Application to guide mask fitting

Abstract

To provide an application guiding mask fitting.SOLUTION: A respiratory pressure therapy system for providing a patient with continuous positive air pressure via a patient interface includes a flow generator generating breathable gas supply for delivery to the patient via the patient interface, a sensor, a display, and a computing device. The computing device includes: receiving sensor data that is based on a measured physical property of the supply of breathable gas; controlling the flow generator on the basis of the received sensor data to adjust a property of the supply of breathable gas; receiving input indicating that assistance is needed by using the patient interface; receiving an image of the patient by using the patient interface; analyzing the received image; and displaying onto the display instructions for positioning the patient interface on the basis of the analysis.SELECTED DRAWING: Figure 6A

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims priority to Singapore Patent Application No. 10201911248T (filing date: November 27, 2019). The entire content of this document is incorporated herein by reference for all purposes.

Background Art

[0002] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and improving respiratory - related disorders. This technology also relates to medical devices or apparatuses and their use, and more particularly, to detecting the mispositioning of an inappropriate patient interface associated with a medical device or apparatus and / or guiding the positioning and / or adjustment of the patient interface to a correct fitting position. 2.2 Description of related technologies 2.2.1 The human respiratory system and its disorders

[0003] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0004] These airways include a series of bronchial tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main function of the lungs is gas exchange, which involves taking in oxygen from the inhaled air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become terminal bronchioles. The bronchi constitute the conducting airways and are not involved in gas exchange. When the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See Non - Patent Document 1 below.

[0005] There is a range of respiratory disorders. Specific disorders may be characterized by specific events (e.g., apnea, hypopnea, and hyperventilation).

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events such as closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, and the normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of such a disorder, apneas in affected patients typically last from 30 to 120 seconds, and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular disease and brain damage. This syndrome is a common disorder, particularly common in middle-aged overweight men, but patients are asymptomatic. See Patent Document 1 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory control, in which alternating cycles of increasing and decreasing ventilation, known as the CSR cycle, occur periodically. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is accompanied by repeated sleep awakenings, which can cause severe insomnia, increased sympathetic nerve activity, and increased afterload. See Patent Document 2 (Berthon-Jones).

[0009] Respiratory insufficiency is a general term for respiratory disorders and refers to the inability of the lungs to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the patient's needs. Respiratory insufficiency may include some or all of the following disorders.

[0010] Patients with respiratory insufficiency (a type of respiratory insufficiency) may experience abnormal shortness of breath during exercise.

[0011] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during waking hours in a state where the cause of hypoventilation is otherwise not clearly defined. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. This includes an increase in resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing a number of disorders and diseases that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Some NMD patients are characterized by progressive muscle impairment, which ultimately leads to inability to walk, wheelchair confinement, dysphagia, reduced respiratory muscle strength, and ultimately death due to respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive. (i) Characteristics of rapidly progressive disorders: Muscle impairment that worsens over several months and leads to death within a few years (such as amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in the teens, etc.). (ii) Degenerative or slowly progressive disorders: Muscle impairment that worsens over several years but only slightly shortens life expectancy (such as limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Respiratory insufficiency symptoms in NMD are listed below. Increased general debility, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, headache upon waking, and difficulty with concentration and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that cause ineffectiveness of the connection between the respiratory muscles and the thorax. These disorders are mainly characterized by restrictive disorders and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may develop severe respiratory failure. The symptoms of respiratory failure are listed below. Dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, headache upon waking up, fatigue, decreased quality of sleep, and loss of appetite.

[0015] To treat or improve such diseases, a certain range of treatments are being used. Furthermore, in other aspects, even healthy individuals can advantageously utilize preventive treatment for respiratory disorders. However, there are multiple drawbacks in these. 2.2.2 Treatment

[0016] A variety of respiratory treatments (e.g., continuous positive airway pressure (CPAP) treatment, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are being used for the treatment of one or more of the above-mentioned respiratory disorders. 2.2.2.1 Respiratory pressure treatment

[0017] Respiratory pressure treatment is the application of supplying air to the airway inlet at a controlled target pressure that is normally positive pressure with respect to the atmosphere over the entire respiratory cycle of the patient (different from negative pressure treatment such as a tank ventilator or a cuirass).

[0018] Continuous positive airway pressure (CPAP) treatment is being used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue to move forward or backward against the posterior oropharyngeal wall, continuous positive airway pressure functions as an air pressure sprint, thereby preventing the closure of the upper airway. Since the treatment of OSA by CPAP treatment can be spontaneous, if such a patient notices one or more of the following about the device used for treatment delivery, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0019] Non-invasive ventilation (NIV) provides ventilation assistance to a patient through the upper airway and performs part or all of the respiratory function to assist the patient's breathing and / or maintain an appropriate oxygen level in the body. The ventilation assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] Invasive ventilation (IV) provides ventilation assistance to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved. 2.2.2.2 Flow treatment

[0021] In all respiratory therapies, the delivery of a defined therapeutic pressure is not necessarily intended. In some respiratory therapies, the delivery of a defined tidal volume is intended by delivering an inspiratory flow profile (perhaps superposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (seal broken), and respiratory therapy by means of a regulated gas or high-concentration gas flow can only be used as an aid to the patient's spontaneous breathing. In one example, high-flow therapy (HFT) is the provision of a continuous, heated, humidified airflow at a "therapy flow" that is maintained substantially constant throughout the respiratory cycle through a non-sealed or open patient interface. The therapy flow is nominally set to exceed the patient's peak inspiratory flow. HFT is used for the treatment of OSA, CSR, respiratory insufficiency, COPD, and other respiratory disorders. As one mechanism of action, providing high-flow air to the airway inlet improves ventilation efficiency because it enables the flushing or washout of CO2 exhaled from the patient's anatomic dead space. For this reason, HFT is sometimes referred to as dead space therapy (DST). Other benefits include improved warmth and humidification (perhaps due to the benefits of secretions control) and the possibility of a gentle increase in airway pressure. As an alternative to a constant flow, the therapy flow can follow a profile that varies over the respiratory cycle.

[0022] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. A physician may prescribe that a continuous flow of oxygen-enriched gas be delivered to the patient's airway at a specified oxygen concentration (oxygen fraction in ambient air from 21% to 100%) and at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM). 2.2.2.3 Supplemental Oxygen

[0023] In the case of a particular patient, a combination of oxygen therapy and respiratory pressure therapy or HFT can be obtained by adding supplemental oxygen to a pressurized air flow. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting treatment is referred to as HFT with supplemental oxygen. 2.2.3 Respiratory therapy system

[0024] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating a disease.

[0025] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen breathing source, and data management.

[0026] Another form of treatment system is a mandibular repositioning device. 2.2.3.1 Patient interface

[0027] The patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an air flow to an airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the treatment applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby facilitating gas delivery at a pressure of sufficient dispersion with the ambient pressure for treatment execution (e.g., at a positive pressure of about 10 cmH2O relative to the ambient pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. In the case of flow therapy such as nasal HFT, the patient interface is configured to deliver air to the nostrils (and clearly avoid a complete seal). An example of such a patient interface is a nasal cannula.

[0028] Certain other mask systems may be functionally inappropriate in this field. For example, in the case of masks for purely decorative purposes, it may not be possible to maintain appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and to not maintain internal air at a pressure higher than the surroundings.

[0029] Certain masks may be clinically unfavorable in this technology (for example, when the mask blocks airflow through the nose and only allows airflow through the mouth).

[0030] In certain masks, it may be uncomfortable or impractical in this technology when the patient has to insert part of the mask structure into the mouth and create and maintain a seal through the lips.

[0031] Certain masks may be impractical for use during sleep (for example, when sleeping on one's side in bed with the head on a pillow).

[0032] There are multiple challenges in the design of a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory therapy period.

[0033] Due to these problems, in the case of some masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more reasons such as being overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic administration mask can withstand their original uses, but in the case of such masks, they may be unacceptably uncomfortable for wearing over a long period (e.g., several hours). Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0034] CPAP treatment is extremely effective in the treatment of certain respiratory disorders when the patient agrees to the treatment. If the mask is uncomfortable or difficult to use, the patient may not agree to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's compliance.

[0035] In the case of masks for other uses (e.g., pilots), they may not be suitable for use in the treatment of sleep apnea, so masks designed for use in the treatment of sleep apnea may be suitable for other uses.

[0036] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field. 2.2.3.1.1 Seal-forming structure

[0037] The patient interface may include a seal-forming structure. Since the patient interface comes 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.

[0038] The patient interface may be partially characterized according to the design intent of where the seal-forming structure engages the face during use. In one form of the patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces may be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0039] A seal-forming structure that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variabilities, and sensitive regions of the patient's face. For example, the seal of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0040] A particular seal-forming structure can be designed for mass production to fit one design for a wide range of different face shapes and sizes and be comfortable and effective. To form a seal, it may be necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of any mismatch between them.

[0041] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when force is applied to the patient interface with the seal-forming structure engaged against the patient's face. This seal-forming structure may include an air or fluid-filled cushion or may include a shaped or formed surface of an elastic seal element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap may occur between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0042] Another type of seal-forming structure uses a thin flap seal disposed around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previously described type of seal-forming portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal or leakage may occur from the mask. Further, if the shape of the seal-forming structure does not conform to the shape of the patient, creases or buckling may occur during use, causing leakage.

[0043] Another type of seal-forming structure may include a friction fit element inserted into the nostrils, for example, although there are patients who find this uncomfortable.

[0044] Another form of seal-forming structure may use an adhesive portion to achieve a seal. There are also patients who always find it inconvenient to attach or remove the adhesive portion to their face.

[0045] Regarding the technology of a range of patient interface seal-forming structures, there are disclosures in the following patent applications assigned to ResMed Limited: Patent Document 3; Patent Document 4; Patent Document 5.

[0046] One form of nasal pillow is found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of Patent Document 6 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0047] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask and MIRAGE LIBERTY™ Full Face Mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: Patent Document 7 (describing in particular the appearance of ResMed Limited's SWIFT® nasal pillow); Patent Document 8 (describing in particular the appearance of ResMed Limited's SWIFT® LT nasal pillow); Patent Documents 9 and 10 (describing in particular the appearance of ResMed Limited's MIRAGE LIBERTY™ Full Face Mask); Patent Document 11 (describing in particular the appearance of ResMed Limited's SWIFT® FX nasal pillow). 2.2.3.1.2 Positioning and Stabilization

[0048] The seal-forming structure of the patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that impede sealing. Therefore, various techniques are used to position the seal-forming structure and maintain the seal against the appropriate part of the face.

[0049] In one technique, an adhesive part is used. See, for example, Patent Document 12. However, when an adhesive part is used, there may be discomfort.

[0050] In another technique, one or more straps and / or stabilization harnesses are used. In the case of a number of such harnesses, one or more of the following apply: poor fit, bulky, uncomfortable and difficult to handle. 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0051] The Respiratory Pressure Therapy (RPT) device can be used individually for the delivery of one or more of the above - mentioned therapies or as part of a system, for example, by operating the device to generate an air delivery flow to the airway interface. The air flow can be pressure - controlled (for respiratory pressure therapy) or flow - controlled (for flow therapies such as HFT). Therefore, the RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0052] Air pressure generators are known in a wide range of applications (e.g., industrial - scale ventilation systems). However, air pressure generators for medical use have specific requirements that cannot be satisfied by more general air pressure generators (e.g., reliability requirements, size requirements, and weight requirements for medical devices). In addition, even devices designed for medical treatment may be defective in relation to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0053] An example of a special requirement for a particular RPT device is acoustic noise.

[0054] Table of the noise output levels of conventional RPT devices (measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample).

[0055] [Table 1]

[0056] As one known RPT device used for the treatment of sleep disordered breathing, there is the S9 sleep therapy system (manufacturer: ResMed Limited). Another example of an RPT device is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar™ series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive non-dependent ventilation for patients over a certain range for the treatment of multiple diseases (non-limiting examples include NMD, OHS, and COPD).

[0057] The ResMed Elisee™ 150 ventilator and the ResMed VSIII™ ventilator can provide assistance for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of multiple diseases. With these ventilators, volume ventilation mode and pressure ventilation mode using single or double limb circuits can be obtained. The RPT device typically includes a pressure generator (e.g., an electric blower or a compressed gas reservoir) and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway with positive pressure. The outlet of the RPT device is connected to the patient interface as described above via an air circuit.

[0058] The device designers can be presented with countless options. Since the design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Furthermore, the comfort and effectiveness of a particular aspect can also be greatly affected by minor changes in one or more parameters. 2.2.3.3 Air Circuit

[0059] The air circuit is a conduit or tube constructed and arranged such that, during use, an air flow moves between two components of the respiratory therapy system (e.g., the RPT device and the patient interface). In some cases, there can be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation. 2.2.3.4 Humidifier

[0060] When the delivery of the air flow is carried out without humidification, it may lead to the drying of the airway. When a humidifier is used together with an RPT device and a patient interface, humidified gas is generated, so the drying of the nasal mucosa is minimized and the comfort of the patient airway is increased. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort more than in the case of cold air. Therefore, humidifiers often have the ability not only to heat the air flow but also to humidify the air flow.

[0061] A certain range of artificial humidifying devices and systems are known, but they do not meet the special requirements of medical humidifiers.

[0062] Medical humidifiers are typically used to increase the humidity and / or temperature of the air flow relative to the ambient air when the patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed next to the pillow may be small. A medical humidifier may be configured to only humidify and / or heat the air flow delivered to the patient and not humidify and / or heat the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air taken into the patient's body by breathing, but in the case of these systems, since they also humidify and / or heat the entire room, it can be uncomfortable for the occupants. Furthermore, in the case of medical humidifiers, there may be more stringent safety constraints than for industrial humidifiers.

[0063] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, and some may be difficult or inconvenient for patients to use. 2.2.3.5 Oxygen breathing source

[0064] Experts in this field have long recognized that when patients with respiratory failure exercise, they can obtain long-term benefits such as delaying disease progression, improving quality of life, and extending the patient's lifespan. However, stationary exercises such as treadmills and stationary bicycles are too strenuous for these patients. Therefore, the need for mobility has been long recognized. Until recently, this mobility has been facilitated by using small compressed oxygen tanks or cylinders mounted on carts. The drawbacks of these tanks are that the amount of oxygen they can store is limited and they are heavy, weighing approximately 50 pounds when mounted.

[0065] Oxygen concentrators have been used for approximately 50 years for the supply of oxygen for respiratory therapy. In the case of conventional oxygen concentrators, due to their bulky and heavy nature, it is difficult and impractical to perform normal walking activities while wearing an oxygen concentrator. Recently, manufacturers of large stationary oxygen concentrators have started developing portable oxygen concentrators (POCs). The advantage of POCs is that theoretically, they can supply oxygen endlessly. To make these devices small for mobility, the various systems required for oxygen-enriched gas generation are highly integrated. To minimize weight, size, and power consumption, POCs need to make the use of the generated oxygen as efficient as possible. This can be achieved by delivering oxygen as a series of pulses or "boluses", each bolus being set at a timing that coincides with the start of inspiration. This treatment mode is known as pulsed or demand (oxygen) delivery (POD) and is more suitable for stationary oxygen concentrators than conventional continuous flow delivery. 2.2.3.6 Data Management

[0066] There may be a case where data is obtained to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following one or more "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient must use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, a provider of the RPT device (e.g., a healthcare provider) may obtain data describing the patient's treatment with the RPT device manually, calculate the usage rate over a given period, and compare this to the compliance rule. If the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0067] In a patient's treatment, there may be other ways to benefit from communication of treatment data to a third party or an external system.

[0068] In the case of existing processes for communicating and managing such data, one or more of high cost, time-consuming, and error-prone may occur. 2.2.3.7 Mandibular Repositioning

[0069] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other providers that holds the mandible (lower jawbone) in a forward position during sleep. The MRD is a removable device that is inserted into the mouth before the patient goes to sleep and removed after sleep. Therefore, the MRD is not designed for continuous wear applications. The MRD may be custom-made or manufactured in a standard form and includes an occlusal impression portion designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension to the pharyngeal wall, reducing airway collapse and reducing palatal vibration.

[0070] In certain examples, the mandibular advancement device may include an upper splint intended to engage or fit over the teeth on the maxilla or maxillary bone and a lower splint intended to engage or fit over the teeth on the maxilla or mandibular bone. The upper splint and the lower splint are laterally connected to each other via a pair of connecting rods. This set of connecting rods is symmetrically fixed on the upper splint and the lower splint.

[0071] In such a design, the length of the connecting rod is selected such that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to vary the level of protrusion of the mandible. The dentist can determine the level of protrusion according to the mandible, and as a result, the length of the connecting rod is determined.

[0072] There are also MRDs configured to push the mandible forward relative to the maxilla, as well as those designed to hold the mandible in a forward position, like other MADs such as the ResMed Narval CC (trademark) MRD. This device also reduces or minimizes dental side effects and side effects of the temporomandibular joint (TMJ) between the temple and the mandible. Therefore, this device is configured to minimize or avoid any movement of one or more of the teeth. 2.2.3.8 Ventilation Technology

[0073] Some forms of treatment systems may include a ventilation portion for expelling the exhaled carbon dioxide. This ventilation portion may enable gas flow from the internal space (e.g., the plenum chamber) of the patient interface to the outside (e.g., the surroundings) of the patient interface.

[0074] This ventilation portion may include an orifice, and when using a mask, gas can flow through the orifice. In the case of a number of such ventilation portions, the sound is noisy. In other cases, it may be blocked during use, resulting in insufficient extrusion. In the case of some ventilation portions, for example, due to sound or airflow concentration, it may interfere with the sleep of patient 1000 and co-sleeper 1100.

[0075] ResMed Limited has developed a number of improved mask ventilation technologies. See the following: Patent Document 13; Patent Document 14; Patent Document 15; Patent Document 16; Patent Document 17.

[0076] Table of noises of conventional masks (ISO17510-2:2007, at 1 m under a pressure of 10 cmH2O)

[0077] [Table 2]

[0078] (*Measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample)

[0079] List the sound pressure values of various subjects as follows:

[0080] [Table 3]

[0081] 2.2.4 Screening, Diagnostic Systems and Monitoring Systems

[0082] A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary disorders and typically requires expert clinical staff for system application in many cases. In a PSG, typically 15 to 20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG)). For PSG of sleep disordered breathing, patients needed to be observed in a specialized hospital for two nights. That is, the first night was for pure diagnosis and the second night was necessary for titration of treatment parameters by a clinician. Therefore, PSG is costly and has low convenience. Screening / diagnosis / monitoring of sleep disordered breathing is particularly unsuitable at home.

[0083] Generally, screening and diagnosis are to identify a disease based on the signs and symptoms of the disease. Usually, screening gives a true / false result indicating whether the patient's SDB warrants further investigation, while diagnosis often provides clinically actionable information. Unlike screening and diagnosis, which tend to be one-time procedures, monitoring the course of a disease can be continued indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0084] A clinical expert can appropriately perform patient screening, diagnosis or monitoring based on visual observation of PSG signals. However, there are situations where there is no clinical expert or payment to a clinical expert cannot be made. Opinions of clinical experts may differ regarding a patient's disease. Furthermore, a certain clinical expert may apply different criteria depending on the time.

Prior Art Documents

Patent Documents

[0085]

Patent Document 1

Patent Document 2

[0086] [Non-Patent Document 1] "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

Summary of the Invention

[0087] 3 Brief Description of the Technology

[0088] The present technology relates to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory disorders, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0089] The first aspect of the present technology relates to a device used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory disorders.

[0090] Another aspect of the present technology relates to a method used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory disorders.

[0091] One aspect of a particular form of the present technology is to provide a method and / or device for improving patient compliance with respect to respiratory therapy.

[0092] The device included in one form of the present technology includes: a display; a camera; a memory; and a processing system including at least one hardware processor coupled to the display, the camera and the memory. The processing system is configured to: receive one or more images including the patient together with a patient interface configured to engage with at least one airway of the patient and supply breathable gas received from a continuous positive airway pressure (CPAP) device to the patient; analyze the received one or more images; and based on the analysis, display on the display feedback for improving the fit and / or operation of the patient interface.

[0093] Another aspect of the present technology relates to a respiratory pressure therapy system that provides continuous positive airway pressure to a patient via a patient interface configured to engage at least one airway of the patient. The system includes a flow generator configured to generate a supply of breathable gas to be delivered to the patient via the patient interface; at least one sensor; a display; and a computing device. The computing device is configured to receive sensor data based on measured physical properties of the supply of breathable gas; control the flow generator based on the received sensor data to adjust the characteristics of the supply of breathable gas; receive an input indicating that assistance is needed using the patient interface; receive one or more images of the patient using the patient interface; analyze the received one or more images; and based on the analysis, display on the display an instruction to position the patient interface.

[0094] Another aspect of the present technology relates to a respiratory pressure therapy system that provides continuous positive airway pressure (CPAP) to a patient via a patient interface configured to engage at least one airway of the patient. The system includes: a flow generator configured to generate a supply of breathable gas to be delivered to the patient via the patient interface, the breathable gas being output from the flow generator at a pressure level above atmospheric pressure; at least one sensor configured to measure a physical quantity when the breathable gas is being supplied to the patient; a display; and a computing device including a memory and at least one hardware processor. The computing device is configured to: receive sensor data from the at least one sensor based on the measured physical properties of the supply of breathable gas; control the flow generator based on the received sensor data to adjust the characteristics of the supply of breathable gas delivered to the patient; receive an input indicating that assistance is needed using the patient interface; receive one or more images including the patient and the patient interface; analyze the received one or more images; and based on the analysis, display an instruction on the display to position the patient interface.

[0095] In an example, (a) the memory includes one or more reference images including the patient with the patient interface, and the displayed instructions are generated by a computing device based on a comparison between the one or more reference images and the one or more received images; (b) the computing device is coupled to a camera configured to capture the one or more reference images; (c) the computing device is configured to compare the one or more reference images and the one or more received images to determine an improper fitting position of the patient interface; (d) the computing device is configured to super-impose the correct position of the patient interface onto the one or more received images, and the displayed instructions include the one or more super-imposed images; (e) the system includes a remote computing system configured to determine an instruction to position the patient interface and to send the instruction to the computing device; (f) the remote computing system is configured to: receive the one or more images from the computing device; train a machine learning model for instructions for correct positioning of the patient interface; the instruction to position the patient interface is determined based on the trained machine learning model; (g) the computing device is further configured to receive an input indicating the type of the patient interface and to display, on a display, an instruction to use the type of the patient interface indicated by the input; (h) the computing device is configured to send the one or more received images to a remote processing system configured to perform machine learning using the one or more images; and / or (i) the instructions include text, images and / or graphics.

[0096] Another aspect of the technology relates to a non-transitory computer-readable storage medium storing instructions that, when used with a computing device, configure the computing device to control a continuous positive airway pressure (CPAP) device configured to generate a supply of breathable gas delivered to a patient via a patient interface configured to engage at least one airway of the patient. The breathable gas is output from a flow generator at a pressure level above atmospheric pressure, and the CPAP device is associated with at least one sensor configured to measure a physical quantity when the breathable gas is being supplied to the patient. The computing device includes at least one hardware processor, and the stored instructions include instructions configured to cause the computing device to: receive sensor data from at least one sensor based on the measured physical properties of the supply of breathable gas; control the flow generator based on the received sensor data to adjust the characteristics of the supply of breathable gas delivered to the patient; receive an input indicating that assistance is needed using the patient interface; receive one or more images including the patient and the patient interface; analyze the received one or more images; and based on the analysis, display on a display an instruction to position the patient interface.

[0097] Another aspect of the present technology relates to a device including: a display; a camera; a memory; and a processing system including at least one hardware processor coupled to the display, the camera, and the memory. The processing system is configured to: receive a notification identifying a type of patient interface configured to engage at least one airway of a patient and supply breathable gas received from a continuous positive airway pressure (CPAP) device to the patient; receive from the camera one or more images including the patient with the patient interface; analyze the received one or more images to determine a fit of the patient interface on the patient; and based on the analysis, display on the display feedback for improving the fit of the patient interface on the patient.

[0098] In an example, (a) the received notification identifying the type of patient interface is a user input; (b) the received notification identifying the type of patient interface is determined by the processing system based on an image including the patient interface; (c) the analysis includes comparing one or more received images to one or more reference images; (d) the one or more reference images include a patient together with the patient interface; (e) the one or more reference images include a plurality of reference points, and the analysis includes detecting reference points in the one or more received images and comparing the detected reference points to the plurality of reference points in one or more difference images; (f) the analysis includes extracting one or more indicators included in the patient interface from the one or more received images; (g) the one or more received images are captured from different positions and orientations of a camera; (h) the plurality of images are captured at different times, and the analysis includes comparing the plurality of images to determine a change in the positioning of the patient interface between the images captured at different times; (i) displaying feedback includes displaying at least one of the received images, and the processing system is configured to include in the displayed received image one or more visual indicators indicating a positioning on the patient interface where an improved fit of the patient interface is possible; (j) the processing system is configured to display an instruction to use the identified type of patient interface; (k) the analysis includes comparing the one or more received images to a model generated based on information received from other patients; (l) the analysis includes extracting features from the one or more received images and comparing the position and / or orientation of the features to a three-dimensional model of the patient interface; (m) the analysis includes comparing the one or more received images to a machine-trained model updated based on data received from other patients; (n) the device is a mobile phone, a tablet, or a remote control; (o) the processing system is further configured to receive sensor data from one or more sensors disposed on a surface of the patient interface or on a surface within the patient interface;(p) The processing system is further configured to perform an analysis and display feedback based on data received from the sensor; and / or (q) the sensor data is compared to a pre-set sensor value stored in the memory.

[0099] Another aspect of the technology relates to a non-transitory computer-readable storage medium storing instructions for use with a computing device. The stored instructions include instructions configured to cause the computing device to: receive a notification identifying a type of patient interface configured to engage at least one airway of a patient and supply breathable gas received from a continuous positive airway pressure (CPAP) device to the patient; receive from a camera one or more images including the patient with the patient interface; analyze the received one or more images to determine a fit of the patient interface on the patient; and based on the analysis, display on a display feedback for improving the fit of the patient interface on the patient.

[0100] Another aspect of the technology relates to a respiratory pressure therapy system that provides continuous positive airway pressure (CPAP) to a patient via a patient interface configured to engage at least one airway of the patient. The system includes: a flow generator configured to generate via the patient interface a supply of breathable gas to be delivered to the patient, the breathable gas being output from the flow generator at a pressure level above atmospheric pressure; a display; and a computing device including a memory and at least one hardware processor. The computing device is configured to: control the flow generator to adjust characteristics of the supply of breathable gas delivered to the patient; receive sensor data from one or more patient interface sensors; compare the received sensor data to a pre-set value in the memory; and based on the comparison, display on the display an instruction to position the patient interface.

[0101] In an example, (a) the memory includes one or more images including the patient with the patient interface, and the displayed instructions include displaying one or more images based on a comparison; (b) the computing device is coupled to a camera configured to capture one or more images of the patient with the patient interface; (c) the computing device is configured to compare one or more reference images stored in the memory with the one or more captured images to determine an improper fitting position of the patient interface; (d) the computing device is configured to super-impose the correct position of the patient interface onto the one or more captured images, and the displayed instructions include the one or more super-imposed images; (e) further includes a remote computing system configured to determine an instruction to position the patient interface and to send the instruction to the computing device; (f) the computing device is further configured to receive an input indicating the type of the patient interface and to display on the display an instruction to use the type of the patient interface indicated by the input; (g) at least one of the one or more patient interface sensors is disposed on the surface of the patient interface; (h) at least one of the one or more patient interface sensors is a pressure sensor configured to measure the pressure inside the mask of the patient interface; (i) at least one of the one or more patient interface sensors is a sensor configured to measure the physical properties of the supply of breathable gas in the mouth cushion or nose cushion of the patient interface; and / or (j) at least one of the one or more patient interface sensors is disposed on the surface or inside of the strap of the patient interface.

[0102] Another aspect of the technology relates to a program for troubleshooting and includes: instructing a user to take an image or video, generating a result by comparing the image or video with a baseline video, and instructing the user to take an action based on the result.

[0103] Another aspect of the technology relates to a program for troubleshooting and includes: instructing a user to take an image or video, generating a result by comparing the image or video with a baseline image or video, and instructing the user to take an action based on the result.

[0104] Another aspect of the technology relates to a non-transitory computer-readable storage medium storing instructions for use with a computing device. The instructions included in the stored instructions, when executed, cause the computing device to: display an instruction to take an image or video, generate a result by comparing the captured image or video with a baseline image or video, and display an instruction for an action based on the result.

[0105] In an example, (a) the instructions further included in the stored instructions, when executed, cause the computing device to: in response to an input captured image or video; (b) the captured image or video includes a user and patient interface; and / or (c) the instructions further included in the stored instructions, when executed, cause the computing device to: receive an input indicating the type of patient interface, and in response to the input, display an instruction to use the patient interface.

[0106] Another aspect of the technology relates to a device including: a display; a camera; a memory; and a processing system including at least one hardware processor coupled to the display, the camera, and the memory. The processing system is configured to: capture one or more images including a patient using the camera; determine characteristics of facial features from the captured images; transmit the determined characteristics of the facial features to a remote processing system for analysis; receive, from the remote processing system, data regarding one or more settings of a patient interface configured to engage at least one airway of the patient and supply breathable gas received from a continuous positive airway pressure (CPAP) device to the patient; and display, on the display, an instruction to adjust one or more settings of the patient interface based on the received data regarding the one or more settings of the patient interface.

[0107] In an example, (a) the processing system is further configured to receive user input identifying the type of patient interface; and transmit the type of patient interface to a remote processing system for analysis; (b) the processing system is further configured to: receive from a camera one or more second images including a patient with the patient interface; analyze the received one or more second images to determine a fit of the patient interface on the patient; and display on a display feedback for improving the fit of the patient interface on the patient based on the analysis and received data regarding one or more settings of the patient interface; (c) the analysis includes comparing the received one or more second images to one or more reference images; (d) the one or more reference images include patients wearing the patient interface; (e) the one or more reference images include a plurality of reference points, and the analysis includes detecting reference points in the received one or more second images and comparing the detected reference points to the plurality of reference points in one or more difference images; (f) the analysis includes extracting from the received one or more second images one or more indicators included on the patient interface; (g) the one or more indicators include a plurality of indicators provided on one or more straps of the patient interface; (h) the one or more indicators include at least one indicator provided on a mask of the patient interface; (i) the one or more indicators include an indicator provided on a connector configured to connect at least one of the straps to the mask of the patient interface; (j) the processing system is further configured to determine a force applied from one or more straps based on characteristics of one or more indicators within one or more of the second images; (k) the processing system is further configured to perform a comparison of forces applied from different straps of the patient interface based on characteristics of one or more indicators included within the different straps; (l) the processing system is further configured to indicate that one or more straps are too tight based on characteristics of one or more indicators within one or more of the straps;(m) The analysis performed by the remote processing system includes comparing one or more received images with a model generated based on information received from a plurality of other patients; and / or (o) the device is a respiratory pressure therapy device that provides continuous positive airway pressure (CPAP) to a patient, the respiratory pressure therapy device including: a flow generator configured to generate a supply of breathable gas to be delivered to the patient via a patient interface, the breathable gas being output from the flow generator at a pressure level above atmospheric pressure; and at least one sensor configured to measure a physical quantity when the breathable gas is being supplied to the patient.;

[0108] Another aspect of the present technology relates to a non-transitory computer-readable storage medium storing instructions for use with a computing device. The stored instructions include instructions configured to cause the computing device to: receive one or more images including a patient captured by a camera; determine characteristics of facial features from the captured images; transmit the determined characteristics of the facial features to a remote processing system for analysis; receive, from the remote processing system, data regarding one or more settings of a patient interface configured to engage at least one airway of the patient and supply breathable gas received from a continuous positive airway pressure (CPAP) device to the patient; and output an instruction to adjust one or more settings of the patient interface based on the received data regarding the one or more settings of the patient interface.

[0109] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed with a peripheral shape that is complementary to the shape of the intended wearer.

[0110] One aspect of one form of the present technology is a method of manufacturing an apparatus.

[0111] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very skillful or lack insight, or people with limited experience in using this type of medical device.

[0112] One aspect of a form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).

[0113] One aspect of a form of the present technology is a patient interface that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning equipment is required. One aspect of a form of the present technology is a humidifier tank that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning equipment is required.

[0114] The methods, systems, devices, and apparatuses described can be implemented to improve functions in a processor (e.g., the functions of a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory therapy device). Furthermore, the methods, systems, devices, and apparatuses described enable improvements in the technical field of the automatic management, monitoring, and / or treatment of respiratory diseases (e.g., sleep apnea).

[0115] Of course, some of the above aspects can form sub-aspects of the present technology. Also, various combinations of one of the diverse sub-aspects and / or aspects can be made, which can also constitute further aspects or sub-aspects of the present technology.

[0116] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

Brief Description of the Drawings

[0117] 4 Brief Description of the Drawings The present technology is illustrated by way of non-limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements. 4.1 Respiratory Therapy System

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DETAILED DESCRIPTION OF THE INVENTION

[0118] 5 DETAILED DESCRIPTION OF EXAMPLES OF THE PRESENT TECHNOLOGY

[0119] Before further elaborating on the present technology, it should be understood that the present technology is not limited to the specific examples that may be described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific examples described herein and are not limiting.

[0120] The following description is provided in relation to various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, any single feature or combination of features in any of these examples may constitute a further example. 5.1 Treatment

[0121] In one form, the present technology includes a method for treating a respiratory disorder. The method includes applying a positive pressure to the inlet of the airway of patient 1000.

[0122] In a particular example of the present technology, an air supply at positive pressure is provided to the nasal passage of the patient via one or both of the nostrils.

[0123] In a particular example of the present technology, mouth breathing is restricted, limited, or impeded. 5.2 Respiratory Therapy System

[0124] In one form, the present technology includes a respiratory therapy system for the treatment of a respiratory disorder. The respiratory therapy system may include an RPT device 4000 that supplies an air flow to patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800. 5.3 Patient Interface

[0125] The non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional modalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation section 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional modalities can be provided by one or more physical components. In some forms, one physical component can provide one or more functional modalities. In use, the seal-forming structure 3100 is arranged to surround the entrance(s) to the patient's airway 1000 so as to maintain a positive pressure at the entrance(s) to the patient's airway. Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0126] The non-sealing patient interface 3800 is in the form of a nasal cannula including nasal prongs 3810a and 3810b, which can deliver air to each nostril of the patient 1000 via their respective orifices at their tips. Such nasal prongs often do not form a seal with the inner or outer skin surface of the nostril. The air to the nasal prongs is delivered from one or more air supply lumens 3820a and 3820b. These are connected to the nasal cannula 3800. The lumens 3820a, 3820b lead from the nasal cannula 3800 to a respiratory therapy device via an air circuit. The non-sealing patient interface 3800 is particularly suitable for the provision of flow therapy in which the RPT device generates an air flow at a controlled flow rate rather than a controlled pressure. The non-sealing patient interface 3800 is provided with a "ventilation section" through which excess air flow escapes to the surroundings. This "ventilation section" is a passage between the ends of the prongs 3810a and 3810b of the cannula 3800 and extends to the atmosphere through the patient's nostrils.

[0127] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0128] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the surroundings.

[0129] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the surroundings.

[0130] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the surroundings. 5.3.1 Seal formation structure

[0131] In one embodiment of the present technology, the seal formation structure 3100 may provide a target seal formation area and further provide a cushioning function. The target seal formation area is an area where sealing can occur in the seal formation structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) can vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0132] In one embodiment, the target seal formation area is disposed on the outer surface of the seal formation structure 3100.

[0133] In a particular embodiment of the present technology, the seal formation structure 3100 is composed of a biocompatible material (e.g., silicone rubber).

[0134] The seal formation structure 3100 according to the present technology may be composed of a soft, flexible and elastic material (e.g., silicone).

[0135] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate different sizes and / or ranges of shapes. For example, the system may include one form of the seal-forming structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head. 5.3.1.1 Sealing mechanism

[0136] In one form, the seal-forming structure includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can act on its underside in easy response to the system positive pressure within the plenum chamber 3200 to form a tight sealing engagement with the surface. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilization structure.

[0137] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm). This member extends around the peripheral length of the plenum chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0138] In one form, the seal-forming structure may include a compression seal or a gasket seal. In use, the compression seal or gasket seal is constructed and arranged to be in a compressed state, for example, due to the elastic tension in the positioning and stabilization structure.

[0139] In one form, the seal-forming structure includes a tension portion. In use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

[0140] In one form, the seal-forming structure includes a region having an adhesive surface or an adhesive bonding surface.

[0141] In certain forms of the present technology, the seal-forming structure can include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension portion, and a portion having an adhesive surface or an adhesive bonding surface. 5.3.1.2 Nasal bridge or nasal sill region

[0142] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

[0143] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge region or the nasal sill region of the patient's face during use. 5.3.1.3 Upper lip region

[0144] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the upper lip region (i.e., the upper lip) of the patient's face during use.

[0145] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face during use. 5.3.1.4 Jaw region

[0146] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the jaw region of the patient's face during use.

[0147] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the jaw region of the patient's face during use. 5.3.1.5 Forehead region

[0148] In one form, the seal-forming structure forms a seal on the forehead region of the patient's face during seal use. In such a form, the plenum chamber can cover the eyes during use. 5.3.1.6 Nasal pillows

[0149] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and arranged to form a seal with each nostril of the patient's nose.

[0150] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the lower side of the patient's nose, the stem, and a flexible region on the lower side of the frustum of the cone, connecting the frustum of the cone to the stem. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible region may function to facilitate a freely jointed structure. The freely jointed structure corresponds to the mutual movement of both the displacement and the angle of the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone can be displaced axially towards the structure to which the stem is connected. 5.3.2 Plenum chamber

[0151] The plenum chamber 3200 has a periphery shaped complementary to the surface profile of an average person's face in the region where a seal is formed during use. During use, the peripheral edge of the plenum chamber 3200 is positioned close to the adjacent surface of the face. The actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend around the entire periphery of the edge of the plenum chamber 3200 during use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0152] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye during use. In other words, the eye is outside the pressurized space defined by the plenum chamber. In such forms, treatment compliance can be improved because pressure is often reduced and / or wearer comfort is increased.

[0153] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). Use of a transparent material can reduce the pressure exerted by the patient interface and can assist in improving compliance with treatment. Use of a transparent material can assist a clinician in viewing the placement and function of the patient interface.

[0154] In certain forms of the present technology, the plenum chamber 3200 is composed of a translucent material. Use of a translucent material can reduce the pressure exerted by the patient interface and can assist in improving compliance with treatment. 5.3.3 Positioning and Stabilization Structure

[0155] The seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in a sealed position by a positioning and stabilization structure 3300 during use.

[0156] In one form, the positioning and stabilization structure 3300 provides at least sufficient holding force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0157] In one form, the positioning and stabilization structure 3300 provides sufficient holding force to overcome the gravitational pull on the patient interface 3000.

[0158] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube pulling or accidental interference with the patient interface).

[0159] In one form of the present technology, a positioning and stabilization structure 3300 configured to be worn by a patient during sleep is provided. In one example, the positioning and stabilization structure 3300 has a low-profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0160] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky so as not to interfere with a patient sleeping in a supine sleep position with the back of the patient's head resting on a pillow.

[0161] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky so as not to interfere with a patient sleeping in a lateral sleep position with the side of the patient's head resting on a pillow.

[0162] In one form of the present technology, the positioning and stabilization structure 3300 includes a release portion disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This release portion is not resistant to compression and can be, for example, a flexible or flimsy strap. The release portion is constructed and arranged so as to avoid a situation where, when the patient lies with their head on a pillow, the presence of the release portion causes a force to be transmitted along the positioning and stabilization structure 3300 to the rear, interfering with the seal.

[0163] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous such that moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0164] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut when in use and direct the force to bring the seal-forming structure into close contact with a part of the patient's face. In one example, the strap can be configured as a tie.

[0165] In one form of the present technology, the positioning and stabilization structure includes a first tie, and the first tie is constructed and arranged such that at least a part of its lower edge moves upward and covers a part of the parietal bone without covering the occipital bone when in use and reaches the upper ear base point of the patient's head.

[0166] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a second tie. The second tie is constructed and arranged such that at least a part of its upper edge passes below the lower ear base point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head when in use.

[0167] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move away from each other in a separating direction.

[0168] In certain forms of the technology, the positioning and stabilization structure 3300 includes straps that are bendable and, for example, non-rigid. An advantage of this aspect is that the straps are more comfortable when the patient lies on their side during sleep.

[0169] In certain forms of the technology, the positioning and stabilization structure 3300 includes straps configured to be breathable such that water vapor can pass through them.

[0170] In certain forms of the technology, a system is provided that includes more than one positioning and stabilization structure 3300. Each positioning and stabilization structure 3300 is configured to provide a holding force to accommodate different sizes and / or ranges of shapes. For example, the system may include a form of the positioning and stabilization structure 3300 suitable for a large-sized head rather than a small-sized head and another form suitable for a small-sized head rather than a large-sized head. 5.3.4 Ventilation section

[0171] In one form, the patient interface 3000 includes a ventilation section 3400 configured and arranged to allow the expulsion of exhaled gas (e.g., carbon dioxide).

[0172] In certain forms, the ventilation section 3400 is configured to allow a continuous ventilation flow from the inside of the plenum chamber 3200 to the ambient when the pressure in the plenum chamber is positive relative to the ambient. The ventilation section 3400 is configured such that, during use, while maintaining the therapeutic pressure in the plenum chamber, the magnitude of the ventilation flow rate is large enough to reduce rebreathing of exhaled CO2 by the patient.

[0173] One form of the ventilation section 3400 according to the technology includes a plurality of holes (e.g., from about 20 to about 80 holes or from about 40 to about 60 holes or from about 45 to about 55 holes).

[0174] The ventilation portion 3400 can be disposed within the plenum chamber 3200. Alternatively, the ventilation portion 3400 is disposed within a decoupling structure (e.g., a swivel). 5.3.5 Decoupling structure(s)

[0175] In one form, the patient interface 3000 includes at least one decoupling structure (e.g., a swivel or ball-and-socket). 5.3.6 Connection port

[0176] The connection port 3600 enables connection to the air circuit 4170. 5.3.7 Forehead support

[0177] In one form, the patient interface 3000 includes a forehead support 3700. 5.3.8 Anti-asphyxia valve

[0178] In one form, the patient interface 3000 includes an anti-asphyxia valve. 5.3.9 Port

[0179] In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the characteristics of the gas (e.g., pressure) within the plenum chamber 3200. 5.4 RPT device

[0180] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, either wholly or in part). The RPT device 4000 can be configured to generate an air flow that is delivered to a patient's airway for treatment of one or more of the respiratory diseases described anywhere in this document.

[0181] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow 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.

[0182] The RPT device may have an external housing 4010. The external housing 4010 is formed by two parts, an upper part 4012 and a lower part 4014. Further, the external 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.

[0183] The pneumatic path of the pneumatic RPT device 4000 may include one or more air path items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0184] One or more of the air path items may be arranged within a removable integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be arranged within the external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or is formed as part of the chassis 4016.

[0185] The RPT device 4000 can include an electrical power source 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. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 can include more than one PCBA 4202. 5.4.1 RPT device mechanical and pneumatic components

[0186] The RPT device can include one or more of the following components in an integrated unit. In an alternative form, one or more of the following components can be arranged as separate individual units. 5.4.1.1 Air filter(s)

[0187] The RPT device according to one form of the present technology can include an air filter 4110 or a plurality of air filters 4110.

[0188] In one form, the inlet air filter 4112 is disposed at the beginning of the upstream of the pneumatic path of the pressure generator 4140.

[0189] In one form, the outlet air filter 4114 (e.g., antibacterial factor) is disposed between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800. 5.4.1.2 Muffler(s)

[0190] The RPT device according to one form of the present technology can include a muffler 4120 or a plurality of mufflers 4120.

[0191] In one form of the present technology, the inlet muffler 4122 is disposed above the pressure generator 4140 within the pneumatic path.

[0192] In one form of the present technology, the outlet muffler 4124 is disposed between the pressure generator 4140 and the patient interface 3000 or 3800 in the pneumatic path. 5.4.1.3 Pressure generator

[0193] In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impeller may be disposed within a volute. The blower can deliver the air supply at a speed of, for example, up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when performing respiratory pressure therapy. The blower may be described in any one of the following patents or patent applications, which are hereby incorporated by reference in their entirety: U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479, and PCT Patent Application Publication WO2013 / 020167.

[0194] The pressure generator 4140 is under the control of the therapy device controller 4240.

[0195] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows. 5.4.1.4 Transducer(s)

[0196] The transducer may be provided inside the RPT device or outside the RPT device. The external transducer may be disposed, for example, on the air circuit or may form part of the air circuit (e.g., the patient interface). The external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves the data RPT device).

[0197] In one aspect of the present technology, one or more transducers 4270 may be disposed upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of the characteristics of the air flow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0198] In one aspect of the present technology, one or more transducers 4270 may be disposed in the vicinity of the patient interface 3000 or 3800.

[0199] In one aspect, the signal from the transducer 4270 may be filtered (e.g., by low-pass, high-pass, or band-pass filtering). 5.4.1.4.1 Flow Rate Sensor

[0200] The flow rate sensor 4274 according to the present technology may be based on a differential pressure transducer (e.g., SDP600 series differential pressure transducer from SENSIRION).

[0201] In one aspect, the signal generated by the flow rate sensor 4274 indicative of the flow rate is received by the central controller 4230. 5.4.1.4.2 Pressure Sensor

[0202] The pressure sensor 4272 according to the present technology may be disposed 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 NPA series from GENERAL ELECTRIC.

[0203] In one form, the signal generated from the pressure sensor 4272 is received by the central controller 4230. 5.4.1.4.3 Motor Speed Transducer

[0204] In one form of the technology, a motor speed converter 4276 can be used to determine the rotational speed of motor 4144 and / or blower 4142. The motor speed signal from motor speed converter 4276 can be provided to treatment device controller 4240. The motor speed converter 4276 can be, for example, a speed sensor (e.g., a Hall effect sensor). 5.4.1.5 Anti-spillback valve

[0205] In one form of the technology, an anti-spillback valve 4160 can be disposed between humidifier 5000 and pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to motor 4144). 5.4.2 RPT device electrical components 5.4.2.1 Power supply

[0206] Power supply 4210 can be disposed inside or outside the external housing 4010 of RPT device 4000.

[0207] In one form of the technology, power supply 4210 supplies power only to RPT device 4000. In another form of the technology, power is provided from power supply 4210 to both RPT device 4000 and humidifier 5000. 5.4.2.2 Input device

[0208] In one form of the technology, RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials that enable a human to interact with the device. The buttons, switches, or dials can be physical devices or software devices that can be accessed via a touch screen. The buttons, switches, or dials can be physically connected to the external housing 4010 in one form, or wirelessly communicate with a receiver electrically connected to the central controller 4230 in another form.

[0209] In one form, the input device 4220 can be constructed and arranged to enable a human to select values and / or menu options.

[0210] In one example, an imaging sensor that may be included in the input device 4220 is configured to capture an image and / or a series of images (e.g., video). 5.4.2.3 Central Controller

[0211] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0212] Suitable processors may include x86 INTEL processors, which are processors based on the ARM (trademark) Cortex (trademark)-M processors from ARM Holdings (e.g., the S (trademark) 32 series of microcontrollers from STMicroelectronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., the STR9 series of microcontrollers from STMicroelectronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by Texas Instruments) may also be suitable.

[0213] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0214] In one form, the central controller 4230 is an application-specific integrated circuit. In another form, the central controller 4230 includes individual electronic components.

[0215] The central controller 4230 can be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and the humidifier 5000.

[0216] The central controller 4230 may be configured to provide an output signal(s) to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0217] In some forms of the technology, the central controller 4230 is configured to embody one or more methods described herein (e.g., one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer-readable storage medium (e.g., the memory 4260)). In some forms of the technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the technology, some methods may be performed by remotely located devices. For example, a remotely located device may determine ventilator control settings or detect respiratory-related events by analyzing recorded data (e.g., from any of the sensors described herein). 5.4.2.4 Clock

[0218] The RPT device 4000 may include a clock 4232 connected to the central controller 4230. 5.4.2.5 Therapy Device Controller

[0219] In one form of the technology, the therapy device controller 4240 is a therapy control module 4330 and forms part of the algorithm 4300 executed by the central controller 4230.

[0220] In one form of the technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, an MC33035 brushless DC motor controller manufactured by ONSEMI is used. 5.4.2.6 Protection Circuit

[0221] One or more protection circuits 4250 according to the technology may include an electrical protection circuit, a temperature and / or pressure safety circuit. 5.4.2.7 Memory

[0222] According to one aspect of the present technology, the RPT device 4000 includes a memory 4260 (e.g., a non-volatile memory). In some aspects, the memory 4260 may include a battery-backed static RAM. In some aspects, the memory 4260 may include a volatile RAM.

[0223] The memory 4260 may be disposed on the PCBA 4202. The memory 4260 may be in the form of an EEPROM or a NAND flash.

[0224] Additionally or alternatively, the RPT device 4000 includes a removable memory 4260 (e.g., a memory card manufactured according to the Secure Digital (SD) standard).

[0225] In one aspect of the present technology, the memory 4260 functions as a non-transitory computer-readable storage medium. Computer program instructions (e.g., one or more algorithms 4300) representing one or more of the methods described herein are recorded on this recording medium. 5.4.2.8 Data Communication System

[0226] In one aspect of the present technology, a data communication interface 4280 is provided and connected to the central controller 4230. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0227] In one aspect, the data communication interface 4280 is part of the central controller 4230. In another aspect, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0228] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can use wired communication (e.g., via Ethernet or fiber optic) or a wireless protocol (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0229] In one form, the local external communication network 4284 uses one or more communication standards (e.g., Bluetooth® or consumer infrared protocol).

[0230] In one form, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In one form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 can be accessible to appropriately authorized persons (e.g., clinicians).

[0231] The local external device 4288 can be a personal computer, a mobile phone, a tablet, or a remote control. 5.4.2.9 Optional display, output device including alarms

[0232] The output device 4290 according to the present technology can take one or more forms of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light emitting diode (LED) display. 5.4.2.9.1 Display driver

[0233] The display driver 4292 receives as input the characters, symbols, or images to be displayed on the display 4294 and converts them into commands to display these characters, symbols, or images on the display 4294. 5.4.2.9.2 Display

[0234] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 can be an 8-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the digit "0") into eight logic signals indicating whether each of the eight segments should be activated to display the particular character or symbol. 5.4.3 RPT Device Algorithm

[0235] As described above, in some forms of the present technology, the central controller 4230 can be configured to implement one or more algorithms 4300 represented as a computer program recorded in a non-transitory computer-readable storage medium (e.g., the memory 4260). These algorithms 4300 are generally grouped into groups called modules.

[0236] In other forms of the present technology, some or all of the algorithm 4300 can be implemented by a controller of an external device such as the local external device 4288 or the remote external device 4286. In such forms, data representing the input signals and / or intermediate algorithm outputs necessary for the portion of the algorithm 4300 that is executed by the external device can be communicated to the external device via the local external communication network 4284 or the remote external communication network 4282. In such forms, the portion of the algorithm 4300 that is executed by the external device can be represented as a computer program stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute a portion of the algorithm 4300.

[0237] In such a form, treatment parameters generated by an external device via the treatment engine module 4320 (in such a form, a part of the algorithm 4300 is executed by the external device) can be transmitted to the central controller 4230 and passed to the treatment control module 4330. 5.4.3.1 Pretreatment Module

[0238] The pretreatment module 4310 according to one form of the present technology receives, as an input, a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272), and performs one or more process steps for calculating one or more output values. These output values are used as inputs to another module (e.g., the treatment engine module 4320).

[0239] In one form of the present technology, the output values include the interface pressure Pm, the respiratory flow rate Qr, and the leakage flow rate Ql.

[0240] In various forms of the present technology, the pretreatment module 4310 includes one or more of the following algorithms: interface pressure estimation 4312, ventilation flow rate estimation 4314, leakage flow rate estimation 4316, and respiratory flow rate estimation 4318. 5.4.3.1.1 Interface Pressure Estimation

[0241] In one embodiment of the present technology, the interface pressure estimation algorithm 4312 receives, as an input, a signal indicating the pressure (device pressure Pd) in the pneumatic path near the outlet of the pneumatic block from the pressure sensor 4272, and receives, as an input, a signal indicating the flow rate (device flow rate Qd) of the air flow exiting the RPT device 4000 from the flow rate sensor 4274. The device flow rate Qd that does not include any supplementary gas 4180 can be used as the total flow rate Qt. The interface pressure algorithm 4312 estimates the pressure drop ΔP through the air circuit 4170. The dependence of the pressure drop ΔP on the total flow rate Qt can be modeled for a specific air circuit 4170 by the pressure drop characteristic ΔP(Q). Next, the interface pressure estimation algorithm 4312 provides, as an output, the estimated pressure Pm in the patient interface 3000 or 3800. The pressure Pm in the patient interface 3000 or 3800 can be estimated as a value obtained by subtracting the air circuit pressure drop ΔP from the device pressure Pd. 5.4.3.1.2 Estimation of ventilation flow rate

[0242] In one embodiment of the present technology, the ventilation flow rate estimation algorithm 4314 receives, as an input, the estimated pressure Pm in the patient interface 3000 or 3800 from the interface pressure estimation algorithm 4312, and estimates the ventilation flow rate Qv of the air from the ventilation part 3400 in the patient interface 3000 or 3800. The dependence of the ventilation flow rate Qv on the interface pressure Pm at a specific ventilation part 3400 during use can be modeled by the ventilation characteristic Qv(Pm). 5.4.3.1.3 Estimation of leakage flow rate

[0243] In one embodiment of the present technology, the leakage flow rate estimation algorithm 4316 receives the total flow rate Qt and the ventilation flow rate Qv as inputs, and provides, as an output, the estimation of the leakage flow rate Ql. In one embodiment, the leakage flow rate estimation algorithm estimates the leakage flow rate Ql by calculating the difference average between the total flow rate Qt and the ventilation flow rate Qv over a period long enough to include several breathing cycles (e.g., about 10 seconds).

[0244] In one form, the leak flow rate estimation algorithm 4316 receives the total flow rate Qt, the ventilation flow rate Qv, and the estimated pressure Pm in the patient interface 3000 or 3800 as inputs, and provides the leak flow rate Ql as an output by calculating the leak conductance and determining the leak flow rate Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered non-ventilation flow rate equal to the difference between the total flow rate Qt and the ventilation flow rate Qv and the low-pass filtered square root of the pressure Pm, and the low-pass filter time constant has a sufficient value to include several respiratory cycles (e.g., about 10 seconds). The leak flow rate Ql can be estimated as a function of the product of the leak conductance and the pressure Pm. 5.4.3.1.4 Respiratory Flow Rate Estimation

[0245] In one form of the present technology, the respiratory flow rate estimation algorithm 4318 receives the total flow rate Qt, the ventilation flow rate Qv, and the leak flow rate Ql as inputs, and estimates the air respiratory flow rate Qr to the patient by subtracting the ventilation flow rate Qv and the leak flow rate Ql from the total flow rate Qt. 5.4.3.2 Treatment Engine Module

[0246] In one form of the present technology, the treatment engine module 4320 receives one or more of the pressure Pm in the patient interface 3000 or 3800 and the air respiratory flow rate Qr to the patient as inputs, and provides one or more treatment parameters as outputs.

[0247] In one form of the present technology, the treatment parameter is the treatment pressure Pt.

[0248] In one form of the present technology, the treatment parameters are one or more of the amplitude of the pressure change, the base pressure, and the target ventilation.

[0249] 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 limit determination 4324, apnea / hypopnea determination 4325, snore determination 4326, airway patency determination 4327, target ventilation determination 4328, and treatment parameter determination 4329. 5.4.3.2.1 Phase determination

[0250] In one form of the technology, the RPT device 4000 does not determine a phase.

[0251] In one form of the technology, the phase determination algorithm 4321 receives a signal indicative of the respiratory flow rate Qr as an input and provides the phase of the current respiratory cycle of the patient 1000 as an output Φ.

[0252] In some forms, the phase output Φ, known as discrete phase determination, is a discrete variable. According to one embodiment of the discrete phase determination, a binary phase output Φ having a value of inspiration or expiration is obtained. This value is represented as values of, for example, 0 revolutions and 0.5 revolutions respectively when the start of each of spontaneous inspiration and expiration is detected. The RPT device 4000 that "triggers" and "cycles" effectively performs discrete phase determination. This is because the trigger point and the cycle point are the instants at which the phase changes from expiration to inspiration and from inspiration to expiration respectively. In one embodiment of the binary phase determination, the phase output Φ has a discrete value of 0 when the respiratory flow rate Qr has a value exceeding a positive threshold (thereby "triggering" the RPT device 4000), and has a discrete value of 0.5 revolutions (thereby "cycling" the RPT device 4000) when the value of the respiratory flow rate Qr is a more negative value than a negative threshold. The inspiratory time Ti and the expiratory time Te can be typical values estimated over many respiratory cycles of the time spent with the phase Φ equal to 0 (indicating inspiration) and 0.5 (indicating expiration) respectively.

[0253] Another embodiment of discrete phase determination results in a three-valued phase output Φ with one value of inspiration, apnea during inspiration, and expiration.

[0254] In other forms, the phase output Φ, known as continuous phase determination, is a continuous variable that varies, for example, between 0 revolutions to 1 revolution or 0 to 2π radians. The RPT device 4000 that performs continuous phase determination can be triggered and cycled when the continuous phase reaches 0 revolutions and 0.5 revolutions respectively. In one embodiment of continuous phase determination, the continuous value Φ of the phase is determined using fuzzy logic analysis of the respiratory flow rate Qr. The continuous value of the phase determined in this embodiment is often referred to as the "fuzzy phase". In one embodiment of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr: 1. If the respiratory flow rate increases rapidly after becoming zero, the phase is 0 revolutions. 2. If the respiratory flow rate is a large positive value and stable, the phase is 0.25 revolutions. 3. If the respiratory flow rate is zero and decreases rapidly, the phase is 0.5 revolutions. 4. If the respiratory flow rate is a large negative value and stable, the phase is 0.75 revolutions. 5. If the respiratory flow rate is zero and stable, and the absolute value of the 5-second low-pass filtered respiratory flow rate is large, the phase is 0.9 revolutions. 6. If the respiratory flow rate is positive and the phase is expiration, the phase is 0 revolutions. 7. If the respiratory flow rate is negative, the phase is inspiration, and the phase is 0.5 revolutions. 8. If the absolute value of the 5-second low-pass filtered respiratory flow rate is large, the phase increases at a constant rate equal to the patient's respiratory rate low-pass filtered by a time constant of 20 seconds.

[0255] The output of each rule can be represented as a vector whose phase is the result of the rule and whose magnitude is the fuzzy range for which the rule is true. Fuzzy ranges such as "large" and "stable" for the respiratory flow rate are determined by appropriate membership functions. The results of the rules are represented as vectors and then combined by some functions such as taking the centroid. In such combinations, the rules may be weighted equally or may be weighted in different ways.

[0256] In another embodiment of the continuous phase determination, the phase Φ is first individually estimated from the respiratory flow rate Qr as described above, similar to the inhalation time Ti and the exhalation time Te. The continuous phase Φ at any instant is determined as the value obtained by adding half of the ratio of the inhalation time Ti elapsed from the preceding trigger instant or the ratio of the exhalation time Te elapsed from the preceding cycle instant for 0.5 revolutions (whichever is the more recent instant). 5.4.3.2.2 Waveform determination

[0257] In one form of the present technology, the treatment parameter determination algorithm 4329 provides a substantially constant treatment pressure throughout the patient's respiratory cycle.

[0258] In another form of the present 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 according to the waveform template Π(Φ).

[0259] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ). The waveform template has values within the range of [0,1] for the range of phase values Φ provided by the phase determination algorithm 4321 that is intended to be used by the treatment parameter determination algorithm 4329.

[0260] In one form, suitable for a phase that takes discrete or continuous values, the waveform template Π(Φ) is a square wave template, having a value of 1 for phase values up to 0.5 rotations and a value of 0 for phase values exceeding 0.5 rotations. In one form, suitable for a phase that takes continuous values, the waveform template Π(Φ) includes two smoothly curved portions (i.e., a smooth (e.g., rising cosine) rise from 0 to 1 for phase values up to 0.5 rotations and a smooth (e.g., exponential) fall from 1 to 0 for phase values exceeding 0.5 rotations). In one form, suitable for a phase that takes continuous values, the waveform template Π(Φ) is based on a square wave but has a smooth rise from 0 to 1 for phase values up to a “rise time” lower than 0.5 rotations and a smooth fall from 1 to 0 for phase values within the “fall time” after 0.5 rotations, having a “fall time” lower than 0.5 rotations.

[0261] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates according to the settings of the RPT device. Each waveform template Π(Φ) in the library may be provided as a look-up table of values Π for phase values Φ. In other forms, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) “on the fly” using a predetermined functional form, perhaps parameterized by one or more parameters (e.g., the time constant of the exponential curve portion). The parameters of the functional form may be predetermined or may depend on the current state of the patient 1000.

[0262] In some forms of the present technology suitable for the discrete binary phases of inspiration (Φ = 0 rotations) or expiration (Φ = 0.5 rotations), the waveform determination algorithm 4322 calculates the waveform template Π "on the fly" as a function of the discrete phase Φ and time t measured from the most recent trigger instant. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ,t) in two parts (inspiration and expiration) as follows.

[0263] [Number]

[0264] Here, Πi(t) and Πe(t) are the inspiration part and expiration part of the waveform template Π(Φ,t). In one such form, the inspiration part Πi(t) of the waveform template is a smooth rise from 0 to 1 parameterized by the rise time, and the expiration part Πe(t) of the waveform template is a smooth fall from 1 to 0 parameterized by the fall time. 5.4.3.2.3 Ventilation determination

[0265] In one form of the present technology, the ventilation determination algorithm 4323 receives the respiratory flow Qr as an input and determines a measurement indicative of the current patient ventilation Vent.

[0266] In some embodiments, the ventilation determination algorithm 4323 determines a measurement of the ventilation Vent, which is an estimate of the actual patient ventilation. As one such embodiment, it may take half the absolute value of the respiratory flow Qr, which is optionally filtered by a low-pass filter (e.g., a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz).

[0267] In other embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is highly proportional to the actual patient ventilation. In such an embodiment, the peak respiratory flow rate Qpeak is estimated during the inspiratory portion of the cycle. Through the above and many other procedures including sampling of the respiratory flow rate Qr, a measurement that is highly proportional to ventilation is obtained, but for these measurements, the variation in the flow waveform shape is not so large (where the shapes of two breaths are taken to be similar when the flow waveforms of the breaths normalized in time and amplitude are similar). To give some simple examples, there are the median of the positive respiratory flow rates, the median of the absolute values of the respiratory flow rates, and the standard deviation of the flow rates. Any linear combination of any order statistics of the absolute values of the respiratory flow rates using positive coefficients (and even some using both positive and negative coefficients) is approximately proportional to ventilation. As another example, it is the average of the respiratory flow rates at the central K-th percentage of the inspiratory portion with respect to time, where 0 < K < 1. When the flow shape is constant, there are any number of measurements that are highly proportional to ventilation. 5.4.3.2.4 Determination of Inspiratory Flow Limitation

[0268] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the range of inspiratory flow limitation.

[0269] In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow rate signal Qr as an input and provides, as an output, a measurement of the range in which the inspiratory portion of the breath indicates an inspiratory flow limitation.

[0270] In one aspect of the present technique, the inhalation portion of each breath is identified by a zero-crossing detector. A plurality of (e.g., 65) equally spaced points are indicative of time points and are interpolated by an interpolator along an inspiratory flow-time curve for each breath. The curve described by these points is then scaled by a scaler to have unit length (duration / period) and unit area, thereby removing the effects due to changes in respiratory rate and depth. Next, the scaled breath is compared to a pre-stored template within a comparator. This template represents a normal, unobstructed breath. At any time during inhalation, if the deviation of the breath from this template due to, for example, a cough, a sigh, a swallow, and a hiccup as determined by a test element exceeds a specified threshold (typically, 1 scale unit), the breath is rejected. For the data that has not been rejected, a moving average of the first such scaled point is calculated by a central controller 4230 for several preceding inspiratory events. This is repeated for a second such point over the same inspiratory event and thereafter. Thus, for example, 65 scaled data points are generated by the central controller 4230, indicating the moving average of several preceding inspiratory events (e.g., 3 events). Hereinafter in this specification, the moving average of the values of continuously updated (e.g., 65) points is referred to as "scaled flow rate" and is denoted by Qs(t). Alternatively, a single inspiratory event may be used instead of the moving average.

[0271] Two shape factors related to the determination of partial obstruction can be calculated from the scaled flow rate.

[0272] Shape factor 1 is the ratio of the average of the middle (e.g., 32) scaled flow rate points to the average of the overall (e.g., 65) scaled flow rate points. If this ratio is greater than 1, the breath is considered normal. If this ratio is less than 1, the breath is considered to have an obstruction. When the ratio is approximately 1.17, it is considered as the threshold between a partially obstructed and an unobstructed breath, equivalent to a level of obstruction that allows for the maintenance of appropriate oxygen supplementation in a typical patient.

[0273] Shape factor 2 is calculated as the mean square deviation from the flow rate scaled in units over an intermediate (e.g., 32) points. When the mean square deviation is about 0.2 units, it is considered normal. When the mean square deviation is zero, the respiration is considered overall flow-restricted. The closer the mean square deviation is to zero, the more the respiration is considered flow-restricted.

[0274] Shape factors 1 and 2 may be used alternatively or in combination. In other forms of the present technology, the number of sampled points, respiration, and intermediate points may be different from those described above. Further, the threshold value may also be different from that described above. 5.4.3.2.5 Determination of apnea and hypopnea

[0275] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea.

[0276] In one form, the apnea / hypopnea determination algorithm 4325 receives the respiratory flow signal Qr as an input and provides a flag indicating whether apnea or hypopnea has been detected as an output.

[0277] In one form, apnea is considered to be detected when the function of the respiratory flow Qr falls below a flow threshold over a predetermined period. This function may determine the peak flow rate, the average flow rate over a relatively short period, or the flow intermediate value of the average and peak flow rates over a relatively short period (e.g., RMS flow). The flow threshold may be a measurement of the flow rate over a relatively long period.

[0278] In one form, hypopnea is detected when a function of respiratory flow rate Qr falls below a second flow rate threshold over a predetermined period. This function may determine peak flow rate, relatively short-term average flow rate, or a flow rate intermediate value of relatively short-term average and peak flow rate (e.g., RMS flow rate). The second flow rate threshold may be a relatively long-term measurement of flow rate. The second flow rate threshold is higher than the flow rate threshold used for apnea detection. 5.4.3.2.6 Determination of snoring

[0279] In one form of the present technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the snoring range.

[0280] In one form, the snoring determination algorithm 4326 receives the respiratory flow signal Qr as an input and provides as an output a measurement of the range in which snoring is present.

[0281] The snoring determination algorithm 4326 may include the step of determining the intensity of the flow signal within the range of 30 to 300 Hz. Further, the snoring determination algorithm 4326 may include the step of filtering the respiratory flow signal Qr to reduce background noise (e.g., airflow sound in the system from the blower). 5.4.3.2.7 Determination of airway patency

[0282] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining the range of airway patency.

[0283] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as an input and determines the output of the signal within the frequency range of about 0.75 Hz to about 3 Hz. The presence of a peak within this frequency range is considered to indicate airway opening. The absence of a peak is considered to be a sign of airway closure.

[0284] In one form, the frequency range for which the peak is sought is the frequency range that is the frequency of the small forced oscillation at the therapeutic pressure Pt. In one embodiment, the forced oscillation is at a frequency of 2 Hz with an amplitude of about 1 cmH2O.

[0285] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as an input and determines the presence or absence of a cardiac generated signal. The absence of a cardiac generated signal is considered an indication of airway closure. 5.4.3.2.8 Determination of Target Ventilation

[0286] In one form of the present technology, the central controller 4230 takes the measurement of the current ventilation Vent as an input and executes one or more target ventilation determination algorithms 4328 for the determination of the target value Vtgt for the ventilation measurement.

[0287] In some forms of the present technology, the target ventilation determination algorithm 4328 does not exist and the target value Vtgt is predetermined and obtained, for example, by hard coding at the time of configuring the RPT device 4000 or by manual entry through the input device 4220.

[0288] In other forms of the present technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp indicative of the patient's typical recent ventilation.

[0289] In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a value that is a high percentage and less than the typical recent ventilation Vtyp. Such a high percentage for such forms can be within the range (80%, 100%), or (85%, 95%), or (87%, 92%).

[0290] In other forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a value slightly above a multiple of 1 of the typical recent ventilation Vtyp.

[0291] A typical recent ventilation Vtyp is a value around which measurements of the current ventilation Vent over a plurality of time instants over several predetermined time scales are distributed and tend to cluster (i.e., a measure of the central tendency of the measurements of the current ventilation in the recent history). In one embodiment of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case must be longer than the time scales of the chain - Stokes increment and decrement cycles. The target ventilation determination algorithm 4328 can determine a typical recent ventilation Vtyp from the measurements of the current ventilation Vent using any of a variety of well - known measures of central tendency. One such measure is the low - pass filter output for the measurements of the current ventilation Vent, with a time constant equal to 100 seconds. 5.4.3.2.9 Determination of treatment parameters

[0292] In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 for the determination of one or more treatment parameters using values returned from one or more of the other algorithms in the treatment engine module 4320.

[0293] In one form of the present technology, the treatment parameter is the instantaneous treatment pressure Pt. In one embodiment of this form, the treatment parameter determination algorithm 4329 determines the treatment pressure Pt using the following equation.

[0294]

Equation

[0295] where: A is the amplitude, Π(Φ,t) is the waveform template value (in the range from 0 to 1) at the current value Φ of the phase and at time t, P0 is the base pressure.

[0296] When the waveform determination algorithm 4322 provides a waveform template Π(Φ,t) as a look-up table of values Π indexed by the phase Φ, the treatment parameter determination algorithm 4329 locates the nearest look-up table input for the current value Φ of the phase returned from the phase determination algorithm 4321 or applies Equation (1) otherwise between two inputs straddling the current value Φ of the phase.

[0297] The values of the amplitude A and the base pressure P0 can be set by the treatment parameter determination algorithm 4329 according to the respiratory pressure treatment mode selected as follows. 5.4.3.3 Treatment control module

[0298] A treatment control module 4330 according to one aspect of the present technology receives, as inputs, treatment parameters from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 and controls a pressure generator so as to deliver an air flow from the pressure generator 4140 according to these treatment parameters.

[0299] In one form of the present technology, the treatment parameter is a treatment pressure Pt, and the treatment control module 4330 controls the pressure generator so as to deliver an air flow from the pressure generator 4140 such that the interface pressure Pm at the patient interface 3000 or 3800 is equal to the treatment pressure Pt. 5.4.3.4 Detection of failure states

[0300] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for the detection of failure states. The failure states detected by the one or more methods 4340 can include at least one of the following: Power outage (no power or insufficient power) Detection of converter failure Failure to detect the presence of a component Operating parameters are outside the recommended range (e.g., pressure, flow rate, temperature, PaO2) Failure to test warnings to generate detectable warning signals.

[0301] When a fault condition is detected, the corresponding algorithm 4340 signal signals the presence of the fault by one or more of the following: Initiation of audible, visual and / or kinetic (e.g., vibratory) warnings Message transmission to an external device Incident logging 5.5 Air circuit

[0302] An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that during use an air flow moves between two components (e.g., the RPT device 4000 and the patient interface 3000 or 3800).

[0303] Specifically, the air circuit 4170 can be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there may be separate legs of the circuit for inhalation and exhalation. In other cases, a single leg is used.

[0304] In some forms, the air circuit 4170 can include one or more heating elements configured to heat the air in the air circuit (e.g., for maintaining or increasing the air temperature). The heating element can take the form of a heating wire circuit and can include one or more transducers (e.g., temperature sensors). In one form, the heating wire circuit can be wound helically around the axis of the air circuit 4170. The heating element can communicate with a controller (e.g., the central controller 4230). An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349. The entire disclosure of this document is incorporated herein by reference. 5.5.1 Supplemental gas delivery

[0305] In one form of the technology, a replenishing gas, such as oxygen 4180, can be delivered to one or more points in the pneumatic path (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000 or 3800. 5.6 Humidifier 5.6.1 Overview of the Humidifier

[0306] In one form of the technology, a humidifier 5000 is provided for varying the absolute humidity of air or gas to be delivered to a patient relative to ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and the temperature of an air flow before it is delivered to a patient's airway.

[0307] The humidifier 5000 can include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering the humidified air flow. In some forms, such as shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 can be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 can further include a humidifier base 5006. The humidifier base 5006 can be adapted to receive the humidifier reservoir 5110 and can include a heating element 5240. 5.6.2 Humidifier Components 5.6.2.1 Water Reservoir

[0308] According to one arrangement configuration, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain amount of liquid (e.g., water) to be evaporated for humidifying the air flow. The water reservoir 5110 may be configured to contain a predetermined maximum amount of water to provide adequate humidification over at least the duration of a respiratory therapy session (e.g., an overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0309] According to one aspect, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 may be configured to facilitate the movement of the air flow along a serpentine path within the reservoir 5110 while the air flow is in contact with a certain amount of water within the reservoir 5110.

[0310] According to one form, the reservoir 5110 may be removable from the humidifier 5000 in the lateral direction, as shown, for example, in FIGS. 5A and 5B.

[0311] The reservoir 5110 may also be configured to inhibit the release of liquid from the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal orientation of operation (e.g., through any aperture and / or between its sub-components). Since the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent air pressure loss through leakage and / or flow impedance. 5.6.2.2 Conductive portion

[0312] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to enable efficient heat transfer from the heating element 5240 to a fixed amount of liquid in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, although other shapes may also be suitable. All or part of the conductive portion 5120 may be composed of a thermally conductive material such as aluminum (e.g., having a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, appropriate thermal conductivity may be achieved with a lower conductivity material of appropriate geometry. 5.6.2.3 Humidifier Reservoir Dock

[0313] In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 configured to receive the humidifier reservoir 5110 (as shown in FIG. 5B). In some arrangements, the humidifier reservoir dock 5130 may include a locking function (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130). 5.6.2.4 Water Level Indicator

[0314] The humidifier reservoir 5110 may include a water level indicator 5150 as shown in FIGS. 5A - 5B. In some forms, the water level indicator 5150 may provide one or more indications to a user such as the patient 1000 or caregiver regarding the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include notification of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)). 5.6.2.5 Humidifier Converter(s)

[0315] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the above-described transducer 4270. The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5C. The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., the central controller 4230 and / or the humidifier controller 5250). In some forms, the humidifier transducer may be disposed outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signal to the controller. 5.6.2.5.1 Pressure transducer

[0316] One or more pressure transducers 5212 may be provided to the humidifier 5000 in addition to or instead of the pressure sensor 4272 provided within the RPT device 4000. 5.6.2.5.2 Flow transducer

[0317] One or more flow transducers 5214 may be provided to the humidifier 5000 in addition to or instead of the flow sensor 4274 provided within the RPT device 4000. 5.6.2.5.3 Temperature transducer

[0318] 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 (e.g., the temperature of the heating element 5240 and / or the temperature downstream of the air flow at the humidifier outlet 5004). In some forms, the humidifier 5000 may further include a temperature sensor 5216 that detects the temperature of the ambient air. 5.6.2.5.4 Humidity transducer

[0319] In one form, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas such as ambient air. In some forms, the humidity sensor 5218 may be disposed towards the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor. 5.6.2.6 Heating element

[0320] In some cases, the heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more of the amount of water in the humidifier reservoir 5110 and / or the amount of water to the air flow. The heating element 5240 may include a heat generating component such as an electrical resistance heating track. One suitable example of the heating element 5240 is, for example, the layered heating element described in PCT Patent Application Publication No. WO2012 / 171072. The entire content of this document is incorporated herein by reference.

[0321] In some forms, the heating element 5240 may be provided into the humidifier base 5006. In the humidifier base 5006, heat may be sent to the humidifier reservoir 5110 mainly by conduction as shown in FIG. 5B. 5.6.2.7 Humidifier controller

[0322] According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250 as shown in FIG. 5C. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that can communicate with the central controller 4230.

[0323] In one form, the humidifier controller 5250 may receive measurements of characteristics (e.g., temperature, humidity, pressure, and / or flow rate) as inputs (e.g., measurements of air flow, water in the reservoir 5110 and / or in the humidifier 5000). The humidifier controller 5250 may also be configured to execute or implement a humidifier algorithm and / or deliver one or more output signals.

[0324] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240). 5.7 Fitting of a Patient Interface with a Guide 5.7.1 Overview of the Fitting with a Guide

[0325] When the patient interface 3000 is associated with a medical device, special knowledge may be required from (e.g., a physician or other medical professional) during setup and use. Further, even if the patient interface 3000 is initially properly set up, over time, adjustments that require special knowledge may be needed. However, when the patient sets up and adjusts the patient interface 3000, medical professionals are not always available. As such, the patient interface 3000 associated with a medical device may be used in the patient 1000's home. If the patient cannot properly set up or adjust the patient interface, it may lead to discomfort in the patient 1000, discontinuation of the use of the patient interface 3000, and / or a decrease in the effectiveness of the treatment being received.

[0326] Applications provided in various forms of the present technology guide the patient when the patient 1000 wears the patient interface 3000 associated with a medical device (e.g., the RPT device 4000), detect proper and / or improper positioning of the patient interface, and / or guide the patient to adjust the patient interface 3000 to the correct fitting position of the patient interface 3000.

[0327] Through the use of augmented reality, a patient can be connected to know-how regarding headgear size and fitting based on a diverse range of fitting range investigations performed on a diverse range of patients for the various components of the patient interface 3000 and / or components connected to the patient interface 3000. The large database obtained thereby can be tapped through a virtual / physical interface, thereby assisting in the fitting of the patient interface 3000 (through efficient headgear sizing and tightening without considering patient positioning).

[0328] As described in more detail below, the system (e.g., a camera system) provided by the above virtual solution performs the following: scanning the patient's face profile, capturing key points of the face structure as various data points, and transmitting the data to a data bank for analysis (e.g., using cloud technology).

[0329] This virtual solution enables the determination of key data points on the patient's face structure using existing databases (e.g., from mask and / or headgear selection tools of manufacturers, distributors, and / or clinicians). The patient's face structure can be cross-referenced with one or more predetermined components of the patient interface 3000 (e.g., the type and / or length of the headgear strap) for the calculation of desired component settings (e.g., the length and tightening of headgear adjustment). Data can be provided to the patient's device (e.g., a mobile device and / or the RPT device 4000) for instructing the patient in the creation of the determined component settings (e.g., indicating the amount of tightening required on the headgear for achieving a good fit of the mask system).

[0330] The fitting of the headgear can be achieved, for example, through one or more of the following options: one or more physical markings on the headgear for manual positioning; physical markers on the headgear for determining one or more stretch marks that vary to indicate stretch force; and / or the use of current facial measurements (for determining the length for the stretch and fit of the headgear), an overlay on the patient's facial structure of the estimated tightening, and / or the provision of visual and auditory cues when the patient reaches the estimated headgear adjustment amount.

[0331] In some examples, to ensure the achievement of an appropriate seal, the virtual solution described above can be integrated via a defined flow generator and communication technology (e.g., Bluetooth® or WiFi®) for determining leakage during treatment.

[0332] According to an example of the present technology, one or more limitations in conventional approaches to patient interface selection, fitting, and / or adjustment are eliminated. For example, in the case of a conventional approach, the user guide is provided in printed form, so it may be difficult for some patients to understand from photos and words. Also, the patient may need to travel to the clinician's office for mask fitting, or the clinician may need to travel to position the patient. In such cases, for the patient, it may be necessary to make an appointment, which can be a time-consuming task (e.g., it may take several days to several weeks for a reservation in some cases), and visit the office to receive instructions, increasing time and effort.

[0333] In addition, even after the first fitting session is received with the assistance of a clinician, the patient will mimic the above fitting at home. If there is a change in the fitting of the headgear or the patient forgets how to mimic the adjustment (e.g., after cleaning), the patient may have to make a separate appointment or figure it out on their own, which can lead to improper fitting of the mask system and a decrease in treatment effectiveness. Improving the ease of use of the mask system / headgear can also lead to improved compliance and support for patient treatment continuation.

[0334] In addition, if there is a change in the patient's facial profile (e.g., due to weight gain or loss), it becomes necessary to appropriately change the fitting of the headgear. If the patient is unable to adjust the fitting themselves, the patient will need to have the order for mask refitting updated (e.g., by revisiting the clinician's office).

[0335] The video and virtual solutions provided by examples of the present technology are easily accessible to the patient from home, streamline the mask fitting process, and enable the patient to initiate treatment more quickly than conventional solutions. 5.7.1.1 Guided fitting of the patient interface based on an established baseline

[0336] According to one aspect of the present technology, the fitting of the patient interface is performed based on a baseline. The establishment of the baseline can be done by the manufacturer, clinician, and / or by the patient at the first use of the patient interface 3000 and / or during the use of the patient interface 3000. The baseline can define the proper positioning of the patient interface 3000 on the patient's face. The establishment of the baseline can be performed based on one or more images and / or videos of the patient interface on a person's face (which can be the patient's face in some examples). The images can be obtained from a database and captured at the first use and / or after the use of the patient interface 3000.

[0337] FIG. 6A shows the fitting of an exemplary patient interface 3000 based on a baseline according to one aspect of the present technology. Patient 1000 wearing the patient interface 3000 can properly position the patient interface 3000 on the patient's face using a local external device 4288 (e.g., a personal computer, mobile phone, tablet, and / or remote control) that includes a camera 630, a display device 616, and an input device 612. Although the example refers to the local external device 4288, in some aspects of the present technology, one or more operations can be performed by an RPT device 4000 that includes a camera 630, a display device 616, and / or an input device 612.

[0338] As shown in FIG. 6A, the processing system of the local external device 4288 can be configured to capture one or more images of patient 1000 and the patient interface 3000 (step 6910), compare these images with the baseline (step 6912), and display the results (step 6914).

[0339] These images can be captured after positioning of the patient interface 3000 on the face by the patient, and an input from the capture of the image by the patient is received via the input device 612. Multiple images can be captured. In some examples, a video including a series of images can be captured. The local external device 4288 can guide the capture of the image by the patient such that the image capture is performed from different positions and / or orientations (so as to capture the entire profile of the patient's head and the patient interface 3000).

[0340] As shown in FIG. 6A, when controlling the forward-facing camera 630 provided on the same side as the display device 616 to capture an image, the display device 616 can guide the user to position the camera for the next image. This image capture application can be configured to automatically capture a series of images while the camera is being moved around the patient's head. In some examples, the infrared (IR) sensing imaging sensor that may be included in the camera 630 can be configured to perform including a filter that enables the capture of IR images and / or enables the camera 630 to capture IR images (in addition to and / or instead of the normal image of visible light). In some examples, the local external device 4288 can include an IR emitter 632 configured to send an IR signal that can be detected by the camera 630.

[0341] The captured image can be compared with data defining a baseline to determine where the positioning and / or settings of the patient interface 3000 differ from the baseline. This baseline can be defined by one or more images of the patient interface 3000 on a patient's head or another person's head and / or other parameters. In some examples, the captured image can be used for generating a profile of the patient and / or the patient interface (e.g., a three-dimensional profile), and the generated profile can be compared with a baseline profile. The positioning and / or orientation of the camera can be measured by sensors (e.g., accelerometers) within the device (when each image is captured) and can be used in generating the profile.

[0342] In some examples, the data defining the baseline can include parameters associated with the patient interface 3000. These parameters can be assigned to the type (e.g., model and configuration) of the patient interface 3000 used by the patient and / or patient 1000, and these parameters can be used to determine whether the patient interface 3000 in the captured image is worn in the manner defined by the baseline. For example, these parameters can define the spacing and / or positioning of different components of the patient interface 3000 relative to each other and / or the relationship of different components of the patient interface 3000 to the patient's face features (e.g., eyes, nose, etc.). These parameters can be compared with corresponding data extracted from the captured image.

[0343] Comparing these images to a baseline may involve performing image analysis to detect features in the images. The detected features may include features and / or edges of the patient interface 3000, symbols and / or marks and / or face features on the patient interface 3000. Image analysis may include applying one or more filters (e.g., edge detection and feature extraction) to the captured images. The detected features may be counted and / or compared to the positions of other features and / or marks. In some examples, the detected features may include one or more face features shown in FIGS. 2B - 2F.

[0344] Based on the comparison, the local external device 4288 may display the results of the comparison and / or provide instructions to modify the positioning and / or settings of the patient interface 3000. The settings of the patient interface 3000 may include the length of the tubes and / or straps of the positioning and stabilization structure 3300. These results may indicate that one or more problems exist and may provide options for correcting each of these problems. These results may be provided with text and / or images identifying the problems. These results may include instructions provided with text, images, and / or video explaining and / or presenting how to correct the identified problems.

[0345] In some examples, the results may include super - imposing the patient interface 3000 in the correct position and / or settings on the captured image(s). The results may include an animation including a series of images showing the superimposed patient interface 3000 moving from its position in the captured image to the correct position.

[0346] In some examples, the analysis may include detecting components that are missing or damaged in the patient interface 3000 and displaying results indicating how to replace such components. The displayed results may provide an option to order the missing or damaged components. For example, in the analysis, it may be determined that the ventilation part on the mask is missing, and the patient may be provided with an option to order the missing ventilation part. 5.7.2 Communication with Remote Computer Systems

[0347] FIG. 6B shows a diagram of a communication system for data transmission between an RPT device 4000, a local external computing device 4288, and a remote external device 4286, according to one embodiment of the present technology. FIG. 6B includes an RPT device 4000 associated with a patient 1000. The present technology is not limited to RPT devices and may be applied to other medical devices as well.

[0348] The RPT device 4000 can be configured to communicate with a remote external device 4286 and / or a local external device 4288 (e.g., a personal computer, a mobile phone, a tablet, and / or a remote control) via a data communication interface 4280. The local external device 4288 may be configured to communicate directly with the RPT device 4000 (when located in the vicinity of the RPT device 4000), or alternatively, may be configured to communicate remotely via a local or external network (when the local external device 4288 is not located in the vicinity of the RPT device 4000). The remote external device 4286 may be accessible by appropriately authorized persons (e.g., clinicians, manufacturers, and / or device suppliers). The remote external device 4286 may include a server and / or a cloud computing platform (e.g., Amazon Web Services (R), Google (R) Cloud Platform, Microsoft (R) Azure). The remote external device 4286 may include applications executable by the RPT device 4000 and / or the local external device 4288 for controlling the operation of the RPT device 4000. The remote external device 4286 may include instructions regarding the use of the RPT device 4000 and / or the patient interface 3000, and applications for troubleshooting the operation and / or use of the RPT device 4000 and / or the patient interface 3000.

[0349] One or more other medical devices 6062 or 6064 (which may be RPT devices) may be associated with other patients 1002 and 1004 and may be configured to communicate with the remote external device 4286, the server 6030, and / or the cloud computing platform 6040.

[0350] The device shown in FIG. 6A may communicate via a communication link 6020 that includes a remote external communication network 4282 and / or a local external communication network 4284.

[0351] The RPT device 4000, the medical devices 6062 and 6064, and the local external computing device 4288 may be configured to receive data from the remote external device 4286 and to transmit data including sensor data, feedback, images, and / or video via the communication link 6020 to the remote external device 4286. The remote external device 4286 may be configured to generate a database to assist in guiding a patient during fitting of the patient interface 3000. This database may include baseline information associated with a particular patient interface and / or multiple patients. In some examples, the server and / or cloud computing platform of the remote external device 4286 may receive patient data (e.g., age range, gender, weight, environment, face profile, patient interface type, RPT device type) and may classify the data. The received information may include captured images of the patient and the patient interface when there is a proper fit, and images of the patient and the patient interface when the patient indicates that there is a problem with the fit.

[0352] The remote external device 4286 can segment the received data for model generation and can be used to guide the user during the initial setup of the patient interface 3000 when the user experiences problems related to the patient interface 3000 and / or (e.g., after a change in the patient's facial profile and / or after a change in the settings of the patient interface 3000) when the user needs readjustment of the patient interface 3000. These models can be used as a baseline for detecting improper mask fitting (e.g., based on photos and / or videos of the patient). These models can be pre-specified by advanced analytics, artificial intelligence, and / or machine learning. The remote external device 4286 can include models determined based on information received from the user (e.g., historical information) during the previous use of the same or different patient interfaces 3000, information from other users (e.g., users associated with the medical devices 6062 and 6064), and / or information input by the manufacturer and / or clinician. Advanced analytics, artificial intelligence, and / or machine learning can be performed on data from a large number of patients, and these models can be updated with new data (e.g., data including demographics, feedback, images, videos, and / or changes to compliance) when the new data becomes available. The analysis results can include individually adjusted instructions generated based on information received from other medical devices 6062 and 6064, the manufacturer, and / or the clinician. When additional information is received from other medical devices 6062 and 6064, the manufacturer, and / or the clinician, the advanced analytics can change the baseline and / or solution for the detected problem.

[0353] In some examples, different baselines can be determined and stored for each user and / or patient interface. Because the database can include corresponding settings (e.g., the degree of tightening by the strap) from different masks and / or headgears, when a user migrates from using one mask and / or headgear to another mask and / or headgear, the correct settings can be provided to the user.

[0354] In some examples, the remote external device 4286 can perform analysis and / or determine instructions for display to the patient. In this example, the remote external device 4286 can receive captured images of the patient and the patient interface 3000 and can perform analysis for determining problems associated with the patient interface 3000. Based on the analysis, information / instructions to be displayed to the patient for correcting the identified problems are determined and the information / instructions are transmitted to the RPT device 4000 and / or the local external computing device 4288. 5.7.3 Method for Establishing a Baseline and Using the Baseline

[0355] FIG. 6C shows an example of a guided fitting of a patient interface based on a baseline associated with the patient interface 3000 at setup, according to one form of the present technology. One or more operations shown in FIG. 6C can be performed by an application executed on the RPT device 4000 and / or an application executed on a local external device (e.g., a personal computer, a mobile phone, a tablet, and / or a remote control) used by the patient. In some examples, one or more operations can be performed by an application executed on the remote external device 4286.

[0356] The application may enable the user interface to receive patient information and / or one or more images (step 7012). This received patient information may include patient demographic information (e.g., age, gender, weight, environment, face profile information, sleep position, and / or type of RPT device). These one or more images may be captured by a camera including the RPT device 4000 or a local external device. In step 7012, one or more images may be captured by the camera for obtaining the patient's face profile. In some examples, through the analysis of one or more images, key points of the face structure may be determined as various data points.

[0357] In step 7014, the patient interface 3000 to be used is selected. The selection of the patient interface 3000 may be made based on the input received from the patient. In some examples, the user may input the model of the patient interface 3000, select a specific configuration of the patient interface 3000, and / or capture an image of the patient interface 3000. In some examples, the image of the patient interface 3000 may include the patient interface packaging or the code provided on the patient interface 3000. This code is used to identify the patient interface 3000 and / or the configuration of the patient interface 3000. The configuration of the patient interface 3000 may identify the type and / or size of the stabilization structure 3300 and / or the seal formation structure 3100 (e.g., nasal cushion and / or oronasal cushion) used by the patient.

[0358] In some examples, the patient interface 3000 used can be automatically selected by the application based on the captured images of the patient. The mask fitting and selection systems and methods disclosed in U.S. Patent No. 7,827,038 and / or U.S. Patent No. 8,254,637 (each of which is incorporated herein by reference in its entirety) can be used to determine a mask suitable for the patient.

[0359] These captured images can provide one or more different views of the patient's face. The application can generate a three-dimensional profile of the patient's face based on the captured images. In some examples, the application can obtain a recommendation for a particular patient interface 3000 based on the three-dimensional profile. The three-dimensional profile can identify the relative positioning and / or size of facial features (e.g., eyes, nose, mouth, ears, upper lip, and lower lip). In some examples, the three-dimensional profile can identify the relative positioning of one or more of the features shown in FIGS. 2B-2F.

[0360] The recommendation for the patient interface 3000 can be made based on the features identified in the three-dimensional profile and / or based on the patient's demographic information. The recommendation for the patient interface 3000 can select the type and / or size of the stabilization structure 3300 and / or the seal-forming structure 3100 that provides the most effective and efficient seal. The type of the stabilization structure 3300 and / or the seal-forming structure 3100 can identify the material type, texture, and / or color of the stabilization structure 3300 and / or the seal-forming structure 3100. Comfort and seal effectiveness can be determined based on a local or remote database of previously matched patient profiles and patient interface configurations.

[0361] In some instances, the application may generate an image or video along with a recommended patient interface or a patient-selected patient interface super-imposed on the captured image. The application may be configured to provide a real-time augmented reality display of the recommended or selected patient interface super-imposed on a captured image of the patient's face. The application may provide the patient with the option to save and / or share the generated image (e.g., on social media).

[0362] The application may display to the patient an instruction to "use the patient interface" (step 7016). These instructions may include an instruction to configure the RPT device 4000 for use with the selected patient interface 3000, how to connect the RPT device 4000 of the patient interface 3000, how to position the patient interface 3000 on the patient's face, and / or an instruction to adjust the settings of the patient interface 3000. These instructions may be generated based on a captured image (e.g., the patient's face profile) by the application and / or the remote processing system. For example, the instruction may direct the patient regarding the settings for one or more straps of the headgear determined based on the patient's profile.

[0363] In step 7018, an image including the patient with the patient interface 3000 may be captured. These captured images may be used when the patient establishes a baseline using the selected patient interface 3000.

[0364] These images can be captured after the patient positions the patient interface 3000 on the face, and a confirmation notification that a comfortable fit has been obtained with the patient interface 3000 is received from the patient and / or a confirmation notification indicating that the patient interface 3000 is operating properly (e.g., no leak detection during operation of the RPT device 4000) is received from the patient or the application.

[0365] In step 7020, a determination is made as to whether the patient has a problem with the patient interface. This determination can be made based on input received from the patient via the user interface. In some examples, the determination can be made automatically based on data indicating the presence or absence of a leak within the patient interface 3000. This data is sent from sensors disposed within the RPT device 4000 and / or the air circuit 4170. In some examples, the application can display a request to the patient to notify whether the patient has a problem with the patient interface 3000 based on the use of the patient interface (e.g., if the use of the RPT device 4000 is not as prescribed for the patient).

[0366] If a signal is received that the patient is experiencing a problem with the patient interface (yes in step 7020), images of the patient and the patient interface can be captured (step 7022). The images can be captured from a plurality of different positions and orientations. In some examples, if a signal is received that the patient is experiencing a problem with the patient interface (yes in step 7020), the patient can be requested to identify the discomfort or source of the problem (by providing an image, an audible command, and / or a text input).

[0367] By analyzing the captured image (step 7024), the source of discomfort or the ineffectiveness of the supply of breathable gas (e.g., leakage of breathable gas) can be determined. The captured image can be compared with a baseline (which may include the image captured in step 7018 or the image stored in the database).

[0368] The analysis can include detecting features of the patient interface 3000 that may be the source of discomfort or the ineffectiveness of the supply of breathable gas. For example, the image can be analyzed to identify the position of the straps of the headgear that may be the cause of discomfort. If the straps are overly stressed or loose, they can cause discomfort and can be detected by a change in the color of the straps (due to excessive tightening or lack of tightening). In some examples, the distance between markers arranged along the length of the strap whose relative position changes with the tightening of the strap can be detected and used to identify straps that are overly tightened or insufficiently tightened. These markers may be visible to the patient or may be invisible to the patient (e.g., without a camera). Markers that are invisible to the patient can be detected after performing image analysis (for extraction of markers from the captured image and / or markers captured by a special camera or camera setting (e.g., use of an infrared camera)).

[0369] In some examples, the camera may detect areas on the patient's face where excessive pressure is being exerted on the patient's face due to the straps and / or seal-forming structures, based on differences in the color or temperature distribution of the patient's skin. Analysis of the images from the camera can determine heat zones on the patient due to excessive pressure from the patient interface. In other examples, the heat distribution along the patient interface 3000 can be used to determine portions of the patient interface 3000 that are not in contact with the patient. Portions of the patient interface 3000 that are not in contact with the patient may appear as cooler in the IR image (compared to portions of the patient interface 3000 that are in contact with the patient's face). In some examples, analysis of stretch marks on the patient interface (e.g., straps and / or mask cushions) can determine the level of stretch within a particular portion of the patient interface (e.g., determine that the particular portion is overly stretched and / or more stretched than other portions of the patient interface).

[0370] In some examples, the analysis can include comparing a baseline image with a captured image of the patient that includes the patient interface 3000 (when the patient is experiencing an issue). In this example, comparison of the images can determine changes in the positioning relative to one or more features of the patient's face of the patient interface 3000 and changes in the relative positioning of one feature of the patient interface (e.g., a first strap) to another feature of the patient interface (e.g., a second strap). Prior to comparison of the images, processing for analysis improvement (e.g., scaling, background removal) can be performed on the captured image. Scaling of the captured image can be performed such that the size of the patient's features in the captured image corresponds to the patient's features in the baseline image.

[0371] In some examples, the analysis performs an analysis of the received audio and / or text (with or without an analysis of the image) to determine the source of discomfort or the ineffectiveness of the breathable gas supply and to provide a solution to the identified problem. In other examples, the analysis may include leakage detection data obtained from sensors to provide adjustment feedback for improving the fit.

[0372] The analysis results may be displayed by the application (step 7026). The analysis results may include advice to the user on how to correct the problem identified using the patient interface 3000. The analysis results may include identifying the difference in the positioning of the patient interface 3000 between the baseline image and the captured image. The application may display an instruction to correct the position of the patient interface 3000 so that the patient interface 3000 is provided at a position provided within the baseline image. For example, the displayed instruction may include text, an image, and / or an animation showing how to adjust the length of the strap on one side of the face so that the pressure from the strap onto the seal-forming structure on that side is approximately equal to the pressure added from the other side of the seal-forming structure (from the strap on the other side of the face).

[0373] The displayed analysis results may include displaying the captured image and one or more indicators showing positions where the patient interface can be adjusted (for improving comfort and / or fit). These indicators may include text, symbols, shading, and / or the outline of the patient interface edge indicating the position of the source of the problem. These indicators may be selectable by the user to provide more information about the identified problem. The indicators may include multiple numerical notifications about the adjustable positions of the patient interface, and these numbers may be ordered based on the predicted level of improvement in comfort and / or fit.

[0374] After it is determined that there are no problems with the patient interface (No in step 7020), the program may proceed to a resolved state (step 7030). The resolved state may be maintained until one or more of the following occur: The user indicates that they are experiencing problems with the patient interface, A determination is made that a new patient interface is being used (e.g., based on detection of connection of the new patient interface to the RPT device 4000), Data from one or more of the sensors indicates that the positioning of the patient interface 3000 is inaccurate, A predetermined length of time has elapsed since the resolved state, After the resolved state, after the RPT device 4000 has been used for a predetermined length of time, or After the resolved state, after the RPT device 4000 has been used a predetermined number of times.

[0375] After execution of the program through steps 7022, 7024, and 7026, in step 7010, a determination may be made again as to whether the patient is experiencing no new / additional problems with the patient interface (step 7020). After adjustment of the positioning of the patient interface, steps 7022, 7024, and 7026 may be repeated until the user is satisfied with the comfort and effectiveness of the patient interface 3000.

[0376] As noted above, in some examples of the present technique, the determination of whether a patient has an issue with the patient interface can be made automatically based on data received from one or more sensors (e.g., transducers). The data from the sensors can also be used to perform an analysis (step 7024) and / or to provide recommendations to the patient in step 7026. The sensors can be disposed within the RPT device 4000 and / or the air circuit 4170 and indicate whether there is a leak in the patient interface 3000 and / or whether the positioning of the patient interface 3000 is inaccurate. The determination of issues regarding the use of the patient interface 300 (steps 7020 and / or 7024) and / or the display of the analysis results (step 7026) based on the sensor data may be performed in conjunction with the image analysis or, alternatively, as an alternative to the analysis performed based on the image.

[0377] The output from one or more sensors can be used as input data for determining issues related to the mask and for providing recommendations for correcting the issues. As shown in FIG. 7A, the sensor 4270 (e.g., a transducer) can be disposed on the surface or inside of the mask (e.g., the mouth cushion and / or nose cushion of the mask) and / or the stabilization structure 3300 (e.g., one or more of the straps 3330 and / or 3340 and / or the tubes 3310 and 3320). The sensor 4270 can include one or more of a flow sensor, a pressure sensor, a temperature sensor, a piezoelectric sensor, a motion sensor, a position sensor, and / or a strain gauge. In some examples, the sensor 4270 can detect proper connections between different components of the patient interface. In one example, the strain gauge can be provided on the surface or inside of the headgear and / or cushion of the patient interface 3000 and can be configured to sense the tension within the portion of the headgear and / or cushion. The provision of data from the sensor 4270 to the processor can be performed wirelessly and / or via a wired connection.

[0378] Using the output from the sensor, changes in the positioning and / or characteristics of the mask and / or headgear arrangement can be detected in real time as the patient adjusts the setup in accordance with the instructions (e.g., the display screens 206 and 208 shown in FIG. 8B). The data from the sensor can be compared to preset values stored in memory (e.g., determined by the manufacturer or clinician), or can be received from the sensor when the patient has established a baseline with a mask / headgear that provides an appropriate fit (e.g., step 7018 in FIG. 6C). During the execution of steps 7020 to 7026, sensor data can be received and compared to the preset values. The analysis results (step 7026) can be displayed based on the comparison results and updated in real time as the patient adjusts the patient interface.

[0379] In some examples, sensor data can be received periodically to determine whether problems related to the use of the patient interface have been detected. For example, the receipt of sensor data can occur when the patient connects the patient interface to the RPT device 4000 and / or after a predetermined length of time after the start of the treatment cycle.

[0380] In some examples, one or more operations (e.g., the operations in FIG. 6C) can be performed continuously over a predetermined period. For example, operations 7016 and 7018 in FIG. 6C can be performed continuously in real time over a predetermined period to assist the patient with fitting the patient interface. In this example, the application can capture a plurality of images that can be captured in the form of video until the patient interface is properly positioned on the patient, determine an appropriate fit (e.g., the required settings) of the patient interface selected for the patient based on the patient's facial structure, and guide the patient towards providing an appropriate fit.

[0381] In an example of providing a setting for headgear strap length, a patient's facial structure is cross-referenced for a predetermined headgear strap length such that the length and tightening of the headgear for the patient can be calculated. Data for this determination may be stored during the application or at a remote location. In some examples, information about the patient's demographics, images, and / or the patient's face profile may be sent to a remote processing system (e.g., remote external device 4286) for analysis execution, and the application may receive the analysis results from the remote processing system.

[0382] By analyzing an image of the patient captured in operation 7018, it can be determined whether the current settings of the patient interface correspond to the length and tightening of the headgear determined for the patient. In operation 7016, instructions are displayed to instruct the patient to make adjustments necessary to achieve the length and tightening of the headgear determined for the patient. These instructions may include an overlay of the estimated tightening on the patient's facial structure and may provide visual and auditory cues when the patient reaches the estimated amount of headgear adjustment. These instructions may include visual and / or auditory indicators when the estimated amount of headgear adjustment is achieved. 5.7.4 Patient Interface Using Indicators and Reference Points

[0383] Figure 7A shows a patient interface 3000 including a plurality of measurable indicators 3350 and reference points, according to one embodiment of the present technology. The positioning and stabilization structure 3300 of the patient interface 3000 shown in Figure 7A includes tubes 3310 and 3320 provided as part of the positioning and stabilization structure 3300. These tubes provide a path for breathable air between the connection port 3600 and the seal-forming structure 3100. The positioning and stabilization structure 3300 includes a first strap 3330 and a second strap 3340. The end of the first strap 3330 is removably coupled to the seal-forming structure 3100, and the end of the second strap 3340 is removably coupled to the tubes 3310 and 3320.

[0384] Positioning on a particular patient interface 3000 can be obtained by the measurable indicator 3350 and / or reference point 3360, which can be compared to a baseline for determining whether the patient is properly wearing the patient interface. Use of the measurable indicator 3350 and / or reference point 3360 can lead to a reduction in the computational effort associated with the use of image processing for detecting more complex features of the patient interface 3000. The measurable indicator 3350 and / or reference point 3360 may not be visible to humans but may be detectable by a camera (e.g., an IR camera).

[0385] As shown in FIG. 7A, reference points 3360 are provided at different components and positions of the patient interface 3000. Tubes 3310 and 3320 include reference points 3360 provided on the outer surface and side surface. The reference points 3360 may be provided in the vicinity of the ends of the tubes and within the intermediate sections of the tubes. The nose and mouth cushion including the seal forming structure 3100, straps 3340 and 3330 and / or connection port 3600 may also include one or more reference points 3360. One or more reference points 3360 may indicate the center of a component (e.g., the nose and mouth cushion in the vertical and / or horizontal directions). These reference points are not limited to the positions shown in FIG. 7A and may be provided at other positions (e.g., on the straps and / or connection port 3600).

[0386] As shown in FIG. 7A, reference marker 3362 may be provided on a connector (e.g., a magnetic clip) used to connect the headgear strap to the nose and mouth cushion or nose cushion. From the shape that may be included in the reference marker 3362, the positioning and / or orientation of the patient interface 3000 and / or a part of the patient interface may be determined. The positioning and / or shape of the reference marker 3362 is not limited to the position and shape shown in FIG. 7A. One or more reference markers having the same and / or different shapes may be provided at other positions on the mask and / or headgear.

[0387] As shown in FIG. 7A, the first strap and the second strap include indicators 3350 that can be used to determine the setting of the strap (e.g., how far to stretch the strap). If the distance between the indicators 3350 on one side of the strap is greater than the distance on the other side of the strap, one side of the strap may be over-tightened or the tightening may be insufficient. Counting the number of visible indicators 3350 may indicate the setting at which the strap should be positioned during use.

[0388] FIG. 7B shows measurable indicators 3350 and / or reference points 3360 extracted from a captured image of a patient and a patient interface. A difference can be determined by comparing the extracted measurable indicators 3350 and / or reference points 3360 with the measurable indicators 3350 and / or baseline reference points 3360. As described above, by counting the number of extracted indicators 3350 and comparing the number with the number in the baseline, it can be shown whether the strap is too tight or insufficiently tightened.

[0389] The difference in distance between a particular extracted reference point 3360 and the corresponding reference point of the baseline can indicate whether there is an appropriate connection between components of the patient interface 3000 or whether adjustment of the patient interface 3000 is necessary. For example, if the distance D1 between two reference points has increased from the distance at the baseline, it can be determined that there is no appropriate connection between the nose and mouth mask and the tube 3320 connecting to the nose and mouth mask. As another example, if the distance D2 between two reference points has increased from the distance at the baseline, it can be determined that the length of the tube 3320 is too long and needs to be reduced. If the distance D3 between two reference points is different from the corresponding distance at the baseline, it can be determined that adjustment of the length of the tube 3320 (by extension or contraction of the expandable portion 3302 of the tube 3320) is necessary.

[0390] According to one aspect of the present technology, the extracted reference points 3360 can be used to construct a three-dimensional profile of the patient interface (such as shown in FIG. 7B), and the measurements can be compared with the three-dimensional profile of the patient interface provided at the baseline. In this example, by comparing the angles between the lines connecting the reference points, the distances of the lines connecting the reference points, the presence of parallel lines and / or the presence of perpendicular lines with the baseline, changes in the positioning and configuration of the patient interface 3000 can be determined.

[0391] Although not shown in FIG. 7B, patient features (e.g., one or more features shown in FIGS. 2B-2F) may be extracted, and in that case, those patient features can be used as part of the analysis for determining changes in the positioning of patient interface 3000. For example, the analysis may include determining changes in the distance between a person's eye and a reference point on the tube.

[0392] In some examples, problems related to the positioning of patient interface 3000 can be determined without using a baseline and / or patient features. For example, by comparing measurements from an extracted reference point on one side of the patient's head with corresponding measurements from an extracted reference point on the opposite side of the patient's head, it becomes possible to determine problems with the positioning of patient interface 3000 without a baseline. In this example, one side of the patient interface can be used as a reference when comparing with the other side of the patient interface.

[0393] Figures 7C and 7D show an example of a headgear strap 3002 that is part of a patient interface 3000 that can be adjusted based on an example of the present technology. FIG. 7C is a side view of the strap 3002, and FIG. 7D is a top view of the strap 3002. As shown in FIGS. 7C and 7D, a portion of the strap 3002 can be overlaid on another portion of the strap 3002 and removably connected to the overlay portion by a connector 3004 (e.g., a hook tab). The strap 3002 can include a plurality of indicators 3006. These plurality of indicators 3006 can include numerical values, characters, and / or symbols. When the strap 3002 is adjusted in the traction direction, the strap 3002 is further subdivided, so that the corresponding indicator can be made visible in the top view shown in FIG. 7D. The system can provide an indication to the user as to how far the strap should be pulled based on the indicator 3006. For example, the system can instruct the user to adjust the strap 3002 such that the indicator "3" becomes visible on the strap. In some examples, the system can determine details of the current setting of the strap 3002 by analyzing a captured image of the strap 3002, and if the setting does not correspond to the setting required for the strap 3002 determined for the patient, the system can instruct the patient to further adjust the strap 3002.

[0394] As described above, according to some examples of the present technology, an indicator (e.g., indicator 3350 in FIG. 7A) can be provided for determining a setting of the strap (e.g., how far to extend the strap). FIGS. 7E and 7F show an example of the spacing between indicators 3350 on the strap 3002 for determining the stretching force according to an example of the present technology. FIG. 7E is a top view and a side view of the strap 3002 in a non-stretched state. FIG. 7F is a top view of the strap 3002 in a stretched state. In some examples, the indicators 3350 provided in different portions of the patient interface 3000 can be provided at the same predetermined spacing in the non-stretched state.

[0395] As shown in FIGS. 7E and 7F, the distance D1 between consecutive indicators 3350 within the unstretched strap 3002 is less than the distance D2 between consecutive indicators 3350 within the stretched strap 3002. The system analyzes the captured images of the indicators 3350, compares the forces applied from different straps of the patient interface 3000 based on the distances between consecutive indicators 3350, determines whether the forces applied from the straps are within a predetermined upper and / or lower limit, and can determine whether the forces applied from the straps correspond to a setting determined for the patient. In some examples, the system monitors the change in the distance between consecutive indicators 3350 based on the captured images and can provide an auditory cue and / or a visual cue when the distance corresponds to the required setting.

[0396] Since the distance between consecutive indicators 3350 can vary across the length of the strap, the system can be configured to determine how much the strap is stretched (based on multiple distances between consecutive indicators 3350). The system can determine the average of the multiple distances for the determination of how much the strap is stretched. 5.7.4.1 Exemplary display screen for guiding the fitting of the patient interface

[0397] Figure 8A includes a series of display screens that assist a user in setting up a mask (patient interface) and capturing a baseline of the set-up mask. These display screens can be shown on the display of the local external device 4288 and / or the RPT device 4000. Some of the display screens shown in Figure 8A include instructions and show a mask with specific features, but examples of the present technology are not limited to this. One or more instructions and / or display screens may not be shown, and / or display screens may be added depending on other instructions and / or the type of mask the patient is using. For example, not all patient interfaces include the magnets, full-face masks, and / or lower straps shown in Figure 8A.

[0398] In certain examples, the nature of specific display screens can be generated based on the type of mask or patient interface the patient is using. The determination of the type of patient interface can be made based on the user specifying the mask, recognition of a barcode attached to the mask, use of image recognition, RFID, or other techniques for identifying the type of patient interface that is set up. In certain examples, the content of the relevant information, or the display screens to be generated and presented, can be based on such recognition. In certain examples, the order of the display screens and the content of the instruction information presented to the user can be based on the information recognized.

[0399] Display screen 120 is presented to the patient to take the mask out of the box in which the mask is packaged. In certain examples, an image, video, or animation showing how to take the mask out of the box can be shown to the patient. In certain examples, the patient interface can be transported while wrapped in its packaging material. Thus, for example, display screen 120 indicates that the patient needs to take the mask out of a support shell (e.g., something that can be provided around the mask among the packaging materials). In certain examples, an image, video, or animation showing how to remove the support shell or other packaging material can be shown to the patient.

[0400] The wearing method of the mask is instructed to the patient by display screens 122 and 124. The screen 124 can be used, for example, with a mask including a magnetic headgear connection part. Another screen can be used with a mask using a different headgear (for example, a headgear using snap connection, Velcro (registered trademark), elastic band, etc.). In the described example, the screen 124 instructs the patient to remove the magnet on the lower strap of the mask to release the headgear and position the mask appropriately. In a specific example, an image, video or animation showing how to remove the magnet can be displayed to the patient.

[0401] The patient is instructed to wear the mask by the display screen 126. In a specific example, an image, video or animation showing the wearing method of the mask can be displayed to the patient.

[0402] The patient is instructed to confirm that the mask and the headgear fit properly by the display screen 128. In a specific example, an image, video or animation showing how to properly fit the mask and / or the headgear to the patient's face can be displayed to the patient.

[0403] The patient is instructed to adjust the upper strap and the lower strap by the display screen 130. In a specific example, an image, video or animation showing the adjustment of the upper strap and / or the lower strap of the mask can be displayed to the patient. In a specific example, the upper strap and the lower strap need to fit snugly (without over-tightening) on the patient's face. This display screen and the display screen 130 can facilitate the patient to correctly adjust the strap (to avoid over-tightening or insufficient tightening of the strap).

[0404] The display screen 132 instructs the patient with additional information regarding the adjustment of the upper strap and / or lower strap of the mask. Specifically, the display screen 132 may indicate that it is necessary to keep the cushion portion of the mask in contact with the patient's face even when pulling the mask from the front.

[0405] In another step for the patient interface in the setup process, there is included a display screen 134 that instructs the patient to interconnect one or more tubes or conduits, and a display screen 136 that shows a patient wearing the mask along with the connection to the air conduit.

[0406] In certain examples, specific instruction precautions may be provided depending on the nature of the components being set up (e.g., the patient interface, the air conduit). For example, if a connection is provided between the patient interface and the air conduit and the type of connector used between these two components includes dual clips on either side of the connector, the instruction items displayed on the display screen may include precautions to alert the patient to check if both sides of the connector are securely clipped. Such pinpoint instruction items can avoid problems (e.g., leakage occurring during connection).

[0407] The display screen 132 instructs the patient to check the fit and operation of the mask. These instructions may include requesting the patient to lie down and get up a specific number of times, thereby confirming that the patient interface fits well when the patient makes predicted movements. The operation of the mask can be checked by controlling the operation of the RPT device 4000 through a test cycle, during which pressurized breathable gas is provided to the patient via the patient interface 3000. In some examples, the components of the system can be structured to automatically determine proper operation. For example, the patient interface and / or the air conduit can be structured to electronically determine mutually that they are correctly connected. Data on such determinations can be transmitted to a computing device.

[0408] Options indicating that the mask is not operating properly and / or that discomfort is felt may be provided to the patient. If the patient indicates that the mask is not operating properly and / or that discomfort is felt, one or more steps of the setup may be repeated. As shown on the display screen 132, options for receiving assistance with the setup of the mask may be provided to the patient. This assistance may be provided via a video conference with a technician, and guidance regarding the setup may be provided to the patient based on video / images provided by the technician. In some examples, in the form in which the assistance is provided, access is made to further instructions (e.g., images, videos or animations) to obtain more detailed mask fitting instructions from a remote source (e.g., remote external device 4286). This assistance may be provided by an artificial intelligence that guides the setup of the mask.

[0409] Options indicating that the mask is operating properly and that comfort is felt may be provided to the patient. If the patient indicates that the mask is operating properly and / or that comfort is felt, the display screen 140 may be displayed for the capture of images and / or videos of the patient and the mask. The application guides the patient via the display screen 140 and / or auditory instructions to capture images and / or videos from different positions and / or orientations. The captured images and / or videos may be stored in the local memory of the device and / or transferred to a remote computing device (e.g., remote external device 4286).

[0410] A display screen 142 indicating completion of the setup process of the patient interface is displayed. In a particular example, the completion of the setup of a component and / or a given display screen can be recorded in a data file or the like and associated with the baseline image. In a particular example, data on the progress of the patient in the setup of the device can be sent to a remote computing device. This enables a remote user (e.g., a medical or customer support person) to confirm that the setup of a given component is complete and / or to confirm that the patient interface is properly set up based on the captured image. The medical or customer support person can provide a confirmation notice that the captured image is available as a baseline if the patient is experiencing problems with the patient interface. 5.7.4.2 Exemplary Display Screens for Detecting Problems Related to the Patient Interface

[0411] FIG. 8B includes a series of display screens that assist the user in positioning and modifying the setup of the mask (patient interface). These display screens can be displayed on the display of the local external device 4288 and / or the RPT device 4000. Some of the display screens shown in FIG. 8B include instructions and show the mask of a particular feature, but the examples of the present technology are not limited to this. One or more instructions and / or display screens may not be shown and / or additional display screens may be added depending on other instructions and / or the type of mask the patient is using and the problems identified for a particular patient interface.

[0412] The display screen 200 provides the patient with options indicating that the patient is experiencing problems related to the mask. The display screen 120 can be automatically displayed based on the computing system and it is determined that the user interface has not been used and / or the operation of the RPT device is inappropriate and / or inconsistent based on a predefined schedule.

[0413] The display screen 202 indicates that the patient needs to capture an image or video of the patient with the mask. The patient can be guided through the display screen 202 and / or auditory instructions so that the capture of the image and / or video is performed from different positions and / or orientations. The captured image and / or video can be used to obtain a scan of the patient and the patient interface. The captured image and / or video can be stored in the local memory of the device and / or transferred to a remote computing device (e.g., remote external device 4286).

[0414] Analysis of the captured image can determine potential problems related to the setup and / or positioning of the mask on the patient's head. The display screen 204 shows the patient potential problems related to the patient interface. These problems can be identified through text, images, and / or animations. Within the display screen 204, these problems are identified by numbers overlaid on one of the captured images, and each number indicates the order of importance of the potential problems identified by the system.

[0415] The display screens 206 and 208 identify and provide instructions for problem correction. The display screens 206 and 208 may include images, videos, and / or animations showing the correct setting and / or positioning of the mask. The display screen 206 may be displayed in response to the user selecting a first problem shown within the display screen 204. The display screen 208 may be displayed in response to the user selecting a second problem shown within the display screen 204. After displaying information about one or more of the identified problems, the display screen 210 may display a request to the user to indicate whether the problem has been corrected. If the problem has been corrected, the detection of the mask problem may be completed. If the problem has not been corrected, the display screen 202 may be displayed to repeat the image capture for further problem detection related to the patient interface. In some examples, the display screen 204 and / or 206 may display information for problem correction based on data received from one or more sensors disposed within the mask and / or headgear, and may update the displayed information in real time based on the sensors that received the data.

[0416] In some examples, after problems related to the patient interface have been corrected (with a "yes" in the display screen 210), the display screen 140 in FIG. 8A may be displayed requesting that additional images and / or videos be captured as an alternative to the previously used baseline image or as an addition to the existing baseline image. In some examples, the determination of whether the problem has been corrected or not may be automatically made based on data received from one or more sensors disposed within the mask and / or headgear. 5.7.4.3 Exemplary display screens for guiding the fitting of a patient interface using captured patient images

[0417] FIG. 8C shows a series of display screens that can be used to assist a user in positioning a patient interface. One or more of the screens shown in FIG. 8C can be used within the series of screens shown in FIGS. 8A and / or 8B. Display screen 302 shows the headgear selected for or by the user. The illustrated headgear can correspond to the type, size, and configuration of the headgear selected by the system for the patient. Display screen 302 can include an instruction to attach different parts of the headgear to each other.

[0418] Display screen 304 displays an image of the headgear attached to the mask and an instruction to attach the headgear to the mask. The illustrated mask can correspond to the type, size, and configuration of the mask selected by the system for the patient. These instructions can include instructions for the headgear settings that the user needs to perform before wearing the patient interface. These instructions can be generated based on the captured image of the patient, usage history, and / or data stored in the database.

[0419] The display screen 306 displays an image of a patient interface provided on a virtual patient. In some examples, the virtual patient can be generated from the patient's previously captured image or can correspond to an avatar generated based on the user's image. The patient interface selected for the user can be overlaid on the patient's face by augmented reality. The patient interface can be overlaid on the patient's face based on features of the patient extracted from the patient's image. In some examples, the image shown on the display screen 306 is a real-time image of the patient taken from, for example, the feed of a camera facing the front of a mobile device. The determination of the positioning of a particular portion of the patient interface can be made by detecting the positioning of one or more reference markers 3362. For example, the reference markers 3362 can be used to confirm the position of the headgear strap. This can be used to determine the optimal fit for the patient. In some examples, the display screen 306 can include instructions for adjusting the headgear strap (e.g., shortening or tightening the strap) and / or instructions for adjusting the positioning of the strap and / or mask. These instructions can be generated based on the patient's captured image, usage history, and / or data stored in a database. These instructions can be provided by overlaying symbols such as arrows (to provide adjustment feedback to the user) on the image. In other examples, these instructions can take the form of auditory cues.

[0420] One or more of the display screens shown in FIGS. 8A - 8C can include a three-dimensional model of the patient and / or patient interface that enables the user to change the display state of the patient and / or patient interface based on user input. For example, the user input can change the orientation and / or positioning of a virtual camera used to capture an image of the patient and / or patient interface as the display target for the patient. 5.7.4.4 Exemplary Computing Device

[0421] FIG. 9 shows a block diagram of an exemplary computing device 600 (which may also be referred to, for example, as a "computing device", "computer system", or "computing system") herein. In a particular example, the computing device 600 may be provided within a local external device 4288. In a particular example, the computing device 600 may correspond to a central controller 4230.

[0422] In a particular example, the computing device 600 includes one or more of the following: a processing system 602 including one or more hardware processors (e.g., a central processing unit or CPU); one or more memory devices 606; one or more network interface devices 618; one or more display interfaces 614; and one or more user input adapters 610. The elements of the computing device 600 may communicate with each other via a system bus 604. Further, in some examples, the computing device 600 is connected to or includes a display device 616, a user input device 612, a camera 630, a database 620, and / or an external resource 622 (which may be another instance of the computing device 600). As described below, these elements (e.g., the processing system 602, the memory device 606, the network interface device 618, the display interface 614, the user input adapter 610, the camera 630, the display device 616) are hardware devices (e.g., electronic circuits or combinations of circuits) configured to perform various different functions for the computing device 600.

[0423] In some examples, each or any of the processors (e.g., CPU 1, 2, 3, or 4) of the processing system 602 is or includes, for example, a single-core processor or a multi-core processor, a microprocessor (e.g., which may also be referred to as a central processing unit or CPU), a digital signal processor (DSP), a microprocessor associated with a DSP core, an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA) circuit, and / or a system-on-chip (SOC) (e.g., an integrated circuit including a CPU and other hardware components (e.g., memory, networking interface)). In a particular example, each or any of the processors may use an instruction set architecture (e.g., x86 or Advanced RISC Machine (ARM)).

[0424] In some examples, each or any of the memory devices 606 is or includes a random access memory (RAM) (e.g., dynamic RAM (DRAM) or static RAM (SRAM)), flash memory (e.g., based on NAND or NOR technology), a hard disk, a magneto-optical medium, an optical medium, a cache memory, registers (e.g., which hold instruction items), or other types of devices that perform volatile or non-volatile storage of data and / or instruction items (e.g., software executed on or by the processors of the processing system 602). The memory device 606 is an example of a non-transitory computer-readable storage medium.

[0425] In some examples, each or any of the network interface devices 618 includes one or more circuits (e.g., a baseband processor and / or a wired transceiver or a wireless transceiver), and executes one or more wired communication technologies (e.g., Ethernet (IEEE 802.3)) and / or wireless communication technologies (e.g., Bluetooth®, WiFi® (IEEE 802.11), GSM, CDMA2000, UMTS, LTE, the first layer, the second layer and / or higher layers for LTE-Advanced (LTE-A) and / or other short-range, medium-range and / or long-range wireless communication technologies). The transceiver may include circuitry for a transmitter and a receiver. The transmitter and the receiver may share a common housing and may share some or all of the circuitry within the housing for transmitting and receiving. In some examples, the transmitter and the receiver of the transceiver may not share any common circuitry and / or may be provided in the same or separate housings.

[0426] In some examples, each or any of the display interfaces 614 is or includes one or more circuits that perform the following: receiving data from a processor of the processing system 602, generating and / or outputting corresponding image data (e.g., via a discrete GPU, an integrated GPU, a CPU that performs graphical processing, etc.) based on the received data, and outputting the image data to a display device 616 (for displaying the image data) via (e.g., a high-definition multimedia interface (HDMI®), a DisplayPort interface, a video graphics array (VGA) interface, a digital video interface (DVI), etc.). Alternatively or additionally, in some examples, each or any of the display interfaces 614 is or includes, for example, a video card, a video adapter, or a graphics processing unit (GPU).

[0427] In some examples, each or any of the user input adapters 610 is or includes one or more circuits. These circuits receive and process user input data from one or more user input devices 612 (which are included in the computing device 600, attached to the computing device 600, or otherwise communicate with the computing device 600), and output data to the processor 602 based on the received input data. Alternatively or additionally, in some examples, each or any of the user input adapters 610 is or includes, for example, a PS / 2 interface, a USB interface, a touch screen controller, etc.; and / or the user input adapter 610 can facilitate input from the user input device 612. The user input device 612 can include, for example, a keyboard, a mouse, a trackpad, a touch screen, voice input, etc. In certain examples, the user input adapter 610 can be configured to process data from other types of input sources that are not from the user. For example, the user input adapter 610 (e.g., the input adapter) can process data from one or more sensors (e.g., flow, pressure, temperature, or other types of sensors).

[0428] In some examples, display device 616 can be a liquid crystal display (LCD) monitor, a light emitting diode (LED) display, or other types of display devices. In an example where display device 616 is a component of computing device 600 (e.g., the computing device and the display device are included within an integrated housing such as a mobile or tablet device), display device 616 can be a touch screen display (e.g., using capacitive or resistive technology that senses touch) or a non-touch screen display. In an example where display device 616 is connected to computing device 600 (e.g., is external to computing device 600 and communicates with computing device 600 via wired communication technology and / or wireless communication technology), display device 616 can be, for example, an external monitor, a projector, a television, a display screen, and the like.

[0429] In various examples, computing device 600 includes one or two or three or four or more or any of the above-described elements (e.g., processing system 602, CPU1, 2, 3, or 4, memory device 606, network interface device 618, display interface 6514, and user input adapter 610). In some examples, computing device 600 includes one or more of the following: a processing system 602 that includes a hardware processor (e.g., CPU1, 2, 3, and / or 4); a storage system that includes a memory or a memory device; and a network interface system that includes network interface device 618.

[0430] Computing device 600 can be arranged in a number of different ways in a variety of examples. By way of example only, computing device 600 can be arranged such that the processor includes the following: a multi-core (or single-core) processor; a first network interface device (e.g., implementing WiFi (registered trademark), Bluetooth (registered trademark), NFC, etc.); a second network interface device implementing one or more cellular communication technologies (e.g., 3G, 4G LTE, CDMA, etc.); a memory or storage device (e.g., RAM, flash memory, or hard disk). The processor, the first network interface device, the second network interface device, and the memory device can be integrated as part of the same SOC (e.g., one integrated circuit chip). As another example, computing device 600 can be arranged such that: the processor includes two, three, four, five, or more multi-core processors; network interface device 618 includes a first network interface device implementing Ethernet and a second network interface device implementing WiFi (registered trademark) and / or Bluetooth (registered trademark); and memory device 606 can include RAM and a storage device in the form of flash memory or a hard disk.

[0431] Whenever it is described in this document that a software module or software process performs any action, it is understood that the action is actually performed by the underlying hardware elements in accordance with an instruction item that includes the software module.

[0432] The hardware configurations illustrated in FIG. 9 and described above are by way of example, and the content described herein can be used in connection with a variety of different hardware architectures and elements. For example, in the figures in this document, individual functional blocks / action blocks are illustrated, but in various examples, the functions of these blocks can be performed using the following: (a) individual hardware circuits, (b) using an application specific integrated circuit (ASIC) specifically configured to perform the described function / action, (c) using one or more digital signal processors (DSPs) specifically configured to perform the described function / action, (d) using the hardware configuration described above with reference to FIG. 6, (e) through other hardware arrangements, architectures and configurations and / or through a combination of the techniques described in (a)-(e).

[0433] In certain examples, the techniques herein improve the use of the patient interface. Such improvements can be based on a comparison between a baseline and captured images including the patient and the patient interface. In certain examples, the techniques herein improve patient comfort in the home use of a patient's medical device without the need for setup and instruction by a medical professional regarding the use of the patient interface and / or correction of issues related to the use of the patient interface. 5.8 Respiratory Therapy Modes

[0434] A variety of respiratory therapy modes can be performed by the disclosed respiratory therapy system. 5.8.1 CPAP Therapy

[0435] In some embodiments of respiratory pressure therapy, the central controller 4230 sets the therapy pressure Pt as part of a therapy parameter determination algorithm 4329 according to the therapy pressure equation (1). In some such embodiments, since the amplitude A is equal to zero, the therapy pressure Pt (which represents the target value achieved by the interface pressure Pm at the current instant in time) is likewise equal to the base pressure P0 throughout the respiratory cycle. Such embodiments are mainly grouped under the heading of CPAP therapy. In such embodiments, the therapy engine module 4320 for determining the phase Φ or the waveform template Π(Φ) is not required.

[0436] In CPAP therapy, the base pressure P0 can be a constant value, either hard-coded or manually input into the RPT device 4000. The central controller 4230 can repeatedly calculate the base pressure P0 as a function of an index or measurement of sleep disordered breathing (e.g., one or more of flow limitation, apnea, hypopnea, patency, and snoring) returned from each algorithm in the therapy engine module 4320. This alternative is also referred to as APAP therapy.

[0437] Figure 4E is a flowchart showing a method 4500 executed by the central controller 4230. In the method 4500, when the pressure assist A is equal to zero, the base pressure P0 is continuously calculated as part of the execution of the APAP therapy of the therapy parameter determination algorithm 4329.

[0438] Method 4500 starts from step 4520. In step 4520, the central controller 4230 compares the measurement of the presence of apnea / hypopnea with a first threshold and determines whether the measurement of the presence of apnea / hypopnea exceeds the first threshold over a predetermined period (which indicates the occurrence of apnea / hypopnea). If so, method 4500 proceeds to step 4540; otherwise, method 4500 proceeds to step 4530. In step 4540, the central controller 4230 compares the measurement of airway patency with a second threshold. If the measurement of airway patency exceeds the second threshold, it indicates that the airway is patent, and the detected apnea / hypopnea is considered central, and method 4500 proceeds to step 4560. If the measurement of airway patency does not exceed the second threshold, the apnea / hypopnea is considered obstructive, and method 4500 proceeds to step 4550.

[0439] In step 4530, the central controller 4230 compares the measurement of flow limitation with a third threshold. If the measurement of flow limitation exceeds the third threshold, it indicates that the inspiratory flow is restricted. In that case, method 4500 proceeds to step 4550. If the measurement of flow limitation does not exceed the third threshold, method 4500 proceeds to step 4560.

[0440] In step 4550, if the obtained treatment pressure Pt does not exceed the maximum treatment pressure Pmax, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment ΔP. In one embodiment, the predetermined pressure increment ΔP and the maximum treatment pressure Pmax are 1 cmH2O and 25 cmH2O respectively. In other embodiments, 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 embodiments, 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. Next, method 4500 returns to step 4520.

[0441] In step 4560, if the decreased base pressure P0 does not fall below the minimum treatment pressure Pmin, the central controller 4230 decreases the base pressure P0 by only the decrement. Next, method 4500 returns to step 4520. In one embodiment, since the decrement is proportional to the value of P0 - Pmin, in the absence of detected events, the decrease of P0 to the minimum treatment pressure Pmin is exponential. In one embodiment, the constant of the proportional relationship is set such that the time constant τ of the exponential decrease of P0 is 60 minutes and the minimum treatment pressure Pmin is 4 cmH2O. In other embodiments, the time constant τ can be shortened to 1 minute and lengthened to 300 minutes, or can be shortened to 5 minutes and lengthened to 180 minutes. In other embodiments, the minimum treatment pressure Pmin can be lowered to 0 cmH2O and raised to 8 cmH2O, or can be lowered to 2 cmH2O and raised to 6 cmH2O. Alternatively, the decrement of P0 may be predetermined such that the decrease of P0 to the minimum treatment pressure Pmin is linear in the absence of detected events. 5.8.2 Bilevel Therapy

[0442] In other embodiments of this form of the present technology, the value of the amplitude A in equation (1) can be positive. Such embodiments are known as bilevel therapy. Because when the treatment pressure Pt is determined 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 synchronization with the patient 1000's spontaneous breathing 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 (known as IPAP) at the start or during inspiration, and decreases the treatment pressure Pt to the base pressure P0 (known as EPAP) at the start or during expiration.

[0443] In some forms of bilevel therapy, the IPAP is the therapeutic pressure for the same purpose as the therapeutic pressure in the CPAP therapy mode, the EPAP is the value obtained by subtracting the amplitude A from the IPAP, and has a "small" value (a few cmH2O), also called expiratory pressure relief (EPR). Such a form is also called CPAP therapy using EPR and is generally considered to be more comfortable than direct CPAP therapy. In the case of CPAP therapy using EPR, either or both of the IPAP and EPAP can be a fixed value, hard-coded or manually input into the RPT device 4000. Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate the IPAP and / or EPAP during CPAP using EPR. In this alternative, the treatment parameter determination algorithm 4329 repeatedly calculates the EPAP and / or IPAP as a function of the index or measurement of sleep disordered breathing returned from each algorithm in the treatment engine module 4320. This is done in the same manner as the calculation of the base pressure P0 in the above-described APAP therapy.

[0444] In other forms of bilevel therapy, the amplitude A is large enough so that the RPT device 4000 performs some or all of the patient 1000's breathing movements. In such a form, known as pressure-assisted ventilation therapy, the amplitude A is called pressure assistance or swing. In pressure-assisted ventilation therapy, the IPAP is the base pressure P0 + pressure assistance A, and the EPAP is the base pressure P0.

[0445] In some forms of pressure-assisted ventilation therapy, known as constant pressure-assisted ventilation therapy, the pressure assistance A is fixed at a predetermined value (for example, 10 cmH2O). The predetermined pressure assistance value is a setting of the RPT device 4000 and can be hard-coded, for example, at the time of configuration of the RPT device 4000 or set by manual input through the input device 4220.

[0446] In other forms of pressure-assisted ventilation therapy, widely known as servo ventilation, the treatment parameter determination algorithm 4329 takes as inputs a certain currently measured or estimated parameter of the respiratory cycle (e.g., the current measured Vent of ventilation) and a target value of the respiratory parameter (e.g., the target value Vtgt of ventilation), and repeatedly adjusts the parameters of Equation (1) to bring the current measurement of the respiratory parameter closer to the target value. In the form of servo-ventilation known as adaptive servo ventilation (ASV) used in CSR treatment, the respiratory parameter is ventilation, and the target ventilation value Vtgt is calculated by the target ventilation determination algorithm 4328 from the typical recent ventilation Vtyp as described above.

[0447] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control method that repeatedly calculates the pressure assistance A so that the current measurement of the respiratory parameter reaches the target value. One such control method is proportional-integral (PI) control. In one embodiment of PI control suitable for the ASV mode set such that the target ventilation Vtgt is slightly lower than the typical recent ventilation Vtyp, the pressure assistance A is repeatedly calculated as follows:

[0448]

Equation

[0449] Here, G is the gain of the PI control. When the value of the gain G increases, the feedback in the treatment engine module 4320 can become positive. When the value of the gain G decreases, a certain remaining untreated CSR or central sleep apnea may occur. In some embodiments, the gain G is fixed at a predetermined value (e.g., -0.4 cmH2O / (L / min) / sec). Alternatively, the gain G can be changed between treatment sessions until a value substantially free of CSR is reached (starting from a low value initially and increasing between sessions). Conventional means for retrospectively analyzing the parameters of a treatment session to evaluate the severity of CSR during the treatment session can be used in such embodiments. In yet other embodiments, the gain G can vary according to the difference between the current measurement of ventilation Vent and the target ventilation Vtgt.

[0450] Other servo ventilation control methods that can be applied by the treatment parameter determination algorithm 4329 include proportional (P), proportional derivative (PD), and proportional integral derivative (PID).

[0451] The value of the pressure assist A calculated via equation (2) can be clipped to a range defined as [Amin, Amax]. In this embodiment, the pressure assist A is set as default at the minimum pressure assist Amin until the measurement of the current ventilation Vent is below the target ventilation Vtgt. When the measurement of the current ventilation Vent falls below the target ventilation Vtgt, A begins to increase and decreases to Amin only when Vent exceeds Vtgt again.

[0452] The pressure assist limits Amin and Amax are settings of the RPT device 4000 and are, for example, hard - coded during the configuration of the RPT device 4000 or set by manual input through the input device 4220.

[0453] In the pressure-assisted ventilation treatment mode, EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP treatment, EPAP can be a constant value, which is defined or determined during titration. Such a constant EPAP can be set, for example, by hard-coding during the configuration of the RPT device 4000 or by manual input through the input device 4220. This alternative is also called fixed EPAP pressure-assisted ventilation treatment. The titration of EPAP for a given patient can be performed by a clinician during a titration session using PSG for the purpose of preventing obstructive apnea, whereby airway patency is maintained for pressure-assisted ventilation treatment in a manner similar to the titration of the base pressure P0 in constant CPAP treatment.

[0454] Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate the base pressure P0 during pressure-assisted ventilation treatment. In such an embodiment, the treatment parameter determination algorithm 4329 repeatedly calculates EPAP as a function of the index or measurement of sleep disordered breathing (e.g., one or more of flow limitation, apnea, hypopnea, patency, and snoring) returned from each algorithm in the treatment engine module 4320. Since the continuous calculation of EPAP is similar to the manual adjustment of EPAP by a clinician during titration of EPAP, this process is also called automatic titration of EPAP, and the treatment mode is known as automatic titration EPAP pressure-assisted ventilation treatment or automatic EPAP pressure-assisted ventilation treatment. 5.8.3 High-flow treatment

[0455] In other forms of respiratory therapy, the pressure of the air flow is not controlled because it is used for respiratory pressure therapy. Instead, the central controller 4230 controls the pressure generator 4140 to deliver an air flow (controlled so that the device flow Qd becomes the treatment flow or target flow Qtgt, which is typically positive over the entire patient respiratory cycle) to the pressure generator 4140. Such forms are mainly grouped under the heading of flow therapy. In flow therapy, the treatment flow Qtgt can be a constant value and can be hard-coded or manually input into the RPT device 4000. If the treatment flow Qtgt is sufficient to exceed the patient's peak inspiratory flow, the treatment is mainly referred to as high flow therapy (HFT). Alternatively, the treatment flow can be a profile Qtgt(t) that varies over the respiratory cycle. 5.9 Glossary

[0456] For the purposes of the disclosure of the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may also apply. 5.9.1 General

[0457] Air: In certain forms of the present technology, air may mean the atmosphere, and in other forms of the present technology, air may mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0458] In certain forms of the present technology, the term "ambient" should be taken to mean (i) outside the treatment system or the patient, and (ii) what directly surrounds the treatment system or the patient.

[0459] For example, the ambient humidity for a humidifier can be the humidity of the air that directly surrounds the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0460] In another example, the ambient pressure can be the pressure directly around or outside the body.

[0461] In certain embodiments, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room other than the noise generated, for example, from the RPT device or from the mask or patient interface. The ambient noise can originate from sources outside the room.

[0462] Automatic positive airway pressure (APAP) therapy: A form of CPAP therapy that can automatically adjust the therapy pressure between a minimum and a maximum limit, for example, during the breathing cycle, depending on the presence or absence of signs of SDB onset.

[0463] Continuous positive airway pressure (CPAP) therapy: A respiratory pressure therapy in which the therapy pressure is substantially constant throughout the patient's breathing cycle. In some embodiments, the pressure at the airway inlet slightly increases during exhalation and slightly decreases during inhalation. In some embodiments, the pressure varies between different breathing cycles of the patient (e.g., increases in response to detection of signs of partial upper airway obstruction and decreases in the absence of notification of partial upper airway obstruction).

[0464] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous amount. In some cases, when referring to flow rate, a scalar quantity (i.e., a quantity having only magnitude) is meant. In other cases, when referring to flow rate, a vector quantity (i.e., a quantity having both magnitude and direction) is meant. Flow rate may be assigned the symbol Q. "Flow rate" may be abbreviated as "airflow" in some cases.

[0465] In an example of a patient's breathing, the flow can be nominally positive pressure for the inhalation portion of the patient's breathing cycle and thus can be negative for the exhalation portion of the patient's breathing cycle. The device flow Qd is the flow of air exiting the RPT device. The total flow Qt is the flow of air and any supplemental gas reaching the patient interface via the air circuit. The ventilation flow Qv is the flow of air exiting the ventilation section to allow for the outflow of the exhaled gas. The leak flow Ql is the flow of leakage from the patient interface system or other locations. The breathing flow Qr is the flow of air received into the patient's respiratory system.

[0466] Flow therapy: A respiratory therapy that includes delivering an air flow to the airway inlet at a controlled flow rate, referred to as the therapy flow rate, which is normally positive pressure throughout the patient's breathing cycle.

[0467] Humidifier: The word "humidifier" is interpreted to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0468] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage can occur due to an incomplete seal between the mask and the patient's face. In another example, leakage can occur at a swivel elbow to the surroundings.

[0469] Noise conduction (acoustic): In this document, conduction noise refers to noise conveyed to the patient by an air pressure path (e.g., the air circuit and the patient interface and the air within). In one form, conduction noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0470] Noise Emission (Acoustic): In this document, emitted noise refers to the noise conveyed to the patient by the surrounding air. In one form, the emitted noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO3744.

[0471] Noise Ventilation (Acoustic): In this document, ventilation noise refers to the noise generated by the air flow through any ventilation part (e.g., ventilation holes in the patient interface).

[0472] Patient: A person with or without a respiratory disease.

[0473] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, g-f / cm 2 and hectopascal). 1 cmH2O is equal to 1 g-f / cm 2 and approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m 2 = 1 millibar ~ 0.001 atm). In this specification, unless otherwise specified, pressure is given in the unit of cmH2O.

[0474] The pressure in the patient interface is denoted by the symbol Pm, and the treatment pressure representing the target value to be achieved by the interface pressure Pm at the current time is denoted by the symbol Pt.

[0475] Respiratory Pressure Therapy (RPT): Addition of an air supply to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0476] Ventilator: A mechanical device that provides pressure assistance when the patient performs part or all of the breathing motion. 5.9.1.1 Materials

[0477] Silicone or silicone elastomer: a synthetic rubber. As used herein, when referring to silicone, it refers to liquid silicone rubber (LSR) or compression molding silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this trademark). Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of the exemplary form of LSR, when measured by ASTM D2240, is about 35 to about 45.

[0478] Polycarbonate: a thermoplastic polymer of bisphenol A carbonate. 5.9.1.2 Mechanical properties

[0479] Elasticity: the ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0480] Elastic: releases substantially all energy during unloading. For example, includes certain silicones and thermoplastic elastomers.

[0481] Hardness: the ability of a material to resist deformation (e.g., as described by the Young's modulus or an indentation hardness scale measured on a standardized sample size). A "soft" material may include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure. A "hard" material may include polycarbonate, polypropylene, steel, or aluminum, and cannot be easily deformed, for example, under finger pressure.

[0482] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, tension, bending, or torsion). A structure or component may provide different resistance in different directions. The antonym of stiffness is flexibility.

[0483] Flexible structure or component: A structure or component that, when supported under its own weight, changes shape (e.g., bends) within a relatively short period (e.g., 1 second).

[0484] Rigid structure or component: A structure or component that undergoes substantially no shape change when subjected to the loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against the patient's airway inlet under a pressure load of, for example, approximately 20 - 30 cmH2O.

[0485] As an example, an I-beam may include different bending rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction. 5.9.2 Respiratory cycle

[0486] Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's effort. Central apnea refers to a state where apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to a state where a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0487] Respiratory rate: The patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0488] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0489] Effort (respiratory): Respiratory effort is said to refer to the movement performed by a person's spontaneous breathing while attempting to breathe.

[0490] Expiratory portion of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0491] Flow limitation: Flow limitation is construed as a situation in a patient's respiration where an increase in the patient's effort does not cause a corresponding increase in flow. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0492] Types of waveforms of inspiratory flow limitation: (i) Flattening: After an ascent, a relatively flat portion follows, and then a descent occurs. (ii) M-shaped: Having one local peak at the rise and one at the fall, with a relatively flat portion between these two peaks. (iii) Chair-shaped: Having a single local peak that occurs in the rising portion, followed by a relatively flat portion. (iv) Inverse chair-shaped: A single local peak follows a relatively flat portion, and this peak occurs at the fall.

[0493] Respiratory hypopnea: According to some definitions, respiratory hypopnea means a decrease in flow rather than an interruption of flow. In one form, when a flow decrease below a threshold velocity continues over a duration, it is said that respiratory hypopnea has occurred. When respiratory hypopnea is detected due to a decrease in respiratory effort, it is said that central respiratory hypopnea has occurred. In one form in adults, any of the following may occur and be regarded as respiratory hypopnea: (i) A 30% decrease in patient respiration for at least 10 seconds + associated 4% desaturation, or, (ii) A decrease (less than 50%) in patient respiration that continues for at least 10 seconds, with associated desaturation of at least 3% or arousal occurring.

[0494] Hyperventilation: The flow increases to a level higher than the normal flow rate.

[0495] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0496] Patency (airway): The degree to which the airway is open or the range over which the airway is open. Airway patency is an opening. Quantification of airway patency can be performed, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0497] Positive end-expiratory pressure (PEEP): A pressure that exceeds the atmosphere in the lungs and exists at the end of expiration.

[0498] Peak flow (Qpeak): The maximum flow value in the inspiratory portion of the respiratory flow waveform.

[0499] Respiratory flow, air flow, patient air flow, respiratory air flow (Qr): These terms can be understood to refer to the estimation of the respiratory air flow of an RPT device and are the actual respiratory flow of the patient, usually expressed in liters per minute, the "true respiratory flow" or are used in contrast to the "true respiratory flow".

[0500] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort. In principle, since the inspiratory volume Vi (the amount of air inhaled) is equal to the expiratory volume Ve (the amount of air exhaled), a single tidal volume Vt can be defined as equal to either amount. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inspiratory volume Vi and the expiratory volume Ve).

[0501] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0502] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0503] (Total) time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0504] Typical recent ventilation: Ventilation values that tend to cluster around the most recent value of Vent over a given time scale (i.e., the degree of tendency of the center of the most recent values of ventilation).

[0505] Upper airway obstruction (UAO): Includes both partial upper airway obstruction and total upper airway obstruction. May be associated with a state of flow limitation where flow may either slightly increase or decrease along with an increase in the pressure difference across the upper airway (Starling resistor behavior).

[0506] Ventilation (Vent): Measurement of the gas exchange rate performed by a patient's respiratory system. Measurement of ventilation may include one or both of the inspiratory and expiratory flows per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation may simply be given as volume and is understood as volume per minute. 5.9.3 Ventilation

[0507] Adaptive servo - ventilator (ASV): A servo - ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's respiratory characteristics).

[0508] Backup rate: A parameter of the ventilator that establishes the minimum respiratory rate (typically, breaths per minute) delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0509] Cycle: The end of the inspiratory phase of the ventilator. When delivering breaths from the ventilator to a patient who is breathing spontaneously, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to cycle to stop breath delivery.

[0510] Expiratory positive airway pressure (EPAP): The base pressure to which a pressure that varies within the breath is added for the generation of the desired interface pressure that the ventilator attempts to achieve at a given time.

[0511] End-expiratory pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory portion of a breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ) = 0 when Φ = 1), the EEP is equal to the EPAP.

[0512] Inspiratory positive airway pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of a breath.

[0513] Pressure assist: A number indicating the pressure increase during ventilator inspiration compared to ventilator expiration, mainly meaning the pressure difference between the maximum value during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure assist means the difference that the ventilator attempts to achieve (rather than the difference that the ventilator actually achieves).

[0514] Servo ventilator: A ventilator with patient ventilation and target ventilation, which adjusts the pressure assist level to bring patient ventilation closer to the target ventilation.

[0515] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the start of a breath in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period, the device automatically starts breath delivery.

[0516] Swing: A term corresponding to pressure assist.

[0517] Trigger: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be triggered to deliver the breath when the patient himself / herself starts the inspiratory portion of the breathing cycle. 5.9.4 Anatomical Structure 5.9.4.1 Facial Anatomical Structure

[0518] Alar: The outer wall or "wing" outside each nostril (plural: alar)

[0519] Alar angle:

[0520] Alare: The outermost point on the alar wing.

[0521] Alar curvature (or alar apex) point: The rearmost point on the curvilinear reference line of each alar wing, seen at the crease formed by the junction of the alar wing and the cheek.

[0522] Auricle: The entire visible part of the ear.

[0523] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0524] (Nasal) cartilage skeleton: The nasal cartilage skeleton includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0525] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip.

[0526] Columella angle: The angle between a line drawn through the midpoint of the nasal aperture and a line drawn perpendicular to the Frankfurt horizontal while intersecting the subnasal point.

[0527] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the left auricular point. The auricular point is the deepest point from the upper notch to the earlobe of the auricle.

[0528] Glabella: A point located in the soft tissue and most prominent on the mid-sagittal plane of the forehead.

[0529] Lateral nasal cartilage: Generally a triangular plate of cartilage. Its upper peripheral edge is attached to the nasal bone and the frontal process of the maxilla, and its lower peripheral edge is connected to the major alar cartilage.

[0530] Lip, lower (Lower lip: labrale inferius):

[0531] Lip, upper (Upper lip: labrale superius):

[0532] Greater alar cartilage: A plate of cartilage that is located inferior to the lateral nasal cartilages. It curves around the anterior portion of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that includes three or four alar minor cartilages.

[0533] Nostril (nasal cavity): Generally an elliptical alar aperture that forms the entrance to the nasal cavity. The singular form of nares is naris (nasal cavity). These nares are separated by the nasal septum.

[0534] Nasolabial sulcus or nasolabial fold: A skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0535] Nasolabial angle: The angle between the columella and the upper lip, which intersects the subnasale.

[0536] Lower ear attachment point: The lowest point of attachment of the auricle to the facial skin.

[0537] Upper ear attachment point: The highest point of attachment of the auricle to the facial skin.

[0538] Tip of nose point: The most prominent point or tip of the nose, which can be identified in the side view of the remaining part of the head portion.

[0539] Philtrum: A midline groove that extends from the inferior border of the nasal septum to the upper part of the lip in the upper lip region.

[0540] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0541] (Nasal) dorsum: The nasal dorsum is a midline elevation of the nose that extends from the sellion to the tip of the nose.

[0542] Sagittal plane: A vertical plane that extends from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides into right and left halves.

[0543] Sellion: The most concave point on the area of the fronto-nasal suture, located on the soft tissue.

[0544] Septal cartilage (nose): The septal cartilage is part of the septum and divides the anterior part of the nasal cavity.

[0545] Lowest alar point: The point at the lower periphery of the alar base, where the alar base joins the skin of the upper (superior) lip.

[0546] Subnasal point: The point located on the soft tissue where the columella joins the upper lip in the median sagittal plane.

[0547] Stomion: The most concave point in the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion. 5.9.4.2 Anatomical structure of the skull

[0548] Frontal bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the region known as the forehead.

[0549] Mandible: The mandible forms the lower jaw. The gonion is a bony prominence of the jaw that forms the jaw.

[0550] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward by the side of the nose and forms part of its outer boundary.

[0551] Nasal bone: The nasal bones are two small rectangular bones that vary in size and shape from person to person. The nasal bones are arranged side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0552] Nasion: The intersection of the frontal bone and the two nasal bones, which is a concave area directly provided between the eyes and the upper part of the nasal bridge.

[0553] Occipital bone: The occipital bone is located on the back and lower part of the skull. The occipital bone includes the foramen magnum, which is an elliptical hole through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0554] Orbit: A bony cavity in the skull that contains the eyeball.

[0555] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0556] Temporal bone: The temporal bones are located on the base and sides of the skull and support the part of the face known as the temple.

[0557] Cheekbone: The two cheekbones that are part of the face are located in the upper and outer parts of the face and form the cheek prominences. 5.9.4.3 Anatomical Structure of the Respiratory System

[0558] Diaphragm: A sheet of muscle that extends over the lower part of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0559] Larynx: The larynx or voice box that houses the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0560] Lung: The respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0561] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or nasal turbinate bones. In front of the nasal cavity is the nose, and behind it leads into the nasopharynx through the posterior nares.

[0562] Pharynx: The part of the throat located directly below (inferior) the nasal cavity and above the esophagus and larynx. The pharynx has traditionally been divided into the following three parts: the nasopharynx (upper pharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx). 5.9.5 Patient Interface

[0563] Anti - asphyxia valve (AAV): A component or sub - assembly of a mask system that, by opening into the atmosphere in a fail - safe manner, reduces the risk of excessive CO2 re - breathing by the patient.

[0564] Elbow: An elbow is an example of a structure that directs the axis of the airflow moving inside and changes the direction through 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. The elbow can have a substantially circular cross - section. In another form, the elbow can have an elliptical or rectangular cross - section. In a particular form, the elbow can be rotatable, for example, about 360 degrees with respect to an engaging component. In a particular form, the elbow can be removable from the engaging component, for example, via a snap connection. In a particular form, the elbow can be assembled to the engaging component via a one - time snap during manufacture, while being non - removable by the patient.

[0565] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non - airtight load - supporting structure in the mask. However, some forms of the mask frame can be airtight.

[0566] Headgear: Headgear is taken to mean a form of positioning and stabilization structure designed to be used on the head. For example, the headgear can include a collection of one or more struts, ties, and supplementary stiffeners configured to position and hold a patient interface at a predetermined position on the patient's face for the delivery of respiratory therapy. Some ties are formed of a soft, flexible elastic material (e.g., a laminated composite of foam and fabric).

[0567] Membrane: A membrane is taken to typically mean a thin element, preferably substantially resistant to bending and resistant to stretching.

[0568] Prenum Chamber: The mask prenum chamber is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell may form part of the wall of the mask prenum chamber.

[0569] Seal: When used as a noun (the "seal"), it can refer to the structure, and when used as a verb (to "seal"), it can refer to the effect. Two elements can be constructed and / or arranged such that they "seal" or obtain a "sealing" effect between them without requiring separate "seal" elements themselves.

[0570] Shell: The shell is taken to mean a relatively thin, curved structure having bending, tensile, and compressive rigidity. For example, the curved structural wall of a mask can be a shell. In some forms, the shell can be faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0571] Reinforcing member: A reinforcing member is taken to mean a structural component designed to increase the stiffness or flexibility of another component in at least one direction.

[0572] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0573] Swivel (noun): A sub-assembly of components that is configured to rotate preferably independently and preferably under low torque about a common axis. In one form, the swivel can be configured to rotate through an angle of at least 360 degrees. In another form, the swivel can be configured to rotate through an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably includes a pair of cylindrical conduits. In use, there is little leakage of air flow from the swivel.

[0574] Ty (noun): A structure designed to resist tension.

[0575] Ventilation part: (noun) A structure that allows air flow to the ambient air inside a mask or conduit, enabling a clinically effective washout of exhaled gas. For example, in a clinically effective washout, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and treatment pressure. 5.9.6 Shape of the structure

[0576] The product according to the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure may be bounded by two-dimensional surfaces. These surfaces can be distinguished using labels to describe the direction, position, function, or some other characteristic of the associated surface. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face contact (e.g., outer) surface and a separate non-face contact (e.g., lower or inner) surface. In another example, the structure may include a first surface and a second surface.

[0577] To facilitate the description of the shape and surface of the three-dimensional structure, first consider the cross-section at point p through the surface of the structure. Refer to FIGS. 3B to 3F. FIGS. 3B to 3F show an example of a cross-section at point p on the surface and an example of the resulting planar curve. FIGS. 3B to 3F also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some examples, this surface is described from the perspective of a fictional small person standing upright on the surface. 5.9.6.1 Curvature in One Dimension

[0578] The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0579] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (when this fictional small person leaves point p, they need to walk uphill). Refer to FIG. 3B (relatively large positive curvature compared to FIG. 3C) and FIG. 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often called concave.

[0580] Zero curvature: When the curve at p is a straight line, the curvature is taken as zero (when this fictional small person leaves point p, they can walk on a horizontal plane that is neither uphill nor downhill). Refer to FIG. 3D.

[0581] Negative curvature: When the curve at p bends in the direction away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (when this fictional small person leaves point p, they need to walk downhill). Refer to FIG. 3E (relatively small negative curvature compared to FIG. 3F) and FIG. 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often called convex. 5.9.6.2 Curvature of a Two-Dimensional Surface

[0582] The description of the shape at a given point on a two-dimensional surface according to this technique may include a plurality of vertical cross-sections. The plurality of cross-sections may cut the surface in a plane including the outward normal (the "normal plane"), and each cross-section may be taken in a different direction. As a result of each cross-section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point may have the same sign or different signs. The curvatures at that point each have a magnitude (e.g., relatively small). The planar curves in FIGS. 3B-3F may be examples of such a plurality of cross-sections at a particular point.

[0583] Principal curvatures and directions: The directions of the normal planes in which the curvature of the curve takes on its maximum and minimum values are called the principal directions. In the examples of FIGS. 3B-3F, since the maximum curvature occurs in FIG. 3B and the minimum occurs in FIG. 3F, FIGS. 3B and 3F are cross-sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0584] Region of the surface: A set of connected points on the surface. This set of points within the region may have similar characteristics (e.g., curvature or sign).

[0585] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one has a positive sign and the other has a negative sign), depending on the direction in which an imaginary person walking on the uphill or downhill would face.

[0586] Dome region: A region where the principal curvatures at each point have the same sign (both positive ("concave dome") or both negative ("convex dome")).

[0587] Cylindrical region: A region where one principal curvature is zero (or zero within manufacturing tolerances, for example), and the other principal curvature is non-zero.

[0588] Planar region: A region of the surface where both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0589] Edge of the surface: The boundary or limit of the surface or region.

[0590] Path: In certain embodiments of the present technology, "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve on a surface from f(0) to f(1)). In certain embodiments of the present technology, "path" can be described as a route or course that includes, for example, a set of points on a surface. (The path of a fictional person is the place to walk on the surface and is similar to a garden path).

[0591] Path length: In certain embodiments of the present technology, "path length" is taken to refer to the distance from f(0) to f(1) along the surface (i.e., the distance along the path on the surface). There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of a fictional person is the distance walked along the path on the surface).

[0592] Straight-line distance: The straight-line distance is the distance between two points on a surface without considering the surface. On a planar region, there is a distance along the edge of the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not be a path that has the same path length as the straight-line distance between two points. (For a fictional person, the straight-line distance corresponds to the "distance a crow flies"). 5.9.6.3 Space curve

[0593] Space curve: Unlike a planar curve, a space curve does not necessarily lie in any particular plane. A space curve can be closed, i.e., it has no endpoints. A space curve can be considered as a one-dimensional piece of three-dimensional space. A fictional person walking along the strands of a DNA helix walks along a space curve. A typical human left ear contains a left-handed helix (see Fig. 3Q). A typical human right ear contains a right-handed helix (see Fig. 3R). Fig. 3S shows a right-handed helix. The edges of a structure (e.g., the edge of a membrane or an impeller) can follow a space curve. In general, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of the way a curve deviates from a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with respect to the tangent vector, the normal vector, and the binormal vector at that point.

[0594] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies a direction and a magnitude from that point. The tangent unit vector is the unit vector that points in the same direction as the curve at that point. If a fictional person is flying along a curve and falls out of their vehicle at a particular point, the direction of the tangent vector is the direction in which the person should be moving.

[0595] Unit normal vector: When a fictional person is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the direction in which the tangent vector is changing is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0596] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (e.g., see Fig. 3P) or the left-hand rule (Fig. 3O).

[0597] Contact plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figs. 3O and 3P.

[0598] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation from the osculating plane of the curve. The torsion of a space curve lying in a plane is zero. When the deviation from the osculating plane of a space curve is relatively small, the magnitude of the torsion of that space curve is relatively small (e.g., a gently sloping helical path). When the deviation from the osculating plane of a space curve is relatively large, the magnitude of the torsion of that space curve is relatively large (e.g., a steeply sloping helical path). Referring to Fig. 3S, since T2 > T1, the magnitude of the torsion in the vicinity of the uppermost coil of the helix in Fig. 3S is greater than the magnitude of the torsion of the lowermost coil of the helix in Fig. 3S.

[0599] Referring to the right - hand rule of Fig. 3P, a space curve that bends in the direction of the right - hand binormal can be regarded as having a positive torsion in the right - hand direction (e.g., a right - hand helix as shown in Fig. 3S). A space curve that points in the direction away from the right - hand binormal can be regarded as having a negative right - hand torsion (e.g., a left - hand helix).

[0600] Similarly, referring to the left - hand rule (see Fig. 3O), a space curve that points in the direction of the left - hand binormal can be regarded as having a positive left - hand torsion (e.g., a left - hand helix). Thus, the positive direction of the left - hand corresponds to the negative direction of the right - hand. Refer to Fig. 3T. 5.9.6.4 Hole

[0601] A surface can have one - dimensional holes (e.g., holes bounded by a planar curve or a space curve). In the case of a thin - walled structure (e.g., a membrane) that contains holes, this structure can be described as having one - dimensional holes. For example, refer to the state where the one - dimensional holes in the surface of the structure shown in Fig. 3I are bounded by a planar curve.

[0602] The structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion of FIG. 3L and the exemplary cross-sections of FIG. 3L in FIGS. 3M and 3N showing the inner surface bounding the two-dimensional hole. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and may include a two-dimensional hole bounded by the inner surface of the conduit. Also see the two-dimensional hole bounded by a surface as shown through the structure of FIG. 3K and as illustrated. 5.10 Other Notes

[0603] Part of the disclosure of this patent document contains content that is given copyright protection. The copyright owner has no objection if someone reproduces this patent document or this patent disclosure by fax, provided it is for the purpose of what is described in the patent file or record of the Patent Office, but retains all copyrights for other purposes.

[0604] Unless otherwise clearly apparent from the context and unless a range of values is provided, it is understood that each intervening value between the lower limit of one-tenth of the unit of the lower limit, between the upper and lower limits of the range, and any other recited value or intervening value in the recited range of the technology is encompassed by the technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limits in the recited range, they are encompassed by the technology. If the recited range includes one or both of these limits, ranges exceeding either or both of these recited limits are also encompassed by the technology.

[0605] Furthermore, when a value (singular or plural) is embodied as part of the technology herein, unless otherwise specified, it is understood that such a value may be approximated and such a value may be used to any appropriate significant digit to the extent permitted or required by practical technical implementation.

[0606] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present technology, only a limited number of exemplary methods and materials are described herein.

[0607] Although specific materials are described as being preferably used in the construction of components, obvious alternative materials with similar properties can be used as substitutes. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and can thus be manufactured either collectively or individually.

[0608] As used herein and in the appended claims, note that the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0609] All publications described herein are hereby incorporated by reference for the disclosure and description of the methods and / or materials for which they are the subject. The publications described herein are provided only for their disclosure prior to the filing date of the present application. Nothing in this specification should be construed as an admission that the present technology does not antedate such publications by virtue of prior invention. Further, the dates of publication of the described publications may be different from the actual publication dates and may need to be individually verified.

[0610] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the recited elements, components, or steps can be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0611] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the claims. These headings should not be used in the interpretation of the claims or the scope of the limitations of the claims.

[0612] Although the techniques in this specification have been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are unnecessary for the implementation of the technology. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, the process steps in this method may be described or illustrated in an ordered manner, but such an order is not necessary. One skilled in the art will recognize that such an order can be changed and / or that the actions can be performed simultaneously or even more synchronously.

[0613] As used in this specification, the term "non-transitory computer-readable storage medium" includes the following: registers, cache memory, ROM, semiconductor memory devices (e.g., D-RAM, S-RAM, or other RAM), magnetic media (e.g., flash memory, hard disk, magneto-optical media), optical media (e.g., CD-ROM, DVD, or Blu-ray disk), or other types of devices for non-transitory electronic data storage. The term "non-transitory computer-readable storage medium" does not include transient, propagating electromagnetic signals.

[0614] Although specific examples have been described in relation to a CPAP system, it should be understood that the techniques in this specification may also be applicable to other types of home medical devices.

[0615] Therefore, it should be understood that numerous variations are possible in the exemplary embodiments without departing from the spirit and scope of the present technology, and other arrangements can be devised.

Explanation of Reference Signs

[0616] 5.11 List of Reference Signs 120 Display Screen 122 Display Screen 124 Display Screen 126 Display Screen 128 Display Screen 130 Display Screen 132 Display Screen 134 Display Screen 136 Display Screen 140 Display Screen 200 Display Screen 202 Display Screen 204 Display Screen 206 Display Screen 208 Display Screen 210 Display Screen 238 Display Screen 302 Display Screen 304 Display Screen 306 Display Screen 600 Computing Device 602 Processing System 604 System Bus 606 Memory Device 610 Input Adapter 612 Input Device 614 Display Interface 616 Display Device 618 Network Interface Device 620 Database 622 External Resource 630 Camera 632 IR Emitter 1000 Patient 1002 Patient 1004 Patient 1100 Roommate 3000 Patient Interface 3002 Strap 3004 Connector 3006 Indicator 3100 Seal Formation Structure 3200 Pleural Chamber 3210 Tendon 3220 Upper Point 3230 Lower Point 3300 Stabilization Structure 3302 Expandable Portion 3310 Tube 3320 Tube 3330 First Strap 3340 Second Strap 3350 Indicator 3360 Reference Point 3362 Reference Marker 3400 Ventilation Port 3600 Connection Port 3700 Forehead Support 3800 Non-Seal Type Patient Interface 4000 RPT Device 4010 External Housing 4012 Upper Part 4014 Portion 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet Air Filter 4120 Muffler 4122 Inlet Muffler 4124 Outlet Muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-Spillback Valve 4170 Air Circuit 4171 Air Circuit 4180 Make-Up Gas 4200 Electrical Components 4202 PCBA 4210 Power Supply 4220 Input Device 4230 Central Controller 4232 Clock 4240 Therapy Device Controller 4250 Protection Circuit 4260 Memory 4270 Converter 4272 Pressure Sensor 4274 Flow Sensor 4276 Motor Speed Converter 4280 Data Communication Interface 4282 Remote External Communication Network 4284 Local External Communication Network 4286 Remote External Device 4288 Local External Device 4290 Output Device 4292 Display Driver 4294 Display 4300 Algorithm 4310 Preprocessing Module 4312 Interface Pressure Estimation Algorithm 4314 Ventilation Flow Estimation Algorithm 4316 Leakage Flow Estimation Algorithm 4318 Respiratory Flow Estimation Algorithm 4320 Therapy Engine Module 4321 Phase Determination Algorithm 4322 Waveform Determination Algorithm 4323 Ventilation Determination Algorithm 4324 Inspiratory Flow Limitation Determination Algorithm 4325 Apnea / Hypopnea Determination Algorithm 4326 Snoring Determination Algorithm 4326 Snoring Determination 4327 Airway Patency Determination Algorithm 4328 Target Ventilation Determination Algorithm 4329 Treatment Parameter Determination Algorithm 4329 Treatment Parameter Determination 4330 Treatment Control Module 4340 Algorithm 4500 Method 4520 Step 4530 Step 4540 Step 4550 Step 4560 Step 5000 Humidifier 5002 Humidifier Inlet 5004 Humidifier Outlet 5006 Humidifier Base 5110 Reservoir 5120 Conductive Part 5130 Humidifier Reservoir Dock 5135 Lock Lever 5150 Water Level Indicator 5210 Humidifier Converter 5210 Humidifier Converter Sensor 5212 Air Pressure Sensor 5214 Flow Converter 5216 Temperature Converter 5218 Humidity Sensor 5240 Heating Element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating Element Controller 5254 Air Circuit Controller 6020 Communication Link 6030 Server 6040 Cloud Computing Platform 6062 Medical Device 6064 Medical Device 6514 Display Interface 6910 Step 6912 Step 6914 Step 7012 Step 7014 Step 7016 step 7018 step 7020 step 7022 step 7024 step 7026 step 7030 step 3810a nose prong 3810b nose prong 3820a air supply lumen 3820b air supply lumen

Claims

1. A display device; A camera and Memory and a processing system including at least one hardware processor and the memory; A device comprising: The processing system includes: capturing one or more images including the patient with a camera; based on the captured one or more images including the patient, transmitting data based on at least a portion of the one or more images to a remote processing system for analysis; After transmitting the data to the remote processing system, receiving from the remote processing system data for adjusting one or more settings of a patient interface configured to engage at least one airway of the patient and to deliver breathable gas received from a continuous positive air pressure (CPAP) device to the patient based on characteristics of the patient's facial features determined from the one or more images; and displaying instructions on the display device for adjusting one or more settings of the patient interface based on the received data about one or more settings of the patient interface; A device configured to:

2. The device described in claim 1, wherein the processing system is further configured to determine characteristics of the patient's facial features from the captured image.

3. A device as described in claim 1 or 2, wherein the transmitted data includes characteristics of the determined patient's facial features.

4. The processing system includes: receiving a user input specifying a type of the patient interface; and The device of claim 1 , further configured to transmit the patient interface type to the remote processing system for analysis.

5. The processing system includes: receiving one or more second images from the camera including the patient with the patient interface; analyzing the received one or more second images to determine a fit of the patient interface on a patient; and 10. The device of claim 1, further configured to: display feedback on the display device for improving the fit of the patient interface on the patient based on the analysis and the received data about the one or more settings of the patient interface.

6. The device of claim 5 , wherein the analyzing comprises comparing the received one or more second images to one or more reference images.

7. The device of claim 6 , wherein the one or more reference images include the patient wearing the patient interface.

8. 8. The device of claim 6 or 7, wherein the one or more reference images include a plurality of reference points, and the analysis includes detecting reference points in the received one or more second images and comparing the detected reference points with the plurality of reference points in the one or more reference images.

9. The device of any one of claims 5 to 8, wherein the analysis comprises extracting from the received one or more second images one or more indicators included on the patient interface.

10. The device of claim 9 , wherein the one or more indicators comprise a plurality of indicators provided on one or more straps of the patient interface.

11. 11. The device of claim 9 or 10, wherein the one or more indicators include at least one indicator provided on a mask of the patient interface.

12. 12. The device of claim 9 or 11, wherein the one or more indicators include an indicator provided on a connector configured to connect at least one of the straps to a mask of the patient interface.

13. 13. The device of claim 9 or 12, wherein the processing system is further configured to determine a force applied from one or more straps based on characteristics of the one or more indicators in the one or more second images.

14. 14. The device of claim 9 or 13, wherein the processing system is further configured to compare forces applied from different straps of the patient interface based on characteristics of the one or more indicators included within the different straps.

15. 15. The device of claim 9 or 14, wherein the processing system is further configured to indicate that one or more straps are too tight based on a characteristic of the one or more indicators in the one or more straps.

16. 10. The device of claim 1, wherein the analysis performed by the remote processing system includes comparing the one or more images to a model generated based on information received from a plurality of other patients.

17. A non-transitory computer-readable storage medium storing instructions for use with a computing device to assist in the application of a patient interface configured to engage at least one airway of a patient and deliver breathable gas received from a continuous positive air pressure (CPAP) device to the patient, comprising: The stored instructions may cause the computing device to: receiving, via the camera, one or more images including the patient; based on one or more images including the patient, transmitting data based at least in part on the one or more images to a remote processing system for analysis; after transmitting data to the remote processing system, receiving data from the remote processing system for adjusting one or more settings of the patient interface based on characteristics of facial features determined from the one or more images; and causing a display device to output instructions, the instructions including adjusting one or more settings of the patient interface based on the received data for one or more settings of the patient interface; A non-transitory computer-readable storage medium comprising instructions configured to cause

Images