation chamber, and a second surface opposite the first surface is exposed to the surrounding environment.

[0112] In some forms of this technology, the power system includes an external charging circuit configured to charge an energy storage device.

[0113] For example, the external charging circuit may be a component of a respiratory pressure therapy device configured to deliver an airflow to an inflation chamber. In some forms, the external charging circuit may be connected to an energy storage device via one or more cables incorporated into or above an air circuit connecting the respiratory pressure therapy device and the inflation chamber.

[0114] In some forms of this technology, one or more electronic components include one or more sensors and / or one or more actuators.

[0115] In some forms, at least one sensor and / or at least one actuator may be partially exposed to the surrounding environment at the outer surface of the positioning and stabilizing structure; and / or partially exposed at the patient contact surface of the positioning and stabilizing structure so as to contact the patient's skin during use.

[0116] In some forms, at least one sensor and / or at least one actuator is at least partially embedded between the outer layer of the positioning and stabilizing structure and the patient contact layer.

[0117] In some forms of this technology, at least one sensor and / or at least one actuator includes a circuit formed at least in part by one or more conductive lines and / or one or more conductive ink lines.

[0118] In some forms of this technology, one or more electronic components include a wireless communication interface for transmitting data from one or more sensors to one or more external computing devices, and / or for receiving data from one or more external computing devices at one or more actuators.

[0119] For example, one or more sensors and / or one or more actuators may include one or more of the following: accelerometer; gyroscope; humidity sensor; temperature sensor; microphone; camera; pulse oximeter; EEG sensor; EMG sensor; EOG sensor; touch sensor; vibration device; and audio output device.

[0120] Another aspect of this technology is a patient interface, which is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0121] One aspect of this technology is a method for manufacturing equipment.

[0122] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for people without medical training, those who are clumsy, visually impaired, or have limited experience in using this type of medical device.

[0123] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., a person in their household).

[0124] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment.

[0125] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0126] Another aspect of this technology includes a patient interface comprising: an inflatable chamber pressurizable to a treatment pressure at least 4 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an airflow at the treatment pressure for patient breathing; and a sealing structure constructed and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening such that an airflow at the treatment pressure is delivered to at least one inlet of the patient's nostril, the sealing structure being constructed and arranged to allow airflow at the treatment pressure to be delivered to at least one inlet of the patient's nostril. The interface is used to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle; a positioning and stabilizing structure for providing forces that hold the sealing structure in a therapeutically effective position on the patient's head; and an electrical system for converting energy generated during use of the patient interface into converted electrical energy for powering at least a portion of the patient interface, wherein the energy generated during use of the patient interface is one or more of the following: mechanical energy generated by or during breathing; mechanical energy generated by patient movement; mechanical energy from airflow within the patient interface; and thermal energy from the patient's skin and / or exhaled air.

[0127] In some forms, the power system provides DC voltage to at least a portion of the patient interface.

[0128] In some forms: a) at least a portion of the patient interface is an energy storage device electrically connected to and configured to supply electrical energy to the power system; b) the power system is configured to supply converted electrical energy to the energy storage device for recharging; c) an external charging circuit is electrically connected to the energy storage device and configured to supply electrical energy to the energy storage device; d) the at least a portion of the patient interface further includes one or more electronic components for monitoring, diagnosing, and / or treating the patient; e) one or more electronic components receive electrical energy directly from the power system; and / or f) one or more electronic components receive electrical energy directly from the energy storage device.

[0129] In some forms, at least a portion of the patient interface also includes one or more electronic components for monitoring, diagnosing, and / or treating the patient, wherein the one or more electronic components are disposed in or on one or more of the inflation chamber, the sealing formation structure, and the positioning and stabilization structure.

[0130] In some forms: a) at least one energy harvesting device includes a turbine generator; b) the turbine generator includes a rotor comprising a plurality of turbine blades and a plurality of magnets disposed around the periphery of the rotor; c) the turbine generator includes a sealed stator assembly housing a plurality of coils disposed around the rotor; d) the sealed stator assembly further includes a plurality of spools around which the plurality of coils are wound; e) the number of spools is equal to the number of magnets; f) the turbine generator is located in the inlet of the patient interface, upstream of the patient in use; and / or g) the turbine generator is located in the outlet of the patient interface, downstream of the patient in use.

[0131] In some forms: a) at least one energy harvesting system includes at least one piezoelectric film; b) at least one of the piezoelectric films is attached to, or disposed within, the air chamber and / or the sealing structure and / or the positioning and stabilizing structure; c) the piezoelectric film is a sensor and is configured to measure patient snoring by sensing vibration and / or noise; d) the piezoelectric film is positioned in the air inlet of the patient interface, upstream of the patient in use; e) the piezoelectric film is positioned in the exhaust port of the patient interface, downstream of the patient in use; f) at least one piezoelectric film is sandwiched between layers of the positioning and stabilizing structure; and / or g) at least one piezoelectric film is configured to bend due to movement in the positioning and stabilizing structure.

[0132] In some forms: a) at least one energy harvesting system includes at least one thermoelectric generator (TEG) module; b) at least one TEG module is at least partially exposed and arranged to contact the patient's skin; c) at least one TEG module is disposed within a positioning and stabilizing structure; d) at least one TEG module is arranged such that a first surface of the TEG module is exposed to the interior of the inflation chamber, and a second surface opposite the first surface is exposed to the surrounding environment.

[0133] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0134] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0135] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0136] Respiratory therapy system

[0137] Figure 1A A system including a patient 1000 is shown, who wears a patient interface 3000 in the form of a nose pillow, which receives a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine position.

[0138] Figure 1B A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask is shown, which receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0139] Figure 1C A system including a patient 1000 is shown, who wears a patient interface 3000 in the form of a full-face mask, which receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0140] Respiratory system and facial anatomy

[0141] Figure 2AA schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0142] Figure 2B This diagram shows a view of the human upper airway, including the nasal chambers, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0143] Figure 2C It is a front view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0144] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and anteroposterior directions are also marked.

[0145] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0146] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0147] Figure 2G A side view showing the surface features of the nose.

[0148] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0149] Figure 2I The diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0150] Figure 2J A frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal conchae, as well as the maxilla and mandible, are also labeled.

[0151] Figure 2KA side view of the skull, showing the surface contours of the head and several muscles, is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0152] Figure 2L The frontal lateral view of the nose is shown.

[0153] Patient Interface

[0154] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0155] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0156] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0157] Figure 3D A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at the point is indicated. The curvature at the point has a zero value.

[0158] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0159] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0160] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is shown. The edges of the surface are shown. The vaulted and saddle-shaped areas are shown.

[0161] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is shown. The edges of the surface are shown. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0162] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0163] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

[0164] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The structure defines the surface of the two-dimensional hole.

[0165] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0166] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the air bladder is also shown. The inner surface defines two-dimensional openings in the mask.

[0167] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0168] Figure 3O The left-hand rule is shown.

[0169] Figure 3P The right-hand rule is shown.

[0170] Figure 3Q The left ear is shown, including the left ear spiral.

[0171] Figure 3R The right ear is shown, including the right ear spiral.

[0172] Figure 3S A right-handed spiral is shown.

[0173] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0174] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0175] Figure 3V It shows Figure 3UThis is a view of the rear of the inflation chamber. The orientation of this view is perpendicular to the central contact plane. Figure 3V The sagittal plane divides the air chamber into the left and right sides.

[0176] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, said cross-section is in Figure 3V The image shows a section taken at the sagittal plane. The "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the pneumatic chamber liner at two points on the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the liner in this region, the intermediate contact plane can be a tangent at the upper and lower points.

[0177] Figure 3X It shows Figure 3U The position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 generally coincides with the midsagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact plane generally corresponds to the "facial plane". Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0178] Figure 3Y A patient interface in the form of a nasal cannula according to the present technology is shown.

[0179] Figure 4 A top perspective view depicting a patient interface according to an example of this technology is shown.

[0180] Figure 5 A front perspective view of the patient interface according to an example of this technology is depicted.

[0181] Figure 6A A front perspective view depicting a patient interface according to an example of this technology worn by a patient.

[0182] Figure 6B A front view of a patient interface according to an example of this technology, worn by a patient, is depicted.

[0183] Figure 7A The positioning and stabilization structure of a patient interface according to the present technology is shown in a first use position on the patient's head.

[0184] Figure 7B It shows Figure 7AIts positioning and stabilizing structure, which serves as part of the patient interface, is located in the second usage position on the patient's head.

[0185] Figure 8 Is it through Figure 7A A schematic cross-sectional view of a part of the positioning and stabilizing structure.

[0186] Figure 9A It is a block diagram of a patient interface that includes multiple electronic modules powered by a rechargeable battery that is charged by an external charging circuit.

[0187] Figure 9B It is used to Figure 9A A schematic diagram of the first arrangement of power supply to the electronic components of the patient interface.

[0188] Figure 9C It is used to... Figure 9A A schematic diagram of the second arrangement for powering the electronic components of the patient interface.

[0189] Figure 9D It is used to... Figure 9A A schematic diagram of the third arrangement for powering the electronic components of the patient interface.

[0190] Figure 10 It is a block diagram of a patient interface that includes multiple electronic modules powered by an energy harvesting system.

[0191] Figure 11A This is an exploded view of an example of an energy harvesting device used for a patient interface.

[0192] Figure 11B It shows Figure 11A Another view of the various components of the energy harvesting device.

[0193] Figure 11C This is a plan view of a partially assembled energy harvesting device.

[0194] Figure 11D This is a plan view of a fully assembled energy harvesting device.

[0195] Figure 11E This is a front view of an alternative instance of the rotor.

[0196] Figure 12A The first series of voltage signals from a patient interface with a piezoelectric thin-film-based energy harvesting device incorporated therein are shown.

[0197] Figure 12B A second series of voltage signals from a patient interface with a piezoelectric thin-film-based energy harvesting device incorporated therein is shown.

[0198] RPT device

[0199] Figure 13A An RPT device of one form according to the present technology is shown.

[0200] Figure 13B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0201] Figure 13C A schematic diagram of the electrical components of one form of RPT device according to the present technology is shown.

[0202] Figure 13D A schematic diagram of an algorithm implemented in one form of RPT device according to the present technology is shown.

[0203] Figure 13E This illustrates one form of the present technology. Figure 13D The flowchart shows the method executed by the treatment engine module.

[0204] Humidifier

[0205] Figure 14A An isometric view of one form of humidifier according to the present technology is shown.

[0206] Figure 14B An isometric view of one form of humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0207] Figure 14C A schematic diagram of one form of humidifier according to the present technology is shown. Detailed Implementation

[0208] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this invention is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0209] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example can be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features can form another example.

[0210] treat

[0211] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0212] In some instances of this technology, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0213] In some instances of this technology, mouth breathing is limited, restricted, or prevented.

[0214] Respiratory therapy system

[0215] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 6000.

[0216] Patient Interface

[0217] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy. An example of such a patient interface 3000 is... Figure 3A As shown in the image.

[0218] Figure 4 and Figure 5 A patient interface 3000 according to another embodiment of the present technology is depicted. The patient interface 3000 includes a sealing formation structure 3100 connected to an inflation chamber 3200. The inflation chamber 3200 may be provided with one or more vents 3400.

[0219] Figure 4 and Figure 5The patient interface 3000 may include a positioning and stabilization structure 3300, which includes a catheter 3301. The catheter 3301 serves two purposes: 1) to position and stabilize the patient interface 3000 in a therapeutically effective position on the patient's head during use, and 2) to supply pressurized breathable gas to an inflation chamber 3200. Thus, the catheter 3301 may be constructed of a flexible, biocompatible material and may also be formed into a hollow structure. The catheter 3301 can be connected to the inflation chamber 3200 using a clip 3303 to provide a pneumatic connection therebetween. The catheter 3301 may also include a strap connector 3302 for connection to a strap (not shown) that passes through the back of the patient's head during use. The catheter 3301 may also include a flexible portion 3304 that provides flexibility to accommodate patient heads of different sizes and shapes. The patient interface 3000 includes a bent connector 3305 for connecting to a decoupling structure 3500. The bend connector 3305 may be hollow to allow gas from the conduit 3301 to pass through the decoupling structure 3500, through the bend connector 3305 and into the conduit 3301.

[0220] In one embodiment, the patient interface 3000 includes at least one decoupling structure 3500, such as a swivel or ball joint. The decoupling structure 3500 may be in the form of a bend. The decoupling structure 3500 may include a swivel connected to an air circuit 4170 and a patient interface connector (not shown) connected to the patient interface 3000. The patient interface connector may allow the decoupling structure 3500 to rotate relative to the patient interface 3000. The decoupling structure 3500 may also include vents 3401. These vents 3401 may allow pressurized gas delivered to the patient interface 3000 to be expelled. CO2 exhaled by the patient may also escape into the atmosphere through the vents 3401 in the decoupling structure 3500. In another embodiment, the vents may be provided in an additional component, such as an adapter in the form of a relatively short flexible or rigid conduit (2 to 10 cm), having holes for attachment to the patient interface 3000, for example, to the decoupling structure 3500. Short catheters can be sold with the patient interface and include an appropriate number of orifices to allow the discharge of pressurized gas, thereby regulating the treatment pressure to an appropriate level for a given patient interface 3000. The CO2 vent and exhaust ports can have the same or different capacities; for example, the exhaust port may provide a higher or lower flow rate than the CO2 vent.

[0221] Figure 6A and Figure 6B This patient interface 3000 is shown on a patient. A strap 3306 can be connected to a strap connector 3302 to secure the patient interface 3000 in a desired sealed position for treatment.

[0222] International Publication No. WO2017 / 185140 provides a further description of an exemplary patient interface 3000 whose properties can be applied to this technology, and that international publication is incorporated herein by reference in its entirety.

[0223] An unsealed patient interface 3800 in the form of a nasal cannula includes nasal tips 3810a, 3810b through which air can be delivered to the corresponding nostrils of a patient 1000 via corresponding orifices in its tip. This nasal cannula typically does not form a seal with the inner or outer skin surface of the nostril. Air to the nasal tip can be delivered through one or more air supply cavities 3820a, 3820b connected to the unsealed patient interface 3800. Cavities 3820a, 3820b lead from the unsealed patient interface 3800 to a respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivery flow therapy, where the RPT device generates an airflow at a controlled flow rate rather than a controlled pressure. The "vent" at the unsealed patient interface 3800 is a passage between the tips 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800, which leads to the atmosphere through the patient's nostrils. Excess airflow escapes into the surrounding environment through this "vent".

[0224] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0225] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure higher than ambient pressure.

[0226] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 2 cmH2O relative to the surrounding environment.

[0227] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 4 cmH2O relative to the surrounding environment.

[0228] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cmH2O relative to the surrounding environment.

[0229] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 8 cmH2O relative to the surrounding environment.

[0230] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 10 cmH2O relative to the environment.

[0231] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 20 cmH2O relative to the environment.

[0232] Sealing Formation Structure

[0233] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may also provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The area where a seal actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the position of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0234] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0235] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0236] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and resilient material such as silicone.

[0237] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one form of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, and another form suitable for small-sized heads but not for large-sized heads.

[0238] Sealing mechanism

[0239] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the pneumatic chamber 3200, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0240] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the pneumatic chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the pneumatic chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0241] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and positioned in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0242] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0243] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0244] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0245] bridge or ridge of the nose

[0246] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0247] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face during use.

[0248] upper lip area

[0249] In one form, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the upper lip region (i.e., above the lips) of the patient's face during use.

[0250] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0251] Chin area

[0252] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the chin area of ​​the patient's face during use.

[0253] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the chin area of ​​a patient's face during use.

[0254] Forehead area

[0255] In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0256] nose pillow

[0257] In one form, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal flaps or nasal pillows, each flap or pillow being constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0258] A nasal pillow according to one aspect of the present technology includes: a truncated cone, at least a portion of which forms a seal on the underside of the patient's nose; a rod; and a flexible region located on the underside of the truncated cone and connecting the truncated cone to the rod. Furthermore, the nasal pillow connection structure of the present technology includes a flexible region adjacent to the base of the rod. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of displacement and angle between the truncated cone and the structure to which the nasal pillow is connected. For example, the position of the truncated cone can be axially moved toward the structure to which the rod is connected.

[0259] pneumatic chamber

[0260] The air chamber 3200 has a periphery shaped to complement the surface contour of a normal person's face in the area where a seal will be formed during use. In use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surface of the face. Actual contact with the face is provided by a sealing structure 3100. The sealing structure 3100 may extend along the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0261] In some forms of this technology, the pneumatic chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the pneumatic chamber. Such a form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment compliance.

[0262] In some forms of this technology, the air chamber 3200 is made of a transparent material (e.g., transparent polycarbonate). Using a transparent material reduces the prominence of the patient interface and helps improve treatment compliance. Using a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0263] In some forms of this technology, the pneumatic chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve patient compliance.

[0264] Positioning and stabilizing structure

[0265] The sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by positioning and stabilizing structure 3300.

[0266] In one configuration, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the positive pressure effect in the inflation chamber 3200 to lift the face away.

[0267] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0268] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0269] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with how a patient wears it while sleeping. In one example, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0270] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0271] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large and bulky to prevent the patient from lying in a side-lying position, wherein the lateral area of ​​the patient's head rests on a pillow.

[0272] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. This decoupling portion does not resist compression and may be, for example, a flexible or soft band. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0273] In one form of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0274] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be taut during use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In an example, the strap may be configured as a tie.

[0275] In one form of the technology, the positioning and stabilizing structure includes a first frenulum, which is configured and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraaural base of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0276] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0277] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0278] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on it while sleeping.

[0279] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow moisture to be transferred through the straps.

[0280] In one form of this technology, such as Figure 7A and Figure 7B As shown, the positioning and stabilization structure 6300 of the patient interface 6000 may have an integrated connection port 6600 to facilitate non-therapeutic configuration of the positioning and stabilization structure as a headband (e.g., Figure 7A (As shown) Switch to treatment configuration (such as) Figure 7B As shown), the positioning and stabilizing structure 6300 can be connected to the air circuit 4170, which is in communication with the inflation chamber 6200, via the connection port 6600.

[0281] Many different forms of connection are possible between the air circuit 4170 and the connection port 6600, as long as a substantially airtight seal is formed to prevent or significantly reduce pressure leakage during treatment. For example, port 6600 may include a magnetic element 6610 located on its inner surface for connection to a corresponding magnetic element on a connector located at one end of the air circuit 4170. In another instance, the connector of the air circuit may be attached to the connection port 6600 by a snap-fit ​​engagement (e.g., a ring snap-fit ​​engagement or a cantilever snap-fit ​​engagement, either of which may be rigid-to-rigid or rigid-to-elastic) or a friction engagement.

[0282] like Figure 7A As shown, the positioning and stabilizing structure 6300 includes an upper textile portion 6310 that includes an elastic circumferential band for fitting to a patient's head in use. A first lower textile portion 6320 is hinged to (e.g., integral with) and extends from the upper textile portion 6310. The positioning and stabilizing structure 6300 is used to apply forces to the sealing forming structure 6100, such as... Figure 7B As shown. The sealing structure 6100 can be a nasal mask with an inflation chamber 6200. Other types of masks, such as full-face masks and oronasal masks, can also be used as part of the patient interface along with the positioning and stabilization structure 6300.

[0283] In this example, the positioning and stabilizing structure 6300 is formed as a band having a front section 6302 and a rear section 6304, wherein the front section 6302 has a first bifurcation section (crossing points 6312, 6314), such that the first bifurcation forms a first portion of the upper textile portion 6310 and a second bifurcation forms a first lower textile portion 6320. Therefore, the upper textile portion 6310 forms a first band or strap that can be wrapped around the patient's forehead during use, such as... Figure 7A As shown, the first lower textile portion 6320 forms a downwardly stretchable second band or strap to engage directly or indirectly with the sealing structure 6100, thereby providing a force to hold the sealing structure 6100 in a therapeutically effective position on the patient's head.

[0284] In some forms of this technology, the rear section 6304 may further include a bifurcation section comprising a first rear portion 6306 as a second part of the upper textile portion 6310 and a second rear portion or lower portion 6308 as a second lower textile portion, such as... Figure 7B As shown. The bifurcation of the posterior segment 6304 enables greater support because it provides tension at intervals in the patient's head or behind or near the occipital bone, and also provides greater adjustability, allowing the patient to better position and stabilize the structure 6300 for greater comfort.

[0285] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide a holding force corresponding to a range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, and another form suitable for small-sized heads but not for large-sized heads.

[0286] Sensor and actuator devices for patient interfaces

[0287] In some forms of this technology, the patient interface may have one or more sensors and / or actuators disposed therein for measuring the patient's physiological and sleep data. The one or more sensors and actuators may be embedded within the patient interface 3000 or 6000, for example, between the textile layers of the headband of the patient interface, or may be attached to the inner and / or outer surfaces of the headband 3300, 6300, or other components of the patient interface. For example, one or more sensors and / or actuators may be integrated into the positioning and stabilization structures 3300, 6300 and / or another component such as the sealing formation structures 3100, 6100, or the inflation chambers 3200, 6200.

[0288] Advantageously, sensors embedded in the patient interface can help collect sleep-related data and physiological indicators, such as vital signs; this can be used to determine improvements in sleep and health by comparing data before and after treatment. This data can be processed to inform the patient how the treatment has improved their sleep. For example, before starting treatment, the patient can wear a positioning and stabilization structure 6300 with integrated sensors as a headband, such as... Figure 7A As shown, physiological and sleep data can be recorded during the patient's sleep (or during the day in the case of physiological data). After the start of treatment, the positioning and stabilization structure 6300 is in Figure 7BIn the treatment configuration shown, further physiological and sleep data can be recorded and compared with data recorded before treatment began. The physiological and sleep data can be transmitted to external computing devices, such as the patient's smartphone, and / or to a monitoring server operated or accessible by a clinician or other healthcare provider.

[0289] Because patients are able to wear the positioning and stabilizing structure 6300 as a headband and receive data-based feedback on how the treatment actually works (e.g., via an app executed on the patient's smartphone), adaptation is smoother and patient compliance is more likely. The collected data can also be used to determine group-level sleep and / or physiological characteristics of one or more groups of patients receiving respiratory therapy, potentially enabling better treatment customization for patients belonging to specific categories, or otherwise enabling optimization of the operation of the RPT device 4000.

[0290] In some forms of this technology, using sensors integrated into and / or attached to the mask to measure functional parameters on the patient side can provide improved, active feedback-based control of the RPT device 4000 connected to the patient interface, for example, improved feedback control of the pressure generator 4140 of the RPT device 4000. Figure 13B ).

[0291] For example, refer to Figure 7B and Figure 8 The upper textile section 6310 of the positioning and stabilization structure 6300 may have multiple electronic modules (actuators and / or sensors) 6354, 6356, 6358, and 6360 integrated therein. A processor module 6350 may also be integrated into the positioning and stabilization structure 6300, typically also into the upper textile section 6310; however, it is understood that the processor module 6350 may be located in other locations within the positioning and stabilization structure 6300. The processor module may be disposed within the holding structure 6380. The processor module 6350 may have an integrated transceiver for sending data to and receiving data from an external computing device. An energy storage device, such as a battery module 6352, may also be included to power the various electronic components of the positioning and stabilization structure 6300 (sensors / actuators 6354 to 6360 and processor module 6350). In some forms of this technology, other energy storage devices, such as supercapacitors, may be used.

[0292] like Figure 8As shown, sensors and associated electronics can be at least partially integrated between the fabric layers of the upper textile portion 6310. For example, various sensor / actuator modules and / or associated circuitry, processor module 6350, and battery module 6352 can be located between the inner patient contact fabric layer 6370 and the outer non-patient contact fabric layer 6372.

[0293] The sensor and / or actuator module integrated in the positioning and stabilization structure 6300 can be electrically communicated with the processor module 6350 and the battery module 6352, for example, via bus 6365. Bus 6365 can be disposed between two insulating layers 6366, which provide electrical insulation and also prevent moisture ingress, such as from sweat absorbed by the inner fabric layer 6370. Insulating layer 6366 can be, for example, a non-conductive polymer or elastomer film; however, it should be understood that other electrically insulating materials may also be used.

[0294] In some forms of this technology, a thermally insulating layer may be provided between at least some electronic components of the positioning and stabilizing structure 6300, noting that these components will tend to generate heat during use. Therefore, the thermally insulating layer helps improve patient comfort. For example, layer 6366, which is closest to the patient contacting inner layer 6370, may be both thermally and electrically insulating, or an additional thermally insulating layer may be inserted between the electrically insulating layer 6366 and the inner layer 6370. In some instances, the inner layer 6370 itself may be thermally insulating.

[0295] In some forms of this technology, sensor and / or actuator modules 6354 to 6360 and their associated circuitry, as well as other modules including processor module 6350 and battery module 6352, can be housed within retaining structures 6380 to 6390 fixed to insulating layer 6366 and / or inner fabric layer 6370. Each retaining structure 6380 to 6390 is electrically connected, for example, to bus 6365 and may include electrical contacts to electrically connect the circuitry of the sensor module (or the circuitry associated with the sensor module) to bus 6365, and thus also to battery module 6352 and processor module 6350. In some instances, communication between modules 6350-6360 and bus 6365 can be via conductive ink lines and / or conductive wires woven into or otherwise integrally formed with fabric layers 6370 and / or 6372. In some embodiments, electrical contacts and / or circuit traces may be contained only in the outer layer 6372 so as to be unaffected by sweat from the patient during use.

[0296] In some instances, modules 6350-6360 may be detachable from sensor holding structures 6380-6390, allowing a particular module to be used for other modules with different functions, or to replace modules that have ceased operation or are at the end of their lifespan. For example, modules 6350-6360 (and / or their electrically coupled circuit modules 6355, 6357, 6359, 6361, 6363, if applicable) may be releasably attached to sensor holding structures 6380-6392. For this purpose, the outer surface of the module may form a frictional engagement with the inner surface of the wall of sensor holding structures 6380-6390, or a snap-fit ​​engagement, such as a ring snap-fit ​​or a cantilever snap-fit, with the wall or other internal or external portion of the sensor holding structure. In some embodiments, non-mechanical connections, such as magnetic connections, may be used to hold modules 6350-6360 in the respective holding structures 6380-6390.

[0297] In some forms of this technology, retaining structures 6380 to 6390 may include a pocket formed in the upper textile portion 6310 (e.g., by forming a slit in the outer layer 6372 or the inner layer 6370), into which modules 6350 to 6360 (or their associated circuitry) may be inserted for electrical coupling with bus 6365.

[0298] Battery module 6352 may include a rechargeable battery. The battery can be recharged by connecting it to an external power source (e.g., via a micro-USB or USB-C port of battery module 6352, e.g., via a port exposed by the outer fabric layer 6372)) or by inductive charging. In some embodiments, battery module 6352 may be a disposable battery, for example, disposed within a pocket 6382 of the upper textile portion 6310, and can be removed by the patient for replacement with a new battery.

[0299] In some forms of this technology, one or more sensor modules and / or actuator modules can be completely encapsulated between fabric layers 6370, 6372, such that no part of the one or more sensor modules is exposed. For example, actuator module 6360 can be coupled to associated circuitry 6361 housed in sensor holding structure 6390. Both actuator module 6360 and circuitry module 6361 are entirely located between fabric layers 6370, 6372. In another example, sensor module 6356 and associated circuitry 6357 can be entirely located between fabric layers 6370, 6372. An example of a fully embedded sensor module 6356 is an accelerometer or gyroscope.

[0300] In some forms of this technology, the sensor module or actuator module may be at least partially exposed. For example, a humidity sensor 6358 coupled to circuit module 6359 may be at least partially exposed to the surrounding environment through an outer fabric layer 6372 to measure the humidity of the patient's environment. For this purpose, the outer fabric layer 6372 may include holes through which the surface of the humidity sensor 6358 may be exposed. In another example, a sensor 6354 coupled to circuit 6355 may have its surface exposed through an inner fabric layer 6370 (e.g., through holes formed therein), such that the sensor surface can contact the patient's skin when the patient wears the positioning and stabilization structure 6300. For example, sensor 6354 may be a pulse oximeter.

[0301] Although the electronic components are described above as having a modular construction and being able to be switched out for other components in at least some cases, in some forms of this technology, one or more electronic components (such as sensors or actuators) may be woven or otherwise integrated into the material of the upper textile portion 6310, for example, into the outer fabric layer 6372 or the inner fabric layer 6370, and / or integrated into another portion of the positioning and stabilizing structure 6300, such as the lower textile portion 6320, and / or one or both of the back portions 6306, 6308. This allows sensors to be distributed over a larger area for more information and / or more accurate measurements.

[0302] In some forms of this technology, the sensor may include a touch sensor 6362, such as a capacitive or resistive sensor or a tactile switch, and may have associated circuitry enabling the sensor to function as a "pause" button. For example, the touch sensor 6362 may be integrated into an exposed area of ​​the positioning and stabilization structure 6300 or the sealing formation structure 6100. In one example, the touch sensor 6362 may be used as… Figure 8 The touch sensor 6362 is positioned on the upper textile section 6310 as shown. The touch sensor 6362 can communicate with the processor / transceiver 6350 as previously described, so that the signals recorded by the touch sensor 6362 and the circuit module 6363 (when the touch sensor 6362 is in "on" mode) can be transmitted by the processor / transceiver 6350 to an external device, such as the pressure generator 4140 of the RPT device 4000.

[0303] For example, if a patient places the patient interface 6000 in the appropriate position and wishes to speak, or wakes up in the middle of the night and feels uncomfortable due to the positive pressure in the inflation chamber 6200, he or she can activate the touch sensor 6362 to a "pause" mode by making slight, continuous touches. The circuit module 6359 can detect such a touch and transmit a pause signal to the pressure generator 4140 (e.g., via the data communication interface 4280). Figure 13CThis causes the flow rate to immediately decrease to a very low value (e.g., just enough to avoid the feeling of suffocation). When the "pause" mode is released, this is detected by the circuit module 6363, and another signal is sent to the pressure generator 4140 to reset the ramp algorithm implemented by the RPT device 4000.

[0304] Some forms of this technology may include one or more sensors for determining a patient's sleep posture and movement before and / or during respiratory therapy. In some forms, the determined sleep posture and movement may be used to regulate the operation of pressure generator 4140 and / or to provide sensory stimulation to the patient to change posture. For example, if one or more sensors detect an amount of apnea and / or hypopnea events exceeding a certain threshold, and / or a decrease in blood oxygenation (regardless of whether pressure generator 4140 is operational at the time), this may indicate supine positioning. One or more actuators may receive activation signals based on detection, and the activation signals may cause one or more actuators to generate vibrations or other tactile stimuli to adequately stimulate the patient, thereby causing the patient to switch to another sleep posture.

[0305] For example, the positioning and stabilization structure 6300 or the sealing structure 6100 may incorporate an accelerometer and / or gyroscope (not shown). The accelerometer and / or gyroscope may be completely encapsulated between the fabric layers 6370 and 6372 of the upper textile portion 6310, for example, as shown in the image. Figure 8 As shown at 6360. Both the accelerometer and the gyroscope communicate with the processor / transceiver 6350, so that the data recorded by them can be transmitted to the RPT device 4000 to regulate the operation of the pressure generator 4140.

[0306] Measurements recorded by the accelerometer can be used to determine the patient's sleep posture and adjust treatment accordingly. When a supine position is detected, the pressure generator 4140 can slowly increase the treatment pressure to prevent sleep apnea events. When a side-sleeping position is detected, the treatment pressure can be decreased. When an upright position (e.g., reading before bed, wearing a mask) is detected, the flow and pressure are just sufficient to avoid a feeling of suffocation.

[0307] Measurements recorded by the gyroscope can be used to determine the patient's movement and adjust treatment accordingly. When significant movement indicating the patient may be awake is detected, the treatment pressure can be kept low enough to avoid a feeling of suffocation. As the movement diminishes, the treatment pressure can be increased very slowly to avoid discomfort.

[0308] In some forms of this technology, accelerometer and / or gyroscope measurements can be used to determine the patient's sleep stage and accordingly turn the pressure generator 4140 on or off. For example, if treatment begins while the patient is still awake, the patient may have difficulty falling asleep. Therefore, if the accelerometer and / or gyroscope measurements indicate a state of wakefulness or light sleep, the pressure generator 4140 can remain in an "off" or "paused" state, and once the measurements indicate the patient is in a deep sleep stage, the pressure generator 4140 is turned on (typically, with a gradual increase). Conversely, for example, if treatment has begun and it is detected that the patient has switched from deep sleep to light sleep, where treatment could wake the patient, the pressure generator 4140 can be paused until the patient is back in deep sleep.

[0309] In some forms of this technology, a pulse oximeter integrated into the positioning and stabilization structure 6300 can be used to assess sleep health. For example, the pulse oximeter 6354 and associated circuitry 6355 can be integrated into the upper textile portion 6310 of the positioning and stabilization structure 6300, as... Figure 8 As shown. The pulse oximeter 6354 is exposed through perforations in the inner fabric layer 6370, allowing it to contact the skin of the patient's forehead. Measurements recorded by the pulse oximeter 6354 can be used to determine blood oxygen saturation levels and heart rate during the wearing of the patient interface 6000, and this data can be transmitted to the RPT device 4000, or an external computing device, such as a smartphone, other mobile computing device, or the patient's on-lap or desktop computing system. Time-series data can be combined to provide patients with feedback on their health levels, as well as recommendations for follow-up (e.g., provided by a clinician).

[0310] In one instance, the apnea-hypopnea index (AHI) can be determined based on sensor measurements. The AHI is a measure used by clinicians to classify the severity of sleep apnea. AHI calculation can use a combination of data from different sensors, such as blood oxygen levels and heart rate (e.g., measured by a PPG sensor), and chest movements (e.g., measured by an accelerometer and / or gyroscope). The AHI value can be used to determine when “apnea” occurs.

[0311] Therefore, by tracking AHI over time, clinicians can determine whether a patient has sleep apnea and provide details of its severity. Furthermore, by analyzing AHI data and other sensor data, clinicians can not only correlate the frequency of apnea with specific sleep postures (e.g., supine or lateral sleeping), but also adjust CPAP therapy according to the patient's specific needs. For example, temperature and / or humidity sensors located inside the inflation chamber at the patient interface, along with a pre-defined nasal or full-face mask, can be used to detect the amount of mouth breathing. Additionally, pressure generator 4140 settings that produce the most suitable flow rate for the patient can be recommended based on sensor measurements. For example, clinicians can prescribe a higher pressure setting (or equivalent, a higher flow rate) for patients with a high detection rate of apnea or hypopnea events. The prescribed flow rate can also be determined based on the patient's anatomy, such as if the patient has a more prone-to-collapse upper airway.

[0312] In some forms of this technology, the EEG sensor can be disposed in the positioning and stabilization structure 6300, for example, in the upper textile section 6310. The EEG sensor can be in a similar manner to... Figure 8 The pulse oximeter 6354 is partially exposed, allowing it to contact the skin on the patient's forehead. Typically, the EEG sensor includes multiple EEG electrodes that generate signals that can be analyzed to detect sleep stages. These signals can be transmitted (via processor / transceiver 6350) to an external device, such as the patient's smartphone, and information on sleep stages, cycles, and durations can be used to provide the patient with feedback on the progress of sleep therapy, as well as recommendations for improving health. For example, EEG sensor measurements can be used for accurate sleep staging, enabling more precise determination of when apnea or sleep awakening occurs, such as during sleep studies.

[0313] In some forms of this technology, sleep stage information can be transmitted to the RPT device 4000, so that the pressure generator 4140 can use the sleep stage information to adjust the therapeutic pressure to avoid awakening or blocking events.

[0314] In some forms of this technology, sleep stage information can be used to activate sleep-enhancing white / pink noise and / or binaural beats. These can be generated by an audio device embedded in the patient interface 6000 itself, or by an external device that receives a trigger signal from the patient interface 6000 via a processor / transceiver 6350. For example, one or more miniature bone conduction speakers can be incorporated into the temple area of ​​the upper textile portion 6310.

[0315] In some forms of this technology, the positioning and stabilization structure 6300 may incorporate electromyography (EMG) and / or electrooculography (EOG) sensors. EMG and EOG sensor signals can be analyzed to determine the occurrence of REM sleep stages. In a manner similar to the example incorporating EEG sensors, the sleep stage information determined by the EMG / EOG sensors can be used to provide feedback to the patient regarding the progress of sleep therapy, and can also be used to adjust the pressure generator 4140 to avoid awakening or blocking events, or to activate one or more audio devices to generate sleep-enhancing noise.

[0316] At least some EMG / EOG sensors can be incorporated into the upper textile portion 6310. For example, a ground electrode and a reference electrode can be disposed in the upper textile portion 6310, for example, in its anterior section, and exposed through corresponding holes in the inner layer 6370 to allow contact with the patient's forehead. In another instance, the ground electrode can be disposed in the rear portion 6306 of the upper textile portion 6310, or in the second lower textile portion 6308, such that the ground electrode is located behind the patient's ear in use. Additional electrodes can be provided, each having a cable attached at one end to and extending within the upper textile portion 6310, the first lower textile portion 6320, or the second lower textile portion 6308, and at the other end to an electrode patch that can be positioned by the patient on the temples and below their eyes to provide two additional measurement channels.

[0317] In some forms of this technology, acoustic sensors, such as microphones, including MEMS microphones or electret microphones, or piezoelectric thin-film-based transducers, can be incorporated into the patient interface 6000 to detect snoring. For example, the microphone may be located in or on the inner surface of the air chamber 6200, or on its outer surface, adjacent to the patient's nostrils. The microphone may be coupled to a communication interface to enable data transmission to the pressure generator 4140 of the RPT device 4000 to adjust the resulting pressure. For example, when a mild snoring noise pattern is detected, the treatment pressure may be gradually increased to prevent obstruction events. When the snoring noise pattern decreases, the treatment pressure may be gradually decreased.

[0318] In some forms of this technology, the patient interface 6000 may incorporate humidity and temperature sensors, for example, on the inner surface of the inflation chamber 6200, to monitor the temperature and humidity inside the inflation chamber 6200. The sensors may be coupled to a communication interface for transmitting humidity and temperature data to the RPT device 4000 and humidifier 5000 to regulate their operation. The power of the pressure generator 4140 and humidifier 5000 may be adjusted to prevent condensation buildup. For example, the humidifier 5000 may be activated in stages, and / or the heater power level may be controlled, followed by flushing with normal air while still maintaining a sufficient humidity level (measured by the humidity sensor) to prevent dry mouth.

[0319] In some forms of this technology, a pressure sensor may be disposed inside the inflation chamber 6200, for example, on its inner surface. This allows the air pressure inside the inflation chamber 6200 to be monitored, and the signal is sent to the pressure generator 4140 to dynamically adjust the pressure and flow rate. This can optimize the response of the pressure generator 4140 to the patient's breathing pattern.

[0320] In some forms of this technology, a CO2 sensor can be installed inside the inflation chamber 6200. For example, the CO2 level inside the inflation chamber 6200 can be monitored. When a slight increase in the CO2 level is detected, an electromechanical vent (not shown) can be opened to allow higher flushing air from the inflation chamber 6200. Furthermore, when the CO2 level increases slightly, a signal can be sent to the pressure generator 4140 to slightly increase the flow rate of flushing CO2. This can be done dynamically to minimize patient discomfort.

[0321] In some forms of this technology, a combination of sensors and actuators can be provided to achieve localized temperature changes, thereby improving patient comfort. For example, an EEG sensor and / or pulse oximeter can be disposed in the upper textile portion 6310 (e.g., with...). Figure 8 (as shown in 6354), and the temperature sensor and / or humidity sensor can also be disposed in the upper textile part 6310 (e.g., as shown in 6354). Figure 9C (As shown in 6358). Signals from EEG and / or PPG sensors can be analyzed to detect sleep state, and signals from temperature and / or humidity sensors can be used to assess environmental comfort level. One or more Peltier elements can be provided, for example in a wearable form on a wristband, and can be coupled to circuitry communicating with the EEG / PPG and temperature / humidity sensors to receive signals indicating sleep state and environmental comfort level, and to activate the Peltier elements to locally heat or cool the body (e.g., at the wrist) to help the patient maintain a comfortable sleep state.

[0322] In some forms of this technology, haptic feedback elements (such as miniature vibration motors) can be incorporated into the patient interface 6000, for example, in the temple region of the positioning and stabilization structure 6300 (e.g., the temple region of the upper textile portion 6310). The haptic feedback elements can transmit vibrations to the patient to produce a calming effect. For example, the processor module 6350 can monitor heart rate data from the pulse oximeter 6354 and, if the heart rate data exceeds a threshold, transmit a trigger signal to the haptic feedback element to cause it to vibrate at a frequency several beats lower than the patient's current heart rate, thereby helping to slow the heart rate. In another example, as described above, if a patient is detected to be in a sleep posture associated with an apnea or hypopnea event, the haptic feedback element can be used to influence the patient's sleep posture.

[0323] In some forms of this technology, one or more miniature thermoelectric generators (TEGs) can be incorporated into the patient interface 6000, such that the difference between the patient's body temperature and the ambient temperature can be used to generate a potential difference and thus provide power to various electronic components (sensors, actuators, processors, etc.) of the patient interface 6000. For example, the miniature TEGs can be located in the upper textile portion 6310 and exposed through holes in the inner layer 6370, allowing them to contact the patient's forehead.

[0324] In some forms of this technology, multiple sensors can be combined into a single module. For example, an accelerometer and a gyroscope can be combined into a single package.

[0325] Although various sensors and actuators have been described as being combined in Figure 7A , Figure 7B and Figure 8 The patient interfaces 6000 shown herein are examples of such interfaces, but it should be understood that they can be incorporated in a similar manner into any other patient interface 3000 disclosed herein.

[0326] Power system for patient interface and headband

[0327] As described above, the patient interface 3000 or 6000 and / or the positioning and stabilization structure for the patient interface (also referred to herein as a headband) may include one or more electronic components, such as sensors, actuators, processors, etc. These components may be integrated into the patient interface 3000 or 6000, for example as... Figure 8 One or more actuator modules 6354 to 6360 are shown.

[0328] As discussed, one or more electronic components may be powered by an energy storage device such as a rechargeable battery or a supercapacitor. In some forms of this technology, the patient interface may include and / or be able to communicate with an electrical system that can directly power one or more electrical components and / or charge batteries or supercapacitors that do so.

[0329] Figure 9A This is a schematic block diagram of a patient interface 7000, which includes one or more electronic components powered by an electrical system. The patient interface 7000 includes a battery 7020 (e.g., a rechargeable battery), a communication module 7030, and two sensor modules 7040 and 7050. Each sensor module 7040, 7050 may include multiple sensor components. For example, sensor module 7040 may include temperature, humidity, ambient light, and / or acoustic sensors incorporated therein. For example, sensor module 7050 may include an accelerometer, a gyroscope, a pulse oximeter, and / or a blood pressure sensor. Any of these sensor components may alternatively be included on another sensor, or may be included separately on an additional sensor (not shown). Additionally, other sensor components not explicitly mentioned above may be included in at least one sensor 7040, 7050, and / or a separate sensor. Communication module 7030 may include one or more of a Bluetooth interface, a near-field communication (NFC) interface, and a WiFi interface. The patient interface 7000 may include a positioning and stabilization structure based on the positioning and stabilization structure of the patient interface 3000 or the patient interface 6000, and the sensors of modules 7040 and 7050 may include any sensors described above with reference to the patient interface 6000.

[0330] Battery 7020 supplies power to one or more of modules 7030, 7040, and 7050 via power line 7072 and ground line 7070. Modules 7030, 7040, and 7050 are synchronized with each other via clock signal 7076 and transmit data to each other via data line 7074.

[0331] In some instances, such as Figures 9A to 9D As shown, the power system may include a charger circuit 7010 located outside the patient interface 7000, but may communicate with the rechargeable battery 7020 of the patient interface 7000 in a wired or wireless manner. For example, the charger circuit 7010 may form part of or communicate with the RPT device 4000.

[0332] In one instance, such as Figure 9BAs schematically depicted, charger circuitry 7010 is connected to rechargeable battery 7020 via a wired connection. For example, a power cable may be wound (spirally or otherwise) around the outside of air circuit 4170, allowing its ends to be connected to terminals of battery 7020. A data cable may also be wound around the outside of air circuit 4170 (e.g., within an insulating extrusion) for connection to battery 7020 and / or any other modules 7030, 7040, 7050. Alternatively, data may be communicated between battery 7020 and charger circuitry 7010 via other means (such as Bluetooth or NFC), mediated, for example, by communication module 7030.

[0333] In some forms of this technology, power and / or data cables may pass through conduits located on the outer surface of the air circuit 4170 or even within the air circuit 4170.

[0334] The data connection between the charging circuit 7010 and the battery 7020 can be used to control the charging of the battery 7020 in various ways. For example, a charging algorithm can be implemented in the battery 7020 such that when a certain low battery threshold is reached, the battery 7020 sends an alarm to the charging circuit 7010 to initiate charging. The battery 7020 can also wirelessly transmit charging information (and other information) to other nearby devices.

[0335] The connection of the power and / or data cable extending from the charging circuit 7010 to the patient interface 7000 can be implemented in various ways. For example, the cable can terminate at one end of an air circuit 4170, which is connected via a slip ring to an electrical contact of an air inlet connection port (such as port 3600 of patient interface 3000 or port 6600 of patient interface 6000), and the terminal at the port can be electrically connected in turn to the battery 7020 or other electrical components of the patient interface 7000. This allows the electrical connection to be maintained when the end of the air circuit 4170 is rotated within the port.

[0336] In some forms of this technology, such as Figure 9CAs shown, the charger circuit 7010 can be configured to charge the battery 7020 via a wireless power transfer method. For example, near-field wireless power transfer can be implemented by an inductive charging circuit of the charger circuit 7010, which cooperates with a charging coil located in another part of the headband or patient interface 7000. The inductive charging circuit can be located in the RPT device 4000, for example, allowing the patient to place the headband on the RPT device 4000 when not in use to charge the headband's rechargeable battery. In some forms, the patient interface 7000 may include a female alignment member for automatically aligning the battery 7020 with the charging circuit 7010. For example, the magnetic alignment member may include one or more magnets attracted by a magnetic field generated by the RPT device 4000, such as by one or more magnets near the location of the charging circuit 7010. Alternatively, the charging circuit 7010 may use a far-field or radiated wireless power transfer method (such as WiFi-based power transfer) to charge the battery 7020. Data can be transferred from the battery 7020 to the charging circuit 7010 via Bluetooth, NFC, etc.

[0337] In some forms of this technology, such as Figure 9D As shown, the charger circuit 7010 can be connected to the battery 7020 via any form of standard connection (such as a USB-C or mini-USB cable 7080). Therefore, while the charger circuit 7010 can be used to charge the battery 7020, other standard charging devices independent of the RPT device 4000 (such as smartphone chargers) can also be used to charge the battery 7020. In these forms, the patient interface 7000 can be made substantially independent of the RPT device 4000 for the purpose of powering the electronic components of the patient interface 7000. Therefore, the portability of the patient interface 7000 is improved if the patient interface (or at least its headband) is used only for monitoring purposes and not for treatment purposes. Figure 9B and Figure 9C As shown, data can be transmitted to the charger circuit 7010 via Bluetooth, NFC, etc., as needed.

[0338] In some forms of this technology, the power system may include an energy harvesting system. This energy harvesting system is arranged to convert non-electrical energy (such as mechanical or thermal energy) generated during the use of the patient interface into electrical energy for powering one or more electrical components. Advantageously, the energy harvesting system provides an alternative or additional energy source for powering one or more electrical components, and / or for providing auxiliary power when the energy storage device is at low capacity. Furthermore, the energy harvesting system can reduce the need to recharge the batteries or supercapacitors powering one or more electronic components.

[0339] For example, such as Figure 10As shown, it illustrates having with Figure 9A The patient interface 7000' has the same general configuration as the patient interface 7000'. However, in Figure 10 In this embodiment, the patient interface 7000' is not connected to any external power source, but is integrated with an energy harvesting system 7060. The energy harvesting system 7060 is electrically coupled to a battery 7020 and electronic modules 7030, 7040, and 7050. The energy harvesting system 7060 can directly power modules 7030, 7040, and 7050 and / or charge the battery 7020, allowing the battery 7020 to provide power to the modules.

[0340] Of course, it should be understood that in some forms of this technology, the patient interface may include an energy harvesting system 7060 and be configured to communicate with an external charging circuit 7010 to charge the battery 7020.

[0341] In one embodiment of this technology, a turbine generator can be disposed in the airflow path of the patient interface. The turbine generator is constructed and arranged to convert mechanical energy from the airflow into electrical current during use of the patient interface. For example, the turbine generator can be located at the air inlet of patient interfaces 3000, 6000 (e.g., and can rotate due to pressurized air flowing towards the patient). In some embodiments of this technology, the turbine generator is located within connection port 3600 or 6600 connecting patient interfaces 3000, 6000 to air circuit 4170. By doing so, the turbine generator receives the highest possible airflow and can therefore generate the highest possible current. Alternatively, the turbine generator can be located within decoupling structure 3500. In some embodiments of this technology, the turbine generator can be positioned in a straight line with the vent of patient interfaces 3000, 6000, or can be part of the vent of patient interfaces 3000, 6000. In some embodiments, the vent and turbine generator can be located upstream of the patient, such that pressurized air flows through the vent and turbine generator. In other configurations, the ventilation port and turbine generator can be positioned downstream of the patient (e.g., a ventilation port that vents exhaled air into the surrounding environment).

[0342] In one configuration, the turbine generator may be located at the air inlet of the patient interface 3000, 6000 or in a connection port 3600, 6600 that is substantially perpendicular to the direction of pressurized air flow. For example, the turbine generator may rotate about an axis that is substantially parallel to the direction of pressurized air flow.

[0343] In another configuration, multiple turbine generators may be positioned within the air inlets and / or connection ports 3600 and 6600 of patient interfaces 3000 and 6000. The turbine generators may be spaced apart from each other along the flow path of the pressurized air.

[0344] One form of the 8000 turbine generator is in Figures 11A to 11D As shown in the diagram, the turbine generator 8000 includes a rotor assembly 8100 configured and arranged to rotate about a shaft 8200 within a stator assembly, the stator assembly including an internal portion 8300 housed in a housing 8400 and sealed by a cover 8500. The cover 8500 is assembled with the housing 8400 to seal the coil windings 8310, thereby protecting them from the ingress of moisture and particulate matter.

[0345] The end of shaft 8200 is received in a corresponding hole 8510 of cover 8500 and a corresponding hole 8330 of inner portion 8300, allowing rotor 8100 to rotate within stator assembly. Shaft 8200 may form a friction fit with holes 8510 and 8330 and a clearance fit with hole 8120 extending through rotor assembly 8100. Alternatively, shaft 8200 may form a friction fit with rotor hole 8120 and a clearance fit with holes 8330 and 8510 to provide the ability of rotor assembly 8100 to rotate.

[0346] In some configurations, the shaft can be configured to be supported at only one end, like a cantilever. This arrangement helps to confine the support rib elements (e.g., rib 8520) to one side of the energy harvester to reduce noise.

[0347] In some forms, the internal portion 8300 includes a plurality of spools 8308 extending around its periphery (see, for example, Figure 11A Each spool 8308 has a cylindrical section around which a conductor can be wound to form a coil of windings for a stator assembly. Although in other instances, at least one spool 8308 may have a different shape (e.g., having an angled shape or an elliptical periphery).

[0348] In some forms of this technology, a single-wire winding scheme is employed to maximize the generated voltage. A single strand of wire is first wound multiple turns around one spool 8308, then multiple turns around the next spool 8308, continuing from one spool 8308 to the next, with the turns of the continuous coil 8310 facing opposite directions. For example... Figure 11C As shown, once all the coils are wound, the wires may have a first end 8312 and a second end 8314, which may pass through the stator housing 8400 to be connected to one or more electronic components, for example via additional circuitry of a rectifier circuit and / or a voltage regulator circuit. In some forms of this technology, the rectifier circuit and / or voltage regulator circuit may be located within the housing of the turbine generator 8000, for example, within housing 8400.

[0349] In other forms, instead of a single strand of wire wound around all the spools 8308, two or more strands of wire can be wound around the spools 8308 in series and / or parallel configurations to obtain the desired voltage and current output.

[0350] The circuit can be connected to terminals extending from or located on the outer surface of the turbine generator 8000 to contact terminals located within the patient interface 3000 or 6000, and can be electrically connected to one or more electronic components. For example, terminals located within the patient interface can be connected to wires or other conductors within and / or extending along the conduit 3301 of the patient interface 3000 or the upper textile portion 6310 or lower textile portion 6320 of the patient interface 6000.

[0351] In some forms of this technology, fine-gauge wire can be used to form the stator coils to accommodate as many turns as possible, thereby generating the highest possible voltage. For example, 0.1 mm wire can be used. In another instance, 0.22 mm wire can be used. In this way, voltages higher than 5 volts can be generated, making the boost converter unnecessary for the operation of one or more electronic components of the patient interface 3000, 6000.

[0352] Rotor assembly 8100 includes a generally cylindrical rotor body with a rotor bore 8120 extending therethrough. In some forms, the rotor bore 8120 may extend through the center of the cylindrical rotor body, although in other instances, the rotor bore 8120 may be off-center. The rotor body includes a plurality of turbine blades 8130. It should be understood that the shape (angle and profile) and number of blades 8130 can be optimized to ensure low-noise operation during respiratory therapy when pressurized air causes rotor 8100 to rotate (e.g., as pressurized air enters the inlet of patient interfaces 3000, 6000 via air circuit 4170 and / or exhaled air exits from the patient's nostrils or mouth). For example, the angle of attack of blades 8130 may be configured such that the torque generated by rotor assembly 8100 is sufficient to overcome the forces associated with the induced magnetic field from the coils of the stator and sufficient to generate the required voltage.

[0353] The rotor body also includes multiple peripheral recesses 8110, in which corresponding magnets can be held. Once the magnets are inserted, the recesses 8110 can be sealed to prevent dust and moisture from entering.

[0354] In some forms of this technology, the magnets of adjacent recesses 8110 have opposite magnetic poles facing the winding. The number of coil spools 8308 can be the same as the number of magnets, and their angular pitch can also be the same. The coil spools and magnet spools can each be arranged radially. In some instances, the magnet spools can be arranged radially, while the coil spools can be arranged tangentially.

[0355] like Figure 11E As shown, an alternative form of the rotor body 9000 may have magnets 9004, which are positioned toward the base of the blade 9008 (instead of at the base). Figure 11A and 11B (In the recess 8110 near the periphery of the rotor shown). In some forms, the magnets 9004 of the rotor body 9000 may be similarly positioned in the recess (e.g., such that they are removable) and / or they may be fixed to the housing 9002 or other parts of the rotor body 9000.

[0356] In some forms, magnet 9004 can be covered, similar to the magnet in the recess described above, in order to limit the entry of dust and moisture.

[0357] In some forms, the magnet 9004 is arranged in a configuration similar to that described in the insertion recess 8110. For example, the magnets 9004 of adjacent blades 9008 have opposite magnetic poles facing the stator coil 9012.

[0358] In some forms, the stator coil 9012 of the rotor body 9000 can be embedded in the rotor body 9000. The stationary coil 9012 can serve as a stationary shaft about which the rotor 9000 rotates. The coil 9012 can be formed from one or more strands of wire as described above.

[0359] In some configurations, the magnet 9004 is positioned closer to the base of the turbine blade 9008, such as... Figure 11E As shown, lower rotor inertia can be generated (e.g., the center of mass is positioned closer to the center of the rotor body 9000), and therefore, better rotation is possible even under relatively low airflow conditions (e.g., less torque is required to generate rotation in the turbine blades 9008).

[0360] To assemble the turbine generator 8000, the inner portion 8300 is placed within the housing 8400, and then the rotor assembly 8100 is placed within the inner portion 8300. The shaft 8200 can then be inserted into the through-hole 8120 of the rotor assembly 8100 and into the hole 8330 of the inner portion. At this stage, the stator assembly coils 8310 remain exposed. Therefore, the cover 8500 is then attached to the housing 8400 such that the shaft 8200 is located in the hole 8510 of the cover, and the rim 8530 of the cover seals the space where the coils 8310 reside. The cover 8500 can be secured to the housing 8400 by any suitable means, such as by snap-fit ​​or thread. In some forms of this technology, a gasket (not shown) may be provided at the rim 8530 to further reduce the possibility of moisture ingress.

[0361] Because both the rotor assembly 8100 and the stator assembly (including the combination of the housing 8400, internal portion 8300, and cover 8500) are sealed, the ingress of moisture and dust is minimized. Therefore, the turbine generator can remain in place within the patient interfaces 3000 and 6000 during the normal cleaning cycle of the patient interfaces. This is more convenient for patients as it eliminates the need for disassembly.

[0362] As described above, the turbine generator 8000 operates by converting mechanical energy from an airflow into rotational energy, which is then converted into electrical energy by the current induced in the coil 8310 by the rotating magnet of the rotor 8100. For this purpose, it is desirable to minimize flow resistance. In some forms of this technology, this is achieved by providing a support structure with minimal surface area for the shaft 8200. For example, as... Figures 11A to 11D As shown, the shaft 8200 can be supported on the side of the cover 8500 by three ribs 8520 extending from the central ring 8515 to the rim 8530 of the cover 8500.

[0363] In some forms of this technology, two ribs 8520 can extend from the center ring 8515 to the rim 8530. In other forms, more than three ribs 8520 may be provided. Generally, it may be advantageous to provide an odd number of ribs 8520 if the number of blades 8130 is even (and vice versa), as this provides asymmetry that will tend to reduce the amount of noise generated when the blades 8130 pass over the ribs 8520.

[0364] Rib 8520 is manufactured as thin as possible to minimize flow resistance while still providing necessary support for the shaft. As shown, rib 8520 does not extend radially from ring 8515 but is slightly offset. This is to reduce the likelihood of turbulence being generated when air flows over turbine generator 8000, thereby reducing the amount of noise generated. The offset arrangement of rib 8520 tends to guide airflow, thus smoothing it, for example, by changing the direction of airflow or by reducing the speed of airflow, thereby reducing the amount of turbulence and thus causing more laminar flow. For example, further smoothing of airflow can be achieved by providing curved or angled surfaces for rib 8520.

[0365] Similar to the cover 8500, the internal part 8300 of the stator assembly can have a support structure with minimal surface area, such as ribs 8320 in groups of three, which have a configuration that is essentially the same as that of the ribs 8520 of the cover 8500.

[0366] The turbine generator 8000 can be connected to circuitry for modulating and / or converting its output voltage before it is connected to one or more electronic components connected to the patient interfaces 3000 and 6000. For example, a full-bridge rectifier with capacitors can be used to convert the output AC voltage to DC power.

[0367] Test results using an 8-blade, 8-pole configuration as an example show that, under a 20cm H2O pressure setting, when the turbine generator is placed in the air circuit 4170 connected to the RPT device 4000, it can generate a voltage of up to 8V.

[0368] In some forms of this technology, the energy harvesting system may include at least one piezoelectric film. The piezoelectric film can be used to generate an electric current during use from changes in airflow (e.g., due to the input of pressurized air, for example, from the RPT device 4000 and / or from the patient's exhalation) and the patient's body movements. The deflection of the piezoelectric film generates a voltage that depends on the deflection amplitude and velocity. Advantageously, the piezoelectric film itself can also be used as a sensor, where the voltage output indicates vibration and / or noise (e.g., due to snoring).

[0369] The piezoelectric film can be placed within or on various components of the patient interface 3000, 6000. For example, the piezoelectric film can be positioned within the inflation chamber 3200, 6200, such as adjacent to the air inlet of the inflation chamber, so that it is in the path of the airflow generated by the RPT device 4000 during use. Such a positioned piezoelectric film can be used to harvest energy and detect vibrations. In another example, the piezoelectric film can be attached to or integrated with the inner surface of the sealing structure 3100 for energy harvesting and motion sensing. In yet another example, the piezoelectric film can be attached to or sandwiched between layers of straps or bandages on the positioning and stabilizing structures 3300, 6300 or another component in contact with the user's face, such that movement of the user's facial muscles during breathing or other movements causes the piezoelectric film to bend and thus generate electrical energy. In another example, the piezoelectric film may be positioned within the inflation chambers 3200, 6200, for example, adjacent to the outlet of the inflation chamber (e.g., a vent for exhaled air to be discharged into the surrounding environment), such that it is in the path of the exhaled air (e.g., carbon dioxide) leaving the inflation chamber.

[0370] In some forms, the patient interfaces 3000, 6000 may include a turbine generator 8000 and a piezoelectric film (e.g., opposite to one or the other). This can allow for greater energy harvesting and / or allow for energy harvesting at multiple locations in the flow path.

[0371] In some forms of this technology, the energy harvesting system may include one or more thermoelectric generators (TEGs). The thermoelectric generators can be used to convert thermal energy into electrical energy, which can then be used to power various electrical components of the patient interface 3000, 6000.

[0372] In some forms, the thermoelectric generator may be located on the portion of the patient interface 3000, 6000 suitable for contact with the patient during use. For example, the thermoelectric generator may be located on a portion of the positioning and stabilizing structures 3300, 6300. The thermoelectric generator can utilize heat emitted from the patient's skin and convert it into electrical energy. The thermoelectric generator may alternatively or additionally be located on the sealing forming structures 3100, 6100, and similarly capture heat emitted from the patient's skin.

[0373] Alternatively or additionally, a thermoelectric generator may be located in the inflation chamber 3200, 6200 of the corresponding patient interface 3000, 6000. The thermoelectric generator can convert heat from exhaled air into electrical energy, which can be used to power various electrical components.

[0374] Figure 12A and Figure 12B An example of measurements recorded by two piezoelectric films, which form part of an energy harvesting system that forms a patient interface, is shown. The first piezoelectric film is positioned within the air path near the inlet of the air chamber 3200, and the second piezoelectric film is positioned along the inner surface of the sealing structure 3100.

[0375] exist Figure 12A In the study, the patient's breathing pattern consisted of a series of normal breaths, followed by respiratory arrest, and then sudden inhalation. Respiratory arrest was detectable as a deviation from the normal breathing pattern because the average amplitude of the piezoelectric film along the air path was zero during the arrest. Sudden inhalation was detectable as a spike in the signal detected by the piezoelectric film of the gasket (sealing-forming structure).

[0376] In some forms, this can allow piezoelectric film-based collectors to be used as snoring and / or cessation of breathing detectors (i.e., detecting cessation of breathing).

[0377] exist Figure 12B The image shows a series of normal breathing movements followed by simulated snoring. During the snoring phase, the signal detected by the piezoelectric film in the air path remains unchanged, but a spike appears in the signal detected by the piezoelectric film in the liner.

[0378] Vent

[0379] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0380] In some configurations, the airway 3400 is configured to allow continuous airflow from the interior of the inflation chamber 3200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 3400 is configured such that the airflow rate is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining the therapeutic pressure within the inflation chamber during use.

[0381] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0382] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a decoupling structure, such as a rotating shaft.

[0383] As described above, one or more of the energy harvesters described above (e.g., turbine generator 8000, piezoelectric film and / or thermoelectric generator) can be positioned near the vent 3400 in order to convert the flushing gas into electrical energy.

[0384] In some configurations, the energy harvester may be positioned within an inflatable chamber 3200, 6200, between the patient and the airway 3400. In other words, the patient may be upstream of the energy harvester, and the airway 3400 downstream. As described above, exhaled CO2 can be expelled through the airway 3400 to prevent rebreathing. As air flows from the patient's mouth to the airway 3400, the air passes through the energy harvester, allowing some energy to be recaptured.

[0385] In some configurations, the ventilation port of the patient interface 3000 or 6000 can be an exhaust port, which can discharge pressurized air into the surrounding environment before reaching the patient (i.e., this can be a different ventilation port than the CO2 exhaust port mentioned above). For example, Figure 1C The full-face mask 3000 shown and Figure 1B and Figure 3A The nasal mask shown can be connected to the same RPT device 4000. In some versions, the RPT device 4000 may include sensors or user input to determine which version of the mask is connected. In other versions, the RPT device 4000 can provide a single output for a given pressure. In other words, to obtain a given pressure in the corresponding inflation chamber, the RPT device can output a defined pressure regardless of which patient interface is connected.

[0386] In some configurations, the volume of the inflation chamber 3200 of the full-face mask 3000 may be larger than the volume of the inflation chamber 3200 of the nasal mask 3000. Therefore, the inflation chamber 3200 of the nasal mask may be over-inflated (e.g., experiencing higher pressure than required). To address this issue, the vent 3400 may be located within the rotating shaft, allowing air to be released into the surrounding environment before entering the inflation chamber 3200. This allows the pressure within the inflation chamber 3200 to drop to the desired pressure.

[0387] Using the exhaust port in this way may be inefficient, as the electrical energy required to generate a stronger flow may be wasted (i.e., pressurized air is released into the surrounding environment before the patient can inhale it). The turbine generator 8000 (as described above) can be positioned near the shaft and can supplement and / or replace the exhaust port.

[0388] For example, the airflow through the turbine generator 8000 can reduce the velocity of the pressurized airflow, thereby reducing the airflow pressure. This can reduce the airflow pressure to the desired pressure and / or require less airflow to be discharged through the vent.

[0389] In some configurations, energy harvesters may be used in conjunction with the vent 3400 and the exhaust port to improve system efficiency (e.g., to recapture more energy that would otherwise leave the system). However, patient interfaces 3000 and 6000 may include only one of these energy harvesters or none at all.

[0390] Decoupling structure

[0391] In one form, the patient interface 3000 includes at least one decoupling structure, such as a spindle or ball head and ball socket.

[0392] Connection port

[0393] Connection port 3600 allows connection to air circuit 4170.

[0394] Forehead brace

[0395] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0396] Anti-asphyxiation valve

[0397] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0398] port

[0399] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the pneumatic chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the pneumatic chamber 3200, such as pressure.

[0400] RPT device

[0401] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate an airflow for delivery to a patient's airway, for example, for treating one or more respiratory conditions described elsewhere in this document.

[0402] In one embodiment, the RPT device 4000 is constructed and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0403] The RPT device may have an outer housing 4010, which is composed of two parts: an upper part 4012 and a lower part 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0404] The pneumatic path of the RPT device 4000 may include one or more air path components, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow rate sensor 4274.

[0405] One or more air path components may be housed within a detachable, separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer housing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0406] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the RPT device 4000 may include more than one PCBA 4202.

[0407] RPT device mechanical and pneumatic components

[0408] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be configured as separate units.

[0409] air filter

[0410] One form of RPT device according to the present technology may include an air filter 4110, or a plurality of air filters 4110.

[0411] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0412] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0413] muffler

[0414] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0415] In one embodiment of this technology, the inlet silencer 4122 is positioned in the pneumatic path upstream of the pressure generator 4140.

[0416] In one embodiment of this technology, the outlet silencer 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0417] pressure generator

[0418] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower can deliver an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, for example, when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application No. WO 2013 / 020167.

[0419] The pressure generator 4140 can be controlled by the treatment device controller 4240.

[0420] In other words, the pressure generator 4140 can be a piston-driven pump, a pressure regulator (e.g., a compressed air reservoir) connected to a high-pressure source, or a bellows.

[0421] A pressure generator may also be referred to as a flow generator in at least some contexts.

[0422] transducer

[0423] The transducer can be inside or outside the RPT device. An external transducer can be located, for example, on or form part of an air circuit such as a patient interface. The external transducer can 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.

[0424] In one embodiment of this technology, one or more transducers 4270 may be positioned upstream and / or downstream of pressure generator 4140. The one or more transducers 4270 may be configured and arranged to generate a signal representing airflow characteristics such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0425] In one embodiment of this technology, one or more transducers 4270 may be positioned proximal to the patient interface 3000 or 3800.

[0426] In one embodiment, the signal from transducer 4270 may be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0427] Flow rate sensor

[0428] The flow sensor 4274 according to this technology can be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from SENSIRION.

[0429] In one configuration, the signal generated by the flow velocity sensor 4274, which represents the flow velocity, is received by the central controller 4230.

[0430] pressure sensor

[0431] The pressure sensor 4272 according to this technology is located in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the Honeywell ASDX series. Another suitable pressure sensor is a transducer from the General Electric NPA series.

[0432] In one configuration, the signal generated by pressure sensor 4272 and representing pressure is received by central controller 4230.

[0433] Motor speed transducer

[0434] In one embodiment of this technology, a motor speed transducer 4276 is used to determine the rotational speed of the electric motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer 4276 can be provided to the treatment device controller 4240. The motor speed transducer 4276 can be, for example, a speed sensor, such as a Hall effect sensor.

[0435] Anti-overflow valve

[0436] In one embodiment of this technology, a backflow valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the electric motor 4144.

[0437] RPT device electrical components

[0438] power supply

[0439] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0440] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000. In yet another embodiment of this technology, power supply 4210 supplies power to one or more electronic components of patient interfaces 3000 and 6000.

[0441] Input device

[0442] In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow personnel to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessed via a touchscreen. In one form, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another form, they can communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0443] In one form, the input device 4220 may be configured or arranged to allow a person to select values ​​and / or menu options.

[0444] Central controller

[0445] In one form of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000.

[0446] Suitable processors may include x86 Intel processors, based on those from ARM Holdings. Processors with an M-bit RISC CPU, such as the STM32 series microcontrollers from ST Microelectronics, are also suitable. In some alternative forms of this technology, processors with a 32-bit RISC CPU, such as the STR9 series microcontrollers from ST Microelectronics, or a 16-bit RISC CPU, such as the MSP430 series microcontrollers from Texas Instruments, are equally applicable.

[0447] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0448] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.

[0449] The central controller 4230 can be configured to receive input signals from one or more transducers 4270, one or more input devices 4220, and humidifier 5000.

[0450] The central controller 4230 can be configured to provide output signals to one or more of the output device 4290, the treatment device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0451] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that can be implemented using processor control instructions, which are represented as a computer program stored in a non-transitory computer-readable storage medium (such as memory 4260). In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remote positioning device. For example, the remote positioning device may determine the control settings of the ventilator or detect respiratory-related events by analyzing stored data from, for example, any sensors described herein.

[0452] clock

[0453] RPT device 4000 may include a clock 4232 connected to central controller 4230.

[0454] Treatment device controller

[0455] In one form of this technology, the treatment device controller 4240 is a treatment control module 4330, which constitutes part of the algorithm 4300 executed by the central controller 4230.

[0456] In one embodiment of this technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0457] Protection circuit

[0458] One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0459] memory

[0460] According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260, such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0461] The memory 4260 may be located on PCBA 4202. The memory 4260 may be in the form of EEPROM or NAND flash memory.

[0462] Additionally or alternatively, the RPT device 4000 includes a removable memory 4260, such as a memory card manufactured according to the Secure Digital (SD) standard.

[0463] In one form of this technology, memory 4260 is used as a non-transitory computer-readable storage medium storing computer program instructions representing one or more methods described herein, such as one or more algorithms 4300.

[0464] Data communication system

[0465] 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 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0466] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0467] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0468] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0469] In one form, the remote external device 4286 can be one or more computers, such as a cluster of networked computers. In another form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, this remote external device 4286 can be accessed by appropriately authorized personnel, such as clinicians.

[0470] The local external device 4288 can be a personal computer, mobile phone, tablet, or remote control device.

[0471] Includes output devices for optional displays and alarms.

[0472] The output device 4290 according to this technology can take the form of one or more of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0473] Display driver

[0474] The display driver 4292 receives characters, symbols, or images as input for display on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0475] monitor

[0476] Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals indicating whether the eight corresponding segments will be activated to display a specific character or symbol.

[0477] RPT device algorithm

[0478] As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transient computer-readable storage medium (such as memory 4260). The algorithms 4300 are generally grouped into groups called modules.

[0479] In other forms of this technology, some or all of the algorithm 4300 may be implemented by the controller of an external device, such as a local external device 4288 or a remote external device 4286. In this form, the input signals and / or intermediate algorithm outputs required to represent the portion of the algorithm 4300 to be executed at the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In this form, the portion of the algorithm 4300 to be executed at the external device may be represented as a computer program stored in a non-transient computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute portions of the algorithm 4300.

[0480] In this configuration, treatment parameters generated by an external device via the treatment engine module 4320 (if thus forming part of the algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 for transfer to the treatment control module 4330.

[0481] Preprocessing module

[0482] According to one form of the present technology, a preprocessing module 4310 receives a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272) as input and performs one or more processing steps to calculate one or more output values ​​that will be used as input to another module (e.g., a treatment engine module 4320).

[0483] In one form of this technology, the output values ​​include interface pressure Pm, ventilation flow rate Qv, breathing flow rate Qr, and leakage flow rate Ql.

[0484] In various forms of this technology, the preprocessing module 4310 includes one or more of the following algorithms: interface pressure estimation 4312, ventilation velocity estimation 4314, leakage velocity estimation 4316, and respiratory velocity estimation 4318.

[0485] Interface stress estimation

[0486] In one form of this technology, the interface pressure estimation algorithm 4312 receives a signal from pressure sensor 4272 representing the pressure (device pressure Pd) in the pneumatic path near the pneumatic block outlet and a signal from flow velocity sensor 4274 representing the flow velocity (device velocity Qd) of the airflow leaving the RPT device 4000 as inputs. The device velocity Qd without any supplementary gas 4180 can be used as the total flow velocity Qt. The interface pressure algorithm 4312 estimates the pressure drop ΔP through the air loop 4170. For a given air loop 4170, the dependence of the pressure drop ΔP on the total flow rate Qt can be modeled using the pressure drop characteristic ΔP(Q). The interface pressure estimation algorithm 4312 then provides an estimated pressure Pm as output in the patient interface 3000 or 3800. The pressure Pm in the patient interface 3000 or 3800 can be estimated as the device pressure Pd minus the air loop pressure drop ΔP.

[0487] Ventilation velocity estimation

[0488] In one embodiment of this technology, the ventilation velocity estimation algorithm 4314 receives the estimated pressure Pm in the patient interface 3000 or 3800 as input from the interface pressure estimation algorithm 4312, and estimates the ventilation velocity Qv of the air from the vent 3400 in the patient interface 3000 or 3800. For a specific vent 3400 in use, the dependence of the ventilation velocity Qv on the interface pressure Pm can be modeled by the ventilation feature Qv(Pm).

[0489] Leakage velocity estimation

[0490] In one form of this technology, the leakage velocity estimation algorithm 4316 receives the total flow velocity Qt and the ventilation velocity Qv as inputs and provides an estimate of the leakage velocity Ql as output. In another form, the leakage velocity estimation algorithm estimates the leakage velocity Ql by calculating the average of the difference between the total flow velocity Qt and the ventilation velocity Qv over a sufficiently long time period that includes several breathing cycles (e.g., about 10 seconds).

[0491] In one form, the leak flow rate estimation algorithm 4316 receives the total flow rate Qt, ventilation flow rate Qv, and estimated pressure Pm from the patient interface 3000 or 3800 as input, and provides the leak flow rate Ql as output by calculating the leak conductivity and determining the leak flow rate Ql as a function of the leak conductivity and pressure Pm. The leak conductivity is calculated as the quotient of the low-pass filtered non-ventilation flow rate (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 filtering time constant has a sufficiently long value to encompass several respiratory cycles, for example, approximately 10 seconds. The leak flow rate Ql can be estimated as the product of the leak conductivity and the pressure Pm.

[0492] Respiratory flow rate estimation

[0493] In one form of this technology, the respiratory flow 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 patient's air respiratory flow rate Qr by subtracting the ventilation flow rate Qv and the leakage flow rate Ql from the total flow rate Qt.

[0494] Healing Engine Module

[0495] In one form of this technology, the treatment engine module 4320 receives one or more of the pressure Pm in the patient interface 3000 or 3800 and the breathing flow rate Qr of the air to the patient as input, and provides one or more treatment parameters as output.

[0496] In one form of this technique, the treatment parameter is the treatment pressure Pt.

[0497] In one form of this technique, the treatment parameters are one or more of the following: pressure variation amplitude, baseline pressure, and target ventilation.

[0498] In various forms, the treatment engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow restriction determination 4324, apnea / insufficiency determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and treatment parameter determination 4329.

[0499] Phase determination

[0500] In one form of this technology, the RPT device has an uncertain phase of 4000.

[0501] In one form 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 patient's current respiratory cycle 1000 as output.

[0502] 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 dual-valued phase output Φ with either inspiratory or expiratory values, for example, values ​​represented as 0 and 0.5 revolutions, respectively, at the start of spontaneous inspiration and expiration. The “triggering” and “cycling” RPT device 4000 effectively performs discrete phase determination because the trigger point and cycling point are the moments when the phase changes from expiration to inspiration and from inspiration to expiration, respectively. In one implementation of dual-valued phase determination, the phase output Φ is determined to have a discrete value of 0 (thus “triggering” the RPT device 4000) when the respiratory flow rate Qr has a value exceeding a positive threshold, and the phase output Φ is determined to have a discrete value of 0.5 revolutions (thus “cycling” the RPT device 4000) when the respiratory flow rate Qr has a value more negative than a negative threshold. The inspiratory time Ti and expiratory time Te can be estimated as typical values ​​over multiple respiratory cycles of the time taken for the phase Φ to be equal to 0 (representing inspiration) and 0.5 (representing expiration), respectively.

[0503] Another implementation of discrete phase determination provides a three-valued phase output Φ with one of the values ​​of inhalation, mid-inspiratory pause, and exhalation.

[0504] In other forms known as continuous phase determination, the phase output Φ is a continuous variable, such as varying from 0 to 1 revolution or 0 to 2 radians. The RPT device 4000 performing continuous phase determination can be triggered and cycled when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one implementation of continuous phase determination, fuzzy logic analysis of the respiratory flow rate Qr is used to determine the continuous value of the phase Φ. The continuous value of the phase determined in this implementation is often referred to as the "fuzzy phase." In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr:

[0505] 1. If the respiratory flow rate is zero and increases rapidly, the phase is 0 revolutions.

[0506] 2. If the respiratory flow rate is a large positive value and stable, the phase is 0.25 revolutions.

[0507] 3. If the respiratory flow rate is zero and decreases rapidly, the phase is 0.5 revolutions.

[0508] 4. If the respiratory flow rate is a large negative value and stable, the phase is 0.75 revolutions.

[0509] 5. If the respiratory flow rate is zero and stable, and the absolute value of the 5-second low-pass filter for the respiratory flow rate is large, then the phase is 0.9 revolutions.

[0510] 6. If the respiratory flow rate is positive and the phase is exhalation, then the phase is 0 revolutions.

[0511] 7. If the respiratory flow rate is negative and the phase is inspiration, then the phase is 0.5 revolutions.

[0512] 8. If the absolute value of the 5-second low-pass filter for respiratory flow rate is large, the phase increases at a steady rate equal to the patient's respiratory rate, and is low-pass filtered with a time constant of 20 seconds.

[0513] The output of each rule can be represented as a vector, with phase representing the result of the rule and amplitude representing the degree of ambiguity of the rule being true. The degree of ambiguity for respiratory flow rates such as "large" and "stable" is determined using appropriate membership functions. The results of the rules are represented as vectors and then combined using a function such as centroid. In such combinations, rules can be weighted equally or differently.

[0514] In another implementation of continuous phase determination, the phase Φ is first estimated discretely from the respiratory flow rate Qr as described above, as are the inspiratory time Ti and expiratory time Te. The continuous phase Φ at any given time can be determined as half of the inspiratory time Ti that has elapsed since the previous trigger, or 0.5 revolutions plus half of the expiratory time Te that has elapsed since the previous cycle (based on the most recent time).

[0515] Waveform determination

[0516] In one form of this technology, the treatment parameter determination algorithm 4329 provides an approximately constant treatment pressure throughout the patient's respiratory cycle.

[0517] In other forms of this technology, the treatment control module 4330 controls the pressure generator 4140 to provide a treatment pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle, based on the waveform template Π(Φ).

[0518] In one form of this technology, waveform determination algorithm 4322 provides a waveform template Π(Φ), whose value in the range of [0, 1] over the phase value Φ domain provided by phase determination algorithm 4321 will be used by treatment parameter determination algorithm 4329.

[0519] In a form suitable for discrete or continuous phase values, the waveform template Π(Φ) is a square wave template with a value of 1 for phase values ​​up to and including 0.5 revolutions, and a value of 0 for phase values ​​greater than 0.5 revolutions. In a form suitable for continuous phase values, the waveform template Π(Φ) includes two smooth curve portions: for phase values ​​up to 0.5 revolutions, the smooth curve (e.g., raised cosine) rises from 0 to 1, while for phase values ​​greater than 0.5 revolutions, the smooth curve (e.g., exponential) decays from 1 to 0. In a form suitable for continuous phase values, the waveform template Π(Φ) is based on a square wave, but with a "rise time" where the phase value smoothly rises from 0 to 1 until less than 0.5 revolutions, and a "fall time" where the phase value smoothly falls from 1 to 0 after 0.5 revolutions, where the "fall time" is less than 0.5 revolutions.

[0520] 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 relative to the phase value Φ. In other forms, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) "in operation" using a predetermined function form that may be parameterized by one or more parameters (e.g., the time constant of the exponential curvature portion). The parameters of the function form can be predetermined or depend on the current state of the patient 1000.

[0521] In some forms of this technique suitable for discrete two-valued phases of inhalation (Φ = 0 rpm) or exhalation (Φ = 0.5 rpm), the waveform determination algorithm 4322 calculates the waveform template Π "in operation" as a function of the discrete phase Φ and the time t measured from the most recent trigger moment. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ, t) in both parts (inhalation and exhalation) as follows:

[0522]

[0523] Among them Π i (t) and Π e (t) represents the inhalation and exhalation portions of the waveform template Π(Φ, t). In one such form, the inhalation portion Π of the waveform template... i (t) is a smooth rise from 0 to 1 parameterized by the rise time, and the expiratory portion of the waveform template is Π e (t) is a smooth descent from 1 to 0 parameterized by the descent time.

[0524] Ventilation volume determination

[0525] In one form of this technology, the ventilation determination algorithm 4323 receives the respiratory flow rate Qr as input and determines a metric indicating the current patient ventilation volume Vent.

[0526] In some implementations, the ventilation determination algorithm 4323 determines a measure of ventilation Vent, which is an estimate of the actual patient ventilation. One such implementation takes half the absolute value of the respiratory flow rate Qr, which is optionally filtered by a low-pass filter such as a second-order Bessel low-pass filter with an angular frequency of 0.11 Hz.

[0527] In other implementations, the ventilation determination algorithm 4323 determines a measure of ventilation Vent that is substantially proportional to the actual patient ventilation. One such implementation estimates the peak respiratory flow rate Qpeak over the inspiratory portion of the cycle. If the flow waveform shape does not change significantly (here, the shapes of two breaths are considered similar when the flow waveforms of the breaths normalized in time and amplitude are similar), this process and many other processes involving sampling the respiratory flow rate Qr produce a measure that is substantially proportional to the ventilation. Some simple examples include the median of the positive respiratory flow rate, the median of the absolute value of the respiratory flow rate, and the standard deviation of the flow rate. Any linear combination of any order statistic of the absolute value of the respiratory flow rate using positive coefficients, and even some linear combinations of any order statistic of the absolute value of the respiratory flow rate using both positive and negative coefficients, are approximately proportional to the ventilation. Another example is the average value of the respiratory flow rate in the middle K proportion (by time) of the inspiratory portion, where 0<K<1. If the flow shape is constant, there are any large number of measurements that are exactly proportional to the ventilation.

[0528] Determination of inspiratory flow limitation

[0529] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the degree of inspiratory flow limitation.

[0530] In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow rate signal Qr as an input, and provides a measure of the degree to which the inspiratory portion of the breath exhibits inspiratory flow limitation as an output.

[0531] In one form of the present technology, the inspiratory portion of each breath is identified by a zero-crossing detector. An interpolator interpolates a plurality of evenly spaced points (e.g., 65 points) representing time points along the inspiratory flow rate-time curve of each breath. The curve described by the points is then scaled by a scalar to have a uniform length (duration / cycle) and a uniform area to eliminate the effects of changing respiratory rate and depth. The scaled breath is then compared in a comparator with a pre-stored template representing a normal unobstructed breath, similar to Figure 6AThe diagram shows the inspiratory portion of the breath. At any point during the inspiratory period from this template, breaths deviating beyond a specified threshold (typically 1 scaling unit) are rejected, such as those caused by coughing, sighing, swallowing, and hiccups as determined by the test element. For non-rejected data, the central controller 4230 calculates a moving average of the first such scaling point of the preceding few inspiratory events. For the second such point, this is repeated on the same inspiratory event, and so on. Thus, for example, sixty-five scaling data points are generated by the central controller 4230 and represent the moving average of the preceding few inspiratory events (e.g., three events). The moving average of the continuously updated values ​​of the sixty-five points is referred to below as the “scaling flow rate,” denoted as Qs(t). Alternatively, a single inspiratory event can be used instead of a moving average.

[0532] Based on the scaled flow rate, two shape factors related to determining partial blockage can be calculated.

[0533] The shape factor 1 is the ratio of the average of the intermediate (e.g., thirty-two) scaled flow points to the average of the total (e.g., sixty-five) scaled flow points. When this ratio is greater than one, breathing is normal. When the ratio is one or less, breathing is obstructed. When the ratio is 1 or less, breathing is considered obstructed. A ratio of approximately 1.17 is used as the threshold between partially obstructed and unobstructed breathing, and is equal to the degree of obstruction that allows for adequate oxygenation in a typical patient.

[0534] The shape factor 2 is calculated as the RMS deviation from a unit scaled flow rate at intermediate (e.g., 32) points. An RMS deviation of approximately 0.2 units is considered normal. Zero RMS deviation is considered fully flow-limited breathing. The closer the RMS deviation is to zero, the more airflow is restricted during breathing.

[0535] Shape factors 1 and 2 can be used interchangeably or in combination. In other forms of this technique, the number of sampling points, breaths, and intermediate points can differ from those described above. Furthermore, the threshold can differ from the threshold described.

[0536] Determination of apnea and insufficiency

[0537] In one form of this technology, the central controller 4230 executes an apnea / hypoventricular dysfunction determination algorithm 4325 to determine the presence of apnea and / or hypoventricular dysfunction.

[0538] In one form, the apnea / insufficiency determination algorithm 4325 receives a respiratory flow signal Qr as input and provides a flag indicating that apnea or insufficiency has been detected as output.

[0539] In one form, apnea is considered detected when a function of respiratory flow rate Qr falls below a flow rate threshold within a predetermined time period. This function can determine peak flow rate, relatively short-term average flow rate, or an intermediate flow rate between relatively short-term average and peak flow rates, such as RMS flow rate. The flow rate threshold can be a relatively long-term measure of flow rate.

[0540] In one form, insufficiency is considered detected when a function of respiratory flow rate Qr falls below a second flow rate threshold within a predetermined time period. This function can be determined by peak flow, a relatively short-term average flow rate, or an intermediate flow rate between the relatively short-term average and peak flow rates, such as the RMS flow rate. The second flow rate threshold can be a relatively long-term measure of flow rate. The second flow rate threshold is greater than the flow rate threshold used to detect apnea.

[0541] Snoring confirmed

[0542] In one form of this technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the degree of snoring.

[0543] In one form, the snoring determination algorithm 4326 receives a respiratory flow rate signal Qr as input and provides a measure of the degree of snoring presence as output.

[0544] The snoring determination algorithm 4326 may include the step of determining the intensity of the flow rate signal in the range of 30 to 300 Hz. Furthermore, the snoring determination algorithm 4326 may include the step of filtering the respiratory flow rate signal Qr to reduce background noise (e.g., airflow noise from the blower in the system).

[0545] Airway patency confirmed

[0546] In one form of this technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining the degree of airway patency.

[0547] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as input and determines the signal power in a frequency range of approximately 0.75 Hz to approximately 3 Hz. A peak in this frequency range indicates airway patency. The absence of a peak is considered an indication of airway closure.

[0548] In one implementation, the frequency range for finding the peak is the frequency of a small forced oscillation in the therapeutic pressure Pt. In another implementation, the forced oscillation frequency is 2 Hz, and the amplitude is approximately 1 cmH2O.

[0549] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as input and determines whether a cardiac signal is present. The absence of a cardiac signal is considered an indication of a closed airway.

[0550] Determination of target ventilation

[0551] In one form of this technology, the central controller 4230 takes the measured value of the current ventilation volume Vent as input and executes one or more target ventilation volume determination algorithms 4328 to determine a target value Vtgt of the ventilation volume measurement.

[0552] In some forms of this technology, there is no target ventilation determination algorithm 4328, and the target value Vtgt is predetermined, for example, by hard coding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0553] In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from the value Vtyp, which indicates the patient's typical recent ventilation.

[0554] In some forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated as a high percentage, but less than, of the typical recent ventilation volume Vtyp. This high percentage can be in the range of (80%, 100%), (85%, 95%), or (87%, 92%).

[0555] In other forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated as an integer multiple that is slightly larger than the typical recent ventilation volume Vtyp.

[0556] A typical recent ventilation volume (Vtyp) is the value at which the distribution of current ventilation volume (Vent) measurements tends to cluster over several moments on some predetermined time scales; that is, it is a measure of the central tendency of the current ventilation volume measurements in recent history. In one implementation of the target ventilation volume determination algorithm 4328, the recent history is on the order of minutes, but should in any case be longer than the Cheyne-Stokes rise-fall cycle timescale. The target ventilation volume determination algorithm 4328 can use any of a variety of well-known measures of central tendency to determine the typical recent ventilation volume (Vtyp) from the current ventilation volume (Vent) measurement. One such measure is the output of a low-pass filter on the current ventilation volume (Vent) measurement, with a time constant of 100 seconds.

[0557] Determination of treatment parameters

[0558] In some forms of this technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 to determine one or more treatment parameters using values ​​returned by one or more other algorithms in the treatment engine module 4320.

[0559] In one form of this technology, the treatment parameter is the instantaneous treatment pressure Pt. In one implementation of this form, the treatment parameter determination algorithm 4329 uses the following equation to determine the treatment pressure Pt:

[0560] Pt=AΠ(Φ,t)+P0 (1)

[0561] in:

[0562] A is the amplitude.

[0563] ·Π(Φ, t) is the waveform template value (in the range of 0 to 1) at the current value of phase Φ and time t, and

[0564] P0 is the base pressure.

[0565] If the waveform determination algorithm 4322 provides a waveform template Π(Φ, t) as a lookup table for the value Π indexed by the phase Φ, then the treatment parameter determination algorithm 4329 applies equation (1) by locating the nearest lookup table entry to the current value Φ of the phase returned by the phase determination algorithm 4321, or by interpolating between two entries that span the current value Φ of the phase.

[0566] The values ​​of amplitude A and baseline pressure P0 can be determined by treatment parameter algorithm 4329 in the following manner according to the selected respiratory pressure treatment mode.

[0567] Treatment control module

[0568] According to one aspect of the present technology, the treatment control module 4330 receives treatment parameters from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 as input, and controls the pressure generator 4140 to deliver an airflow according to the treatment parameters.

[0569] In one form of this technology, the treatment parameter is the treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 to deliver an airflow, the airflow having an interface pressure Pm at the patient interface 3000 or 3800 equal to the treatment pressure Pt.

[0570] Fault detection

[0571] In one form of this technology, the central controller 4230 executes one or more methods 4340 for detecting fault conditions. The fault conditions detected by the one or more methods 4340 may include at least one of the following:

[0572] • Power failure (no power or insufficient power)

[0573] Sensor fault detection

[0574] The presence of the component could not be detected.

[0575] • Operating parameters are outside the recommended range (e.g., pressure, flow rate, temperature, PaO2).

[0576] • The test alarm failed to generate a detectable alarm signal.

[0577] When a fault condition is detected, the corresponding algorithm 4340 notifies the existence of the fault by one or more of the following signals:

[0578] • Activate auditory, visual, and / or dynamic (e.g., vibration) alarms

[0579] Send messages to external devices

[0580] • Event Log

[0581] air circuit

[0582] According to one aspect of the present technology, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow between two components, such as the RPT device 4000 and the patient interface 3000 or 3800.

[0583] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be referred to as an air delivery tube. In some cases, it may have separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0584] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may be connected to a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0585] In some forms, cables carrying electricity or data can also be incorporated into the air circuit 4170, for example, by wrapping the cable around the outer surface of the air circuit 4170. Such wrapped cables can be held in place, for example, by one or more layers of textile material.

[0586] Supplemental gas delivery

[0587] In one form of this technology, supplemental gas (e.g., oxygen) 4180 is delivered to one or more points in the pneumatic path, such as upstream of pneumatic block 4020, to air circuit 4170, and / or to patient interface 3000 or 3800.

[0588] Humidifier

[0589] Humidifier Overview

[0590] In one form of this technology, a humidifier 5000 is provided (e.g., as...). Figure 5 (As shown in A) to change the absolute humidity of the air or gas delivered to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0591] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some forms, such as Figure 5 A and Figure 5 As shown in Figure B, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to house the humidifier reservoir 5110 and includes a heating element 5240.

[0592] Humidifier components

[0593] Water storage tank

[0594] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a volume of liquid to be evaporated (e.g., water) to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building water supply system.

[0595] According to one aspect, the water reservoir 5110 is configured to increase the humidity of the airflow from the RPT device 4000 as the airflow passes through it. In one form, the water reservoir 5110 may be configured to cause the airflow to travel along a tortuous path through the water reservoir 5110 while in contact with a certain volume of water in the water reservoir.

[0596] According to one form, the storage 5110 can, for example, be in such a form as Figure 5 A and Figure 5 Removed from humidifier 5000 in the lateral direction shown in B.

[0597] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any orifice and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent pneumatic pressure loss through leakage and / or flow resistance.

[0598] conductive part

[0599] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity can be achieved using materials with appropriate geometries and lower thermal conductivity.

[0600] Humidifier reservoir base

[0601] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 configured to receive a humidifier reservoir 5110 (e.g., Figure 5 (As shown in B). In some arrangements, the humidifier reservoir base 5130 may include locking components, such as a locking lever 5135 configured to retain the reservoir 5110 in the humidifier reservoir base 5130.

[0602] Water level indicator

[0603] Humidifier reservoir 5110 may include, for example Figure 5 A to Figure 5 The water level indicator 5150 shown in Figure B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as a patient 1000 or a caregiver, regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0604] Humidifier transducer

[0605] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210, replacing or additional to the transducer 4270 described above. The humidifier transducer 5210 may include, for example... Figure 5 One or more of the following sensors are shown in Figure C: air pressure sensor 5212, air velocity sensor 5214, temperature sensor 5216, or humidity sensor 5218. The humidifier transducer 5210 can generate one or more output signals that can be transmitted to a controller such as a central controller 4230 and / or a humidifier controller 5250. In some forms, the humidifier transducer can be located external to the humidifier 5000 (e.g., in the air circuit 4170) while simultaneously transmitting output signals to the controller.

[0606] pressure transducer

[0607] In addition to, or in place of, the pressure sensor 4272 provided in the RPT device 4000, one or more pressure transducers 5212 may be provided to the humidifier 5000.

[0608] Flow transducer

[0609] In addition to, or in place of, the flow rate sensor 4274 provided in the RPT device 4000, one or more flow rate transducers 5214 may be provided in the humidifier 5000.

[0610] Temperature transducer

[0611] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures of airflow downstream of the heating element 5240 and / or the humidifier outlet 5004. In some forms, the humidifier 5000 may also include a temperature sensor 5216 to detect the temperature of ambient air.

[0612] Humidity transducer

[0613] In one embodiment, the humidifier 5000 may include one or more humidity sensors 5218 to detect the humidity of a gas, such as ambient air. The humidity sensors 5218 may be positioned in some manner toward the humidifier outlet 5004 to measure the humidity of the gas supplied from the humidifier 5000. The humidity sensors may be absolute humidity sensors or relative humidity sensors.

[0614] heating element

[0615] In some cases, heating element 5240 may be provided to humidifier 5000 to provide heat input to a volume of water in humidifier reservoir 5110 and / or to one or more air streams. Heating element 5240 may include heating components, such as resistive electric heating rails. A suitable example of heating element 5240 is a layered heating element, such as the layered heating element described in PCT patent application publication number WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0616] In some configurations, the heating element 5240 may be disposed in the humidifier base 5006, wherein heat can be supplied primarily to the humidifier reservoir 5110 via conduction, such as Figure 5 As shown in B.

[0617] Humidifier controller

[0618] According to one arrangement of the present technology, the humidifier 5000 may include, for example: Figure 5 The humidifier controller 5250 shown in Figure C. In one embodiment, the humidifier controller 5250 may be part of the central controller 4230. In another embodiment, the humidifier controller 5250 may be a separate controller that can communicate with the central controller 4230.

[0619] In one embodiment, the humidifier controller 5250 may receive measurements of, for example, airflow, water in the reservoir 5110, and / or characteristics of the humidifier 5000 (such as temperature, humidity, pressure, and / or flow rate) as inputs. The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.

[0620] like Figure 5 As shown in C, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heating air circuit controller 5254 configured to control the temperature of the heating air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240.

[0621] Screening, diagnosis and monitoring system

[0622] Overview

[0623] At least some forms of this technology allow for the use of sensors integrated into a patient interface to screen, diagnose, and / or monitor sleep health. The sensors can be positioned within the positioning and stabilization structure of the patient interface, such as... Figure 4 A and Figure 4 B's positioning and stabilizing structure 6300, and / or located in the inflatable chamber of the patient interface.

[0624] For example, as described above, a sensor-enabled positioning and stabilization structure in the form of a headband (such as positioning and stabilization structure 6300) can be worn by the patient as a stand-alone headband before the start of treatment and record sensor measurements during sleep. Sensor measurements can be used to precisely monitor sleep stages and sleep positions, track vital signs and other physiological indicators, and detect apnea and / or hypopnea events. Clinicians can use the sleep and physiological data to diagnose sleep disorders and recommend appropriate treatment. Furthermore, the same parameters can be monitored by sensors during treatment and compared with parameters before the start of treatment (or at an earlier stage of treatment) to allow patients and clinicians to assess the effectiveness of the treatment.

[0625] As described above, physiological and sleep data can be recorded by one or more sensors on the patient interface and transmitted to an external computing device (such as the patient's smartphone) and / or to a monitoring server operated or accessible by a clinician or other healthcare provider.

[0626] In some forms of this technology, a pulse oximeter integrated into the positioning and stabilization structure 6300 can be used to determine blood oxygen saturation levels and heart rate during patient interface 6000 wear, and this data can be transmitted to an external computing device, such as a smartphone, other mobile computing device, or the patient's on-lap or desktop computing system. Time-series data can be combined to provide patients with feedback on their health status and recommendations for follow-up (e.g., provided by a clinician), such as based on the determination of AHI as described above, which can be combined with other sensor measurements to determine when and how frequently apnea events occur, and the optimal treatment plan for the patient.

[0627] Other sensors that can be incorporated into a screening, diagnostic, and / or monitoring system that includes a sensor-enabled patient interface include, but are not limited to: an EEG sensor for detecting sleep stages; EMG and EOG sensors for determining REM sleep stage events; a microphone for detecting snoring or other sounds indicating sleep disturbances; and humidity, temperature, pressure, and / or CO2 sensors, each of which is located inside the air chamber 6200 of the patient interface.

[0628] The following describes some example applications of the sensor-enabled patient interface.

[0629] Polysomnography

[0630] Polysomnography (PSG) is a monitoring process that typically involves a variety of different sensors and associated devices, and can be challenging to install even for experts. A typical PSG system includes a headbox that receives and records signals from the following sensors: EOG electrodes; EEG electrodes; ECG electrodes; submental EMG electrodes; a snoring sensor; a respiratory effort sensor (PRF sensor) on a chest strap; a respiratory effort sensor (PRF sensor) on an abdominal strap; a naso-oral cannula with an oral thermistor; a photoplethysmography (POP) device; and a body position sensor. The electrical signal is referred to as the grounded electrode (ISOG) located in the center of the forehead.

[0631] A sensor-enabled patient interface, such as patient interface 6000, can replace some or all of the functions of an existing PSG system because, as described above, some or all of the sensors used in a PSG system can be housed in the positioning and stabilization structure (e.g., 6300) and / or the inflation chamber (e.g., 6200). For example, EOG, EEG, ECG, and EMG electrodes, a microphone (used as a snoring sensor), a PPG sensor, and an accelerometer and / or gyroscope (used as a body posture sensor) can all be housed in the upper textile portion 6310 and / or the lower textile portions 6308, 6320 of the positioning and stabilization structure 6300. A grounding electrode can also be provided (e.g., in the lower textile portion 6308, for placement behind the patient's ear, as described above).

[0632] In at least some instances, PSG is made simpler by integrating the sensor with the patient interface 6000, as patients can simply wear the patient interface 6000 in the manner they are receiving treatment, without requiring or requiring only minimal additional configuration (e.g., no need to manually place the various electrodes for the EEG / EMG / EOG sensor).

[0633] Non-intrusive monitoring system

[0634] In one example, one or more accelerometers and / or one or more gyroscopes and / or one or more other motion sensors may be disposed in the positioning and stabilization structure 6300. The motion sensors are configured to generate one or more signals representing the patient's body movements, from which signals representing the patient's respiratory movements can be obtained.

[0635] Breathing polyscopy

[0636] Polyphonic respiratory gauging (RPG) is a simplified form of PSG without electrical signals (EOG, EEG, EMG), snoring, or body posture sensors. Typically, RPG includes at least chest motion signals from a respiratory-sensored plethysmography (motion sensor) on a chest strap, nasal pressure signals sensed via a nasal cannula, and oxygen saturation signals from a pulse oximeter (e.g., a pulse oximeter). These three RPG signals or channels are received by an RPG headbox.

[0637] A sensor-enabled patient interface, such as the Patient Interface 6000, can replace some or all of the functions of an existing RPG system. For example, accelerometer and / or gyroscope measurements from sensors mounted in the headband 6300 can be used as a substitute for chest motion signals. Nasal pressure signals can be measured by pressure sensors mounted in the inflation chamber, for example, mounted on the inner surface of the inflation chamber so as to be close to the patient's nostrils during use. Oxygen saturation signals can be measured by PPG sensors mounted in the headband 6300, for example... Figure 9C As shown at point 6355 in the diagram. Alternative chest movement signals, nasal pressure signals, and oxygen saturation signals can be received by the onboard processor 6350 of the patient interface 6000, and / or can be transmitted to an external computing device for analysis in the same manner as conventional RPG signals.

[0638] In some configurations, the nasal pressure signal is a satisfactory substitute for the nasal flow rate signal generated by a flow rate transducer connected in series with a sealed nasal mask, since the nasal pressure signal is similar in shape to the nasal flow rate signal. If the patient's mouth remains closed, i.e., there is no oral leakage, the nasal flow rate is equal to the respiratory flow rate.

[0639] Portable oxygen concentrator (POC)

[0640] Portable oxygen concentrators can utilize pressure swing adsorption (PSA). PSA can involve using one or more compressors to increase the gas pressure within a canister containing gas-separating adsorbent particles arranged in a “sieve bed.” As the pressure increases, some molecules in the gas may be adsorbed onto the gas-separating adsorbent. Removing a portion of the gas from the canister under pressurized conditions allows the separation of unadsorbed molecules from the adsorbed molecules. The gas-separating adsorbent can be regenerated by reducing the pressure, which reverses the adsorption of molecules from the adsorbent. Further details regarding oxygen concentrators can be found, for example, in U.S. Patent Application Publication No. 2009-0065007, entitled “Oxygen Concentrator Apparatus and Method,” published March 12, 2009, which is incorporated herein by reference.

[0641] Ambient air typically comprises approximately 78% nitrogen and 21% oxygen, with the remainder consisting of argon, carbon dioxide, water vapor, and other trace gases. For example, if a gas mixture (such as air) is passed under pressure through a canister containing a gas-separating adsorbent bed that adsorbs nitrogen more strongly than oxygen, some or all of the nitrogen will remain in the bed, and the gas exiting the canister will be oxygen-rich. When the bed reaches its limit of nitrogen adsorption capacity, it can be regenerated by reducing the pressure, thereby releasing the adsorbed nitrogen. This prepares the canisters for another cycle of producing oxygen-enriched air. In a dual-canister system, alternating canisters allow one canister to separate oxygen while the other is purified (resulting in continuous separation of oxygen and nitrogen). In this way, oxygen-enriched air can be accumulated in, for example, storage containers or other pressurized containers or conduits connected to the canisters for a variety of uses, including providing supplemental oxygen to patients.

[0642] Breathing therapy mode

[0643] Various respiratory therapy modes can be achieved through the disclosed respiratory therapy system.

[0644] CPAP treatment

[0645] In some implementations of respiratory pressure therapy, the central controller 4230 sets the treatment pressure Pt according to the treatment pressure equation (1) as part of the treatment parameter determination algorithm 4329. In one such implementation, the amplitude A is also zero, so the treatment pressure Pt (which represents the target value achieved by the interface pressure Pm at the current moment) is equal to the baseline pressure P0 throughout the respiratory cycle. This implementation is typically grouped under the heading of CPAP therapy. In this implementation, the treatment engine module 4320 does not need to determine the phase Φ or the waveform template Π(Φ).

[0646] In CPAP therapy, the basal pressure P0 can be a constant value, either hard-coded or manually input into the RPT device 4000. Alternatively, the central controller 4230 can repeatedly calculate the basal pressure P0 as a function of an indicator or measure of sleep-disordered breathing, such as flow restriction, apnea, hypopnea, patency, and snoring, returned by a corresponding algorithm in the therapy engine module 4320. This option is sometimes referred to as APAP therapy.

[0647] Figure 4 E is a flowchart illustrating method 4500 executed by central controller 4230, which continuously calculates base pressure P0 when pressure support A is equal to zero, as part of the APAP treatment implementation of treatment parameter determination algorithm 4329.

[0648] Method 4500 begins at step 4520, where the central controller 4230 compares a measurement of the presence of apnea / insufficiency with a first threshold and determines whether the measurement has exceeded the first threshold for a predetermined time period, thereby indicating that apnea / insufficiency is occurring. If so, method 4500 proceeds to step 4540; otherwise, method 4500 proceeds to step 4530. In step 4540, the central controller 4230 compares a measurement of airway patency with a second threshold. If the airway patency measurement exceeds the second threshold, indicating that the airway is patent, the detected apnea / insufficiency is considered central, and method 4500 proceeds to step 4560; otherwise, the apnea / insufficiency is considered obstructive, and method 4500 proceeds to step 4550.

[0649] In step 4530, the central controller 4230 compares the measured value of the flow restriction with a third threshold. If the measured value of the flow restriction exceeds the third threshold, indicating that the inspiratory flow is restricted, then method 4500 proceeds to step 4550; otherwise, method 4500 proceeds to step 4560.

[0650] In step 4550, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment ΔP, provided that the resulting treatment pressure Pt does not exceed the maximum treatment pressure Pmax. In one implementation, the predetermined pressure increment ΔP and the maximum treatment pressure Pmax are 1 cmH2O and 25 cmH2O, respectively. In other implementations, the pressure increment ΔP can be as low as 0.1 cmH2O and as high as 3 cmH2O, or as low as 0.5 cmH2O and as high as 2 cmH2O. In other implementations, the maximum treatment pressure Pmax can be as low as 15 cmH2O and as high as 35 cmH2O, or as low as 20 cmH2O and as high as 30 cmH2O. Method 4500 then returns to step 4520.

[0651] In step 4560, the central controller 4230 reduces the base pressure P0 by a reduction amount, provided that the reduced base pressure P0 does not fall below the minimum therapeutic pressure Pmin. Method 4500 then returns to step 4520. In one implementation, the reduction is proportional to the value of P0-Pmin, such that the decrease of P0 to the minimum therapeutic pressure Pmin is exponential in the absence of any detected event. In one implementation, the proportionality constant is set such that the time constant τ for the exponential decrease of P0 is 60 minutes, and the minimum therapeutic pressure Pmin is 4 cmH2O. In other implementations, the time constant τ can be as low as 1 minute and as high as 300 minutes, or as low as 5 minutes and as high as 180 minutes. In other implementations, the minimum therapeutic pressure Pmin can be as low as 0 cmH2O and as high as 8 cmH2O, or as low as 2 cmH2O and as high as 6 cmH2O. Alternatively, the reduction of P0 can be predetermined, so that the decrease of P0 to the minimum therapeutic pressure Pmin is linear in the absence of any detected event.

[0652] Bilevel therapy

[0653] In other implementations of this form of the technique, the value of amplitude A in equation (1) can be positive. This implementation is called bilevel therapy because when determining the treatment pressure Pt using equation (1) with a positive amplitude A, the treatment parameter determination algorithm 4329 oscillates the treatment pressure Pt between two values ​​or levels in sync with the patient's spontaneous respiratory effort. That is, based on the typical waveform template Π(Φ, t) described above, the treatment parameter determination algorithm 4329 increases the treatment pressure Pt to P0+A (referred to as IPAP) at the start of or during expiration or during inspiration, and decreases the treatment pressure Pt to the baseline pressure P0 (referred to as EPAP) at the start of or during expiration.

[0654] In some forms of bilevel therapy, IPAP is a therapeutic pressure serving the same purpose as the therapeutic pressure in CPAP therapy, and EPAP is IPAP minus amplitude A, which has a “small” value (a few cmH2O) sometimes referred to as expiratory pressure release (EPR). This form is sometimes referred to as CPAP therapy using EPR, and it is generally considered more comfortable than direct CPAP therapy. In CPAP therapy using EPR, both IPAP and EPAP can be constant values ​​hard-coded or manually entered into the RPT device 4000. Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate IPAP and / or EPAP during CPAP with EPR. In this alternative, the treatment parameter determination algorithm 4329 repeatedly calculates EPAP and / or IPAP as a function of an indicator or measure of sleep-disordered breathing returned by the corresponding algorithm in the treatment engine module 4320, in a manner similar to the calculation of the basal pressure P0 in APAP therapy described above.

[0655] In other forms of bilevel therapy, the amplitude A is large enough that the RPT device 4000 can perform some or all of the patient's breathing work. In this form, known as pressure support ventilation, the amplitude A is referred to as pressure support or oscillation. In pressure support ventilation, IPAP is the baseline pressure P0 plus pressure support A, and EPAP is the baseline pressure P0.

[0656] In some forms of pressure support ventilation therapy known as fixed pressure support ventilation, pressure support A is fixed at a predetermined value, such as 10 cmH2O. The predetermined pressure support value is set by the RPT device 4000 and can be set, for example, by hard coding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0657] In other forms of pressure support ventilation therapy, widely known as servo ventilation, the treatment parameter determination algorithm 4329 takes some currently measured or estimated parameters of the respiratory cycle (e.g., the current measurement of ventilation, Vent) and the target value of that respiratory parameter (e.g., the target value of ventilation, Vtgt) as input, and repeatedly adjusts the parameters of equation (1) to make the current measurement of the respiratory parameter close to the target value. In a form of servo ventilation known as adaptive servo ventilation (ASV), which has been used to treat CSR, the respiratory parameter is ventilation, and the target ventilation value Vtgt is calculated by the target ventilation determination algorithm 4328 based on a typical recent ventilation Vtyp, as described above.

[0658] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control method to repeatedly calculate the pressure support A so that the current measurements of the respiratory parameters are close to the target values. One such control method is proportional-integral (PI) control. In one implementation of PI control, suitable for an ASV mode where the target tidal volume Vtgt is set slightly less than the typical recent tidal volume Vtyp, the pressure support A is repeatedly calculated as follows:

[0659] A=G∫(Vent-Vtgt)dt (2)

[0660] Where G is the gain controlled by PI. A larger value of gain G can result in positive feedback in the treatment engine module 4320. A smaller value of gain G can allow some residual untreated CSR or central sleep apnea. In some embodiments, gain G is fixed at a predetermined value, such as -0.4 cmH2O / (L / min) / sec. Alternatively, gain G can be varied between treatment sessions, starting small and increasing between sessions until a value is reached that substantially eliminates CSR. In such embodiments, conventional methods for retrospectively analyzing parameters of treatment sessions to assess the severity of CSR during treatment can be employed. In other embodiments, gain G can be varied based on the difference between the current measurement of ventilation (Vent) and the target ventilation (Vtgt).

[0661] Other servo ventilation control methods that can be applied by algorithm 4329, which can be determined by treatment parameters, include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0662] The pressure support value A calculated via equation (2) can be limited to a range defined as [Amin, Amax]. In this implementation, the pressure support A is at the minimum pressure support Amin by default until the measured value of the current ventilation volume Vent drops below the target ventilation volume Vtgt, at which point A begins to increase and only drops back to Amin when Vent exceeds Vtgt again.

[0663] The pressure support limits Amin and Amax are settings for the RPT device 4000, for example, by hard coding or by manual input via input device 4220 during the configuration of the RPT device 4000.

[0664] In pressure support ventilation therapy, EPAP is the baseline pressure P0. Similar to the baseline pressure P0 in CPAP therapy, EPAP can be a constant value specified or determined during titration. Such a constant EPAP can be set, for example, through hard coding during RPT device 4000 configuration or through manual input via input device 4220. This alternative is sometimes referred to as fixed EPAP pressure support ventilation therapy. EPAP titration for a given patient can be performed by the clinician during titration using a PSG to prevent obstructive apnea, thereby maintaining an open airway for pressure support ventilation therapy in a manner similar to the titration of baseline pressure P0 in constant CPAP therapy.

[0665] Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate the basal pressure P0 during pressure support ventilation therapy. In such an implementation, the treatment parameter determination algorithm 4329 repeatedly calculates EPAP as a function of an index or measure of sleep-disordered breathing returned by the corresponding algorithm in the treatment engine module 4320, such as flow restriction, apnea, hypopnea, patency, and snoring, or one or more of these. Because the continuous calculation of EPAP is similar to the manual adjustment of EPAP by a clinician during EPAP titration, this process is sometimes referred to as automatic EPAP titration, and the treatment mode is referred to as automatic titration EPAP pressure support ventilation therapy or automatic EPAP pressure support ventilation therapy.

[0666] High-flow therapy

[0667] In other forms of respiratory therapy, the pressure of the airflow is not controlled as in respiratory pressure therapy. Instead, a central controller 4230 controls a pressure generator 4140 to deliver an airflow, the device flow rate Qd of which is controlled as a therapeutic flow rate or target flow rate Qtgt, which is typically positive throughout the patient's respiratory cycle. Such forms are often grouped under the heading of flow therapy. In flow therapy, the therapeutic flow rate Qtgt can be a constant value either hard-coded or manually entered into the RPT device 4000. If the therapeutic flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, the therapy is typically referred to as high-flow therapy (HFT). Alternatively, the therapeutic flow rate can be a curve Qtgt(t) that varies with the respiratory cycle.

[0668] Glossary

[0669] For the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0670] General Rules

[0671] Air: In some forms of this technology, air may refer to atmospheric air, while in other forms of this technology, air may refer to certain other combinations of breathable gases, such as oxygen-enriched air.

[0672] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0673] For example, regarding the environment of humidifiers humidity This could be the humidity of the air immediately surrounding the humidifier, such as the humidity in the patient's sleeping room. This type of ambient humidity can differ from the humidity outside the patient's sleeping room.

[0674] In another instance, environmental stress can be stress that is directly around the body or external to the body.

[0675] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, rather than noise generated by, for example, the RPT device or emitted from the mask or patient interface. Ambient noise may be generated by sources outside the room.

[0676] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure can be automatically adjusted between minimum and maximum, such as from breath to breath, depending on the presence or absence of SDB event indicators.

[0677] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between the patient's different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of an indication of partial upper airway obstruction.

[0678] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, i.e., a quantity that has only magnitude. In other cases, the reference to flow rate will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. "Flow rate" is sometimes simply abbreviated as "flow" or "airflow".

[0679] In the context of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the flow rate of air leaving the vent to allow the expulsion of exhaled gases. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air inhaled into the patient's respiratory system.

[0680] Flow therapy: Breathing therapy, which involves delivering a flow of air to the airway inlet at a controlled flow rate known as the therapeutic flow rate, which is generally positive throughout the patient’s respiratory cycle.

[0681] Humidifier: The term humidifier will be considered to refer to a humidification device that is constructed and arranged or configured with a physical structure that provides a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the patient’s medical respiratory condition.

[0682] Leakage: The word "leakage" is considered to refer to undesirable airflow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel bend leading to the surrounding environment.

[0683] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0684] Noise, radiated (acoustic): Radiated noise in this document refers to noise delivered to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0685] Noise, ventilation (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening (such as the ventilation port of the patient interface).

[0686] Oxygen-enriched air: Air with an oxygen concentration greater than that of the atmosphere (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen-enriched air” is sometimes simply referred to as “oxygen”.

[0687] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0688] Patient: A person, regardless of whether they have a respiratory illness.

[0689] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 g-f / cm³ 2 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 = 1 millibar to 0.001 atmospheres (atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0690] The pressure in the patient interface is represented by the symbol Pm, while the treatment pressure is represented by the symbol Pt. The treatment pressure represents the target value that the interface pressure Pm needs to achieve at the current moment.

[0691] Respiratory pressure therapy: Applying an air supply to the airway inlet at a therapeutic pressure that is normally positive relative to the atmosphere.

[0692] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0693] Material

[0694] Silicone or silicone elastomer: Synthetic rubber. In this specification, reference to silicone refers to liquid silicone (LSR) or molding silicone (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise stated to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45, as measured using ASTM D2240.

[0695] Polycarbonate: a transparent thermoplastic polymer of bisphenol A carbonate.

[0696] Mechanical properties

[0697] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0698] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0699] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured on a standardized sample size).

[0700] "Soft" materials can include silicone or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0701] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0702] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistance in different directions. The reciprocal of stiffness is flexibility.

[0703] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0704] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0705] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0706] Respiratory circulation

[0707] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0708] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0709] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0710] Effort (breathing): The work done by a spontaneously breathing person in trying to breathe.

[0711] The expiratory phase of the respiratory cycle: the time period from the start of expiratory flow rate to the start of inspiratory flow rate.

[0712] Flow restriction: Flow restriction is considered a working state of breathing in which an increase in the patient's effort does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0713] Types of flow-limited inhalation waveforms:

[0714] (i) Flattening: First rises, then a relatively flat section, then falls.

[0715] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0716] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0717] (iv) Inverted chair shape: has a relatively flat section followed by a single local peak located at the trailing edge.

[0718] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow, not a cessation of flow. In one form, insufficient breathing can be considered to occur when the flow rate decreases below a threshold rate over a period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to a reduction in respiratory effort. In one form in adults, any of the following can be considered insufficient breathing:

[0719] (i) The patient's breathing decreases by 30% for at least 10 seconds plus a related 4% desaturation; or

[0720] (ii) The patient’s breathing decreases (but less than 50%) for at least 10 seconds, accompanied by at least 3% of related desaturation or arousal.

[0721] Hyperventilation: The flow rate increases to above normal levels.

[0722] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow rate to the start of expiratory flow rate is considered the inspiratory portion of the respiratory cycle.

[0723] Airway openness: The degree to which the airway is open or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0724] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.

[0725] Peak flow rate (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0726] Respiratory flow, patient air flow, and respiratory air flow (Qr): These synonymous terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0727] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) equals the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined as equal to any one of these volumes. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0728] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0729] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0730] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.

[0731] Typical recent ventilation: The ventilation value that tends to be concentrated in recent times over a predetermined time scale, i.e., the measurement of the central tendency of recent ventilation values.

[0732] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a flow-limiting state, where the flow rate increases only slightly, or may even decrease as the pressure differential in the upper airway increases (Starling resistor behavior).

[0733] Ventilation: A measurement of the rate at which gases are exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0734] ventilation

[0735] Adaptive Servo Ventilator (ASV): A type of servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be derived from certain characteristics of the patient, such as the patient's respiratory characteristics.

[0736] Standby rate: A ventilator parameter used to determine the minimum respiratory rate (usually measured in breaths per minute) that the ventilator can deliver to the patient if it is not triggered by spontaneous breathing effort.

[0737] Cycle: Termination of the inspiratory phase of the respiratory cycle. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator is considered to have stopped delivering breaths at the end of the inspiratory portion of the respiratory cycle.

[0738] Positive Expiratory Airway Pressure (EPAP): A baseline pressure to which changes in intraventilatory pressure are added to produce the desired interface pressure that the ventilator attempts to achieve at a given time.

[0739] End-expiratory pressure (EEP): The desired interface pressure that the ventilator attempts to reach at the end of the expiratory phase of breathing. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., Π(Φ) = 0 when Φ = 1, then EEP equals EPAP.

[0740] Positive inspiratory airway pressure (IPAP): The maximum expected interface pressure that the ventilator attempts to achieve during the inspiratory phase of breathing.

[0741] Pressure support: This refers to the increase in pressure during inspiratory breathing that exceeds the increase in pressure during expiratory breathing. It is typically the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP – EPAP). In some cases, pressure support refers to the difference that the ventilator is designed to achieve, rather than the difference it actually achieves.

[0742] Servo ventilator: A ventilator that measures a patient’s ventilation, has a target ventilation, and adjusts the pressure support level to bring the patient’s ventilation close to the target ventilation.

[0743] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0744] Oscillation: A term equivalent to pressure support.

[0745] Triggering: A patient is said to be triggered 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 patient who is breathing spontaneously. Triggering usually occurs at or near the start of the breathing portion of a respiratory cycle with the patient's effort.

[0746] Anatomical structure

[0747] Facial Anatomy

[0748] Alar: The outer wall or "wing" of each nostril (plural: alar)

[0749] Alar tip: the outermost point on the ala of the nose.

[0750] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.

[0751] Auricle: The entire visible external part of the ear.

[0752] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0753] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0754] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0755] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (the two lines intersect at the lower point of the nasal septum).

[0756] Frankfurt plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0757] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0758] External nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0759] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilages. It curves around the front of the nostrils. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0760] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril (nare) is nasal nasal (naris). The nostrils are separated by the nasal septum.

[0761] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0762] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0763] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0764] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0765] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0766] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0767] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0768] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0769] Sagittal plane: A vertical plane running from front to back. The midsagittal plane is the sagittal plane that divides the body into the right and left halves.

[0770] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0771] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0772] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.

[0773] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0774] Mandibular alveolar point: The point of maximum concavity located on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue anterior mental point.

[0775] Anatomical structure of the skull

[0776] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0777] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0778] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0779] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0780] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0781] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval-shaped foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0782] The eye socket is the bony cavity in the skull that houses the eyeball.

[0783] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0784] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0785] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

[0786] Anatomical structure of the respiratory system

[0787] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0788] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0789] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0790] Nasal chambers: The nasal chambers (or nasal fossae) are large, air-filled spaces located in the middle of the face above and behind the nose. The nasal chambers are divided into two parts by vertical wings called the nasal septum. On the sides of the nasal chambers are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal cavity is the nasal part, while the back connects to the nasopharynx via the internal nasal openings.

[0791] Pharynx: 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 (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0792] Patient Interface

[0793] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0794] Bend: A bend is an example of a structure that directs the axis of an airflow traveling through it by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. A bend can have an approximately circular cross-section. In another form, a bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removed from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0795] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more points of connection with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0796] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headband may include an assembly of one or more support bars, straps, and reinforcements configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, elastic materials, such as laminated composites of foam and fabric.

[0797] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0798] Pneumatic chamber: The pneumatic chamber of a mask will be considered to refer to a portion of the patient interface having walls that at least partially enclose a volume of space, which, in use, contains air pressurized therein to above atmospheric pressure. A housing may form part of the wall of the pneumatic chamber of the mask.

[0799] Seal: can be the noun form indicating structure ("seal") or the verb form indicating effect ("seal"). Two elements can be constructed and / or arranged to be "sealed" or to achieve a "seal" between them, without the need for a separate "sealing" element itself.

[0800] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0801] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0802] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0803] Rotary shaft: (noun) a sub-component of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assemblies of the component preferably comprise a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotary shaft.

[0804] Lacing (noun): A structure used to resist tension.

[0805] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to effectively flush out exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0806] Structural shape

[0807] Products according to this technology may include one or more three-dimensional mechanical structures, such as face mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the outer surface) and separate surfaces that do not contact the face (e.g., the underside or inner surface). In yet another example, a structure may include a first surface and a second surface.

[0808] To facilitate the description of the shape of the three-dimensional structure and surface, we first consider the cross-section through the surface of the structure at point P. See [link to documentation]. Figures 3B to 3F This shows an example of a cross section at point p on the surface, and the resulting planar curve. Figures 3B to 3F The outward normal vector at point p is also shown. The outward normal vector at point P points away from the surface. In some examples, the surface is depicted from the viewpoint of an imaginary little person standing upright on the surface.

[0809] One-dimensional curvature

[0810] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle that just touches the curve at p).

[0811] Positive curvature: If the curve at point P turns outward toward the normal, then the curvature at that point will be positive (if you imagine little figures leaving point p, they must walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to a relatively small positive curvature). Such curves are often referred to as concave.

[0812] Zero curvature: If the curve at point P is a straight line, then the curvature will be zero (if you imagine a little person leaving point P, they can walk horizontally without going up or down). See also Figure 3D .

[0813] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little people leaving point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are usually called convex.

[0814] Curvature of a two-dimensional surface

[0815] A description of the shape at a given point on a two-dimensional surface according to the present invention may include multiple normal sections. These sections may cut through the surface in a plane including an outward normal (“normal plane”), and each section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a quantity, for example, a relatively small quantity. Figures 3B to 3F A planar curve can be an instance of multiple cross sections at a specific point.

[0816] Principal curvature and principal direction: The direction of the normal plane to which the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, and the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross section in the principal direction. The principal curvature at point p is the curvature in the principal direction.

[0817] A region of a surface: a connected set of points on the surface. The set of points in a region can have similar characteristics, such as curvature or sign.

[0818] Saddle-shaped region: a region in which the principal curvature has opposite signs at each point, i.e., one sign is positive and the other sign is negative (which may be going up or down depending on the direction the imagined individual is turning).

[0819] Dome region: The region where the principal curvature has the same sign at each point, such as both being positive ("concave dome") or both being negative ("convex dome").

[0820] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0821] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0822] Edge of a surface: the boundary or limit of a surface or region.

[0823] Path: In some forms of this technique, "path" will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, "path" can be described as a route or distance, including, for example, a set of points on a surface. (The path of an imaginary person is the place where they walk on the surface, and is similar to a garden path).

[0824] Path length: In some forms of this technique, "path length" will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length for an imaginary person would be the distance they must walk along the path on the surface.)

[0825] Straight-line distance: Straight-line distance is the distance between two points on a surface, but without considering the surface itself. On a planar region, there will exist paths on the surface with the same path length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same path length as the straight-line distance between the two points. (For an imaginary individual, straight-line distance will correspond to the distance as a "straight line".)

[0826] Space curves

[0827] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. Imagine a person walking along a space curve on one strand of a DNA helix. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the curve. Torque is a measure of how the curve deviates from the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0828] 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. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If a fictional person were flying along a curve and crashed from her vehicle at a specific point, the direction of the tangent vector would be the direction she would have been traveling.

[0829] Unit normal vector: This is the vector that changes as an imaginary person moves along the curve. The unit vector pointing in the direction of the change of the tangent vector is called the principal normal vector. It is perpendicular to the tangent vector.

[0830] A double-normal unit vector is a vector that is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see example...). Figure 3P ) determines, or alternatively, is determined by the left-hand rule ( Figure 3O )Sure.

[0831] Oscillating plane: A plane containing both a unit tangent vector and a unit principal normal vector. See also Figure 3O and Figure 3P .

[0832] Twist of a space curve: The twist of a space curve at a point is the magnitude of the rate of change of the unit vector of the binormal at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in the osculating plane has zero twist. A space curve deviating relatively small from the osculating plane will have a relatively small amount of twist (e.g., a gently sloping spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large amount of twist (e.g., a sharply sloping spiral path). Reference Figure 3S Since T2 > T1, Figure 3S The amplitude of the twist near the top coil of the spiral is greater than Figure 3S The amplitude of the twist of the bottom coil of the spiral.

[0833] refer to Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand binormal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral is shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0834] Equivalently, and referring to the left-hand rule (see...) Figure 3O A space curve that turns in the direction of the left-hand double normal can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0835] hole

[0836] Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., membranes) can be described as having one-dimensional pores. See, for example, [example missing]. Figure 3I The structure shown has a one-dimensional hole in the surface bounded by a planar curve.

[0837] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L padding and through Figure 3M and Figure 3N An example cross-section is shown, illustrating the inner surface defining a two-dimensional orifice. In yet another example, a conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the conduit's inner surface. See also Figure 3K The two-dimensional hole through the structure shown is defined by the surface shown.

[0838] Other notes

[0839] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of these patent documents or patent disclosures by any person in the form they appear in the patent office documents or records, but otherwise reserves all copyright rights.

[0840] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and also within the scope of this technique, but are subject to any explicitly excluded boundaries within the range. Where a range includes one or both of the limit values, this technique also includes ranges that exclude any one or both of those included limit values.

[0841] Furthermore, where one or more values ​​described herein are implemented as part of this technique, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used to the extent permitted or required by the practical implementation of the technique for any appropriate valid digits.

[0842] Furthermore, as used herein, “about,” “substantially,” “approximately,” or any similar terms mean + / - 5% to 10% of the stated values.

[0843] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0844] When a particular material is determined to be used for constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0845] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” used herein and in the appended claims include their plural equivalents.

[0846] All publications mentioned herein are incorporated herein in their entirety by reference to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure by virtue of a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0847] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0848] The headings used in the detailed description are for convenience of the reader only and should not be used to limit the subjects that can be found throughout the invention or the claims. These headings should not be used to interpret or limit the scope of the claims.

[0849] Although the present technology has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may imply specific details not required by the practical art. For example, although the terms "first" and "second" may be used, unless otherwise stated, they are not intended to indicate any order but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.

[0850] Therefore, it should be understood that various modifications can be made to the illustrative examples and other arrangements can be designed without departing from the spirit and scope of this technology.

Claims

1. A patient interface for delivering an airflow to a patient to treat sleep apnea, the patient interface comprising: An air chamber, which at least partially forms an internal space capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the air chamber including an air chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure from a flow generator for patient breathing, for the treatment of sleep apnea. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening such that an airflow under the therapeutic pressure is delivered to at least one inlet of the patient's nostril, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use; A positioning and stabilizing structure, the positioning and stabilizing structure being used to provide forces that hold the sealing structure in a therapeutically effective position on the patient's head; One or more electronic components for monitoring and / or diagnosing the patient, the one or more electronic components being disposed in or on one or more of the inflation chamber, the sealing structure, and the positioning and stabilizing structure; as well as A power system for converting energy generated during use of the patient interface into electrical energy for powering the one or more electronic components, the power system including at least one energy harvesting device comprising a turbine generator. The energy generated during the use of the patient interface includes the mechanical energy generated by the airflow from the flow generator passing through the turbine generator while the airflow is being supplied to the interior space of the inflation chamber. The turbine generator is located downstream of the flow generator and upstream of the internal space.

2. The patient interface of claim 1, wherein the power system provides DC voltage to one or more of the electronic components.

3. The patient interface according to claim 1 or claim 2, wherein the power system is configured to charge an energy storage device, wherein one or more of the electronic components are connected to the energy storage device.

4. The patient interface according to any one of claims 1 to 3, wherein the turbine generator is located within the connection port of the patient interface.

5. The patient interface according to claim 4, wherein the turbine generator is located at the air inlet of the patient interface.

6. The patient interface according to any one of claims 1 to 3, wherein the turbine generator is located in the inlet port of the inflation chamber, or adjacent to the inlet port of the inflation chamber and located within the inflation chamber.

7. The patient interface according to any one of claims 1 to 3, wherein the at least one energy harvesting device comprises two or more energy harvesting devices.

8. The patient interface of claim 7 further includes a vent configured to discharge air into the surrounding environment.

9. The patient interface according to any one of claims 1 to 3, wherein the turbine generator includes a rotor, the rotor including a plurality of turbine blades and a plurality of magnets disposed around the periphery of the rotor.

10. The patient interface of claim 9, wherein the magnet is positioned near the base of the turbine blade.

11. The patient interface of claim 10, wherein the turbine generator includes a sealed stator assembly housing a plurality of coils, the sealed stator assembly being disposed around the rotor.

12. The patient interface according to any one of claims 1 to 3, wherein the power system comprises at least one piezoelectric film.

13. The patient interface of claim 12, wherein at least one of the piezoelectric films is attached to, or disposed within, the inflation chamber and / or the sealing structure and / or the positioning and stabilizing structure.

14. The patient interface according to any one of claims 1 to 3, wherein the power system comprises at least one thermoelectric generator (TEG) module.

15. The patient interface of claim 14, wherein at least one TEG module is disposed within the positioning and stabilization structure.

16. The patient interface of claim 15, wherein at least one TEG module is arranged to contact the patient's skin.

17. The patient interface of claim 14, wherein at least one TEG module is arranged such that a first surface of the TEG module is exposed to the interior of the inflation chamber, and a second surface opposite to the first surface is exposed to the surrounding environment.

18. The patient interface of claim 3, wherein the power system includes an external charging circuit configured to charge the energy storage device.

19. The patient interface of claim 18, wherein the external charging circuit is a component of a respiratory pressure therapy device configured to deliver the airflow to the inflation chamber.

20. The patient interface of claim 19, wherein the external charging circuit is connectable to the energy storage device via one or more cables incorporated into or above the air circuit connecting the respiratory pressure therapy device and the inflation chamber.

21. The patient interface according to any one of claims 1 to 3, wherein the one or more electronic components comprise one or more sensors and / or one or more actuators.

22. The patient interface of claim 21, wherein at least one sensor and / or at least one actuator is partially exposed to the surrounding environment at the outer surface of the positioning and stabilizing structure; and / or partially exposed at the patient contact surface of the positioning and stabilizing structure to contact the patient's skin in use.

23. The patient interface of claim 21, wherein at least one sensor and / or at least one actuator is at least partially embedded between the outer layer of the positioning and stabilizing structure and the patient contact layer.

24. The patient interface of claim 21, wherein at least one sensor and / or at least one actuator comprises a circuit formed at least partially by one or more conductive wires and / or one or more conductive ink lines.

25. The patient interface of claim 21, wherein the one or more electronic components include a wireless communication interface for transmitting data from the one or more sensors to one or more external computing devices, and / or for receiving data from the one or more external computing devices at the one or more actuators.

26. The patient interface of claim 21, wherein the one or more sensors and / or one or more actuators comprise one or more of the following: an accelerometer; a gyroscope; a humidity sensor; a temperature sensor; a microphone; a camera; a pulse oximeter; an EEG sensor; an EMG sensor; an EOG sensor; a touch sensor; a vibration device; and an audio output device.

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