Two-way communication in medical devices

Abstract

To provide a system for providing continuous positive pressure therapy.SOLUTION: The system includes a flow generator, a sensor, and a computing device. The computing device is configured to control operation of the flow generator based on sensor data. A display device is further configured to: display, on a display device, one or more questions relating to demographic and / or subjective feedback; in response to displaying the one or more questions, receive one or more inputs indicating answers to the one or more questions; transmit the answers to a remote processing system; receive, from the remote processing system, settings determined; and adjust control settings based on the received settings.SELECTED DRAWING: Figure 4G

Description

Technical Field

[0001] 1 Cross-reference to Related Applications This application claims priority to U.S. Provisional Application No. 62 / 848,991, filed on Mar. 16, 2019, and the above application is hereby incorporated by reference in its entirety for all purposes.

[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 ameliorating respiratory-related diseases. This technology also relates to medical devices or apparatuses and their use. More specifically, this technology relates to methods and systems for setting up medical devices and providing personalized coaching and / or customized treatment for patients using medical devices.

Background Art

[0003] 2.2 Description of Related Technologies 2.2.1 The Human Respiratory System and Its Diseases The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0004] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they proceed deeper into the lungs. The primary function of the lungs is gas exchange, which takes in oxygen from the air into venous blood and expels carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is referred to as the respiratory region. See the following: “Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] A range of respiratory diseases exist. Certain diseases can be characterized by specific onsets (e.g., apnea, respiratory depression, and hyperventilation).

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the onset of closure or obstruction of the upper airway during sleep. This results from a combination of an abnormally small upper airway, normal loss of muscle tone in the tongue region, and normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of this condition, respiratory cessation in affected individuals typically lasts 30 to 120 seconds, sometimes as many as 200 to 300 times a night. Consequently, excessive daytime sleepiness occurs, which can lead to cardiovascular disease and brain injury. This condition is common, particularly prevalent in overweight middle-aged men, although patients often have no subjective symptoms. See U.S. Patent No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to recurrent hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep-wake cycles, which cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following conditions:

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

[0011] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to air movement, prolonged expiratory phase of respiration, and reduced normal elasticity in the lungs. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational radiation exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0013] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage, which can lead to inability to walk, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slowly progressive types: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over several months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over several years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increased general weakness, dysphagia, dyspnea at exertion and rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0014] Chest wall disorders are a group of thoracic deformities that cause dysfunction in the connection between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can develop into severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments are used to treat or improve such conditions. Furthermore, otherwise healthy individuals can also take advantage of preventive treatments for respiratory diseases. However, these have several drawbacks.

[0016] 2.2.2 Treatment A variety of therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV)) are used to treat one or more of the respiratory diseases mentioned above.

[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, allowing CPAP to function as an air splint, thereby preventing upper airway obstruction. Since CPAP treatment for OSA can be voluntary, patients may choose not to adhere to treatment if they notice one or more of the following regarding the device used to deliver the treatment: discomfort, difficulty of use, high cost, or lack of aesthetic appeal.

[0018] Non-invasive ventilation (NIV) provides ventilatory support to the patient through the upper airway to assist with breathing and / or maintain adequate oxygen levels throughout the body by performing some or all of the respiratory function. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0019] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] 2.2.3 Treatment System These treatments may be provided by treatment systems or devices. Such systems and devices may also be used for screening, diagnosing, or monitoring diseases without treating them.

[0021] The treatment system may include a respiratory pressure therapy device (RPT device), air circuitry, humidifier, patient interface, and data management.

[0022] 2.2.3.1 Patient Interface A patient interface may be used to provide the wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway inlet. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface may form a seal with, for example, the area of ​​the patient's face, thereby facilitating gas delivery at a pressure of sufficient dispersion along with the ambient pressure for the administration of the therapy (for example, at a positive pressure of about 10 cmH2O relative to the ambient pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas to the airway at a positive pressure of about 10 cmH2O.

[0023] In the design of patient interfaces, there are multiple challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly among individuals. Since the head includes 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 treatment period.

[0024] Due to these challenges, in some cases of 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.

[0025] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient has consented to the treatment. If the mask is uncomfortable, the wrong size, difficult to use, unsuitable for specific patient characteristics (e.g., a nasal mask for a mouth breather), or difficult to clean (e.g., difficult to assemble or disassemble), the patient may not comply with the treatment.

[0026] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device The Respiratory Pressure Therapy (RPT) device can be used individually for the delivery of one or more of the above-mentioned treatments or as part of a system, for example, by operating the device to generate an air delivery flow to the interface to the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0027] Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that cannot be met by more general pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0028] An RPT device typically includes a pressure generator (e.g., an electric blower or compressed gas reservoir) and is configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface as described above via an air circuit.

[0029] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may be far removed from convention, or even unavoidable. Furthermore, the comfort and effectiveness of a particular design can be significantly affected by even minor changes in one or more parameters.

[0030] 2.2.3.3 Humidifier Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, adding warm air to the facial area around the patient interface generally provides greater comfort than cool air.

[0031] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (for example, whether the patient is using their RPT device in accordance with one or more "compliance rules"). For example, a compliance rule for CPAP therapy might require a patient to use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, an RPT device provider (e.g., a healthcare provider) may manually collect data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify third parties that the patient is compliant.

[0032] In patient treatment, there may be other ways in which communication of treatment data to third parties or external systems may be beneficial.

[0033] Existing processes for communicating and managing such data can be costly, time-consuming, and prone to errors. [Overview of the project] [Means for solving the problem]

[0034] 3. A brief explanation of the technology This technology relates to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, which have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0035] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory diseases.

[0036] Another aspect of this technology relates to a method used in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0037] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0038] A respiratory pressure therapy system included in one embodiment of this technology is configured to present demographic and / or subjective questions to the patient, receive answers to these questions, and analyze these questions for determining the settings of the respiratory pressure therapy system.

[0039] Another aspect of one form of this technology is to determine a personalized coaching program and / or tailor-made treatment for a patient (e.g., through advanced analysis) based on the patient's responses to demographic and / or subjective questions and / or data from multiple other users.

[0040] One form of this technology involves applying settings to a respiratory pressure therapy system based on demographic and / or subjective questions answered by the patient.

[0041] Another aspect of one form of this technology involves presenting demographic and / or subjective questions and receiving responses via a web application or mobile application.

[0042] Another aspect of one form of this technology involves receiving responses to demographic and / or subjective questions via a web or mobile application and using those responses to determine the settings of a respiratory pressure therapy system.

[0043] Another aspect of one form of this technology is a processing system and a computing system. The processing system includes a memory for storing a plurality of demographic questions and / or a plurality of objective questions. The computing system is configured to: transmit demographic and / or objective questions to a medical device and / or a mobile device configured to run an application for communication with the medical device; receive answers to the questions from the medical device and / or the mobile device; and, based on the received answers, determine a personalized coaching program and / or a customized treatment using the medical device for the patient, for example, through advanced analysis.

[0044] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has limited experience using this type of medical device.

[0045] Another aspect of the present technology relates to a respiratory pressure therapy (RPT) system for providing continuous positive pressure (CPAP) to a patient. The system includes: a flow generator configured to produce a supply of breathable gas to be delivered to a patient, the breathable gas being output from the flow generator at a pressure level above atmospheric pressure; at least one sensor configured to measure physical quantities while the breathable gas is being delivered to the patient; and a computing device including memory and at least one hardware processor. The computing device may be configured to: receive sensor data from at least one sensor based on the measured physical characteristics of the breathable gas supply; control the flow generator based on the received sensor data to adjust the characteristics of the breathable gas supply delivered to the patient; display one or more questions relating to demographic and / or subjective feedback on a display device; receive one or more inputs indicating answers to one or more questions in response to the display of one or more questions; transmit the answers to a remote processing system; receive settings for the respiratory pressure therapy system determined based on the transmitted answers from the remote processing system; and adjust the control settings for the respiratory pressure therapy system based on the received settings.

[0046] In the example, (a) the remote processing system may be an on-demand cloud computing platform configured to perform machine learning using data received from multiple patients, (b) the questions may be pre-stored in memory, (c) the computing device may be further configured to perform setup operations, one or more questions may be displayed after setup and after certain conditions are met, (d) the conditions may include a certain period of time that elapses after setup, (e) the questions may include at least one question relating to demographic information about the patient and at least one question relating to subjective feedback from the patient regarding the use of the respiratory pressure therapy system, and (f) the system may further include a remote processing system, the remote processing system is remote (g) the system may be configured to determine a personalized coaching program for the patient based on responses sent to a remote processing system, the remote processing system may be configured to determine a personalized treatment for the patient based on responses sent to the remote processing system, (h) one or more questions may be received from the remote processing system, (i) the system may further include a patient interface configured to engage with at least one airway of the patient and the supply of breathable gas to the patient, and / or (j) the setting of the respiratory pressure therapy system and / or the receipt of a personalized coaching program may be done by an application, website, email, and / or a mobile device associated with the patient.

[0047] Another aspect of this technology relates to an apparatus for the treatment of respiratory distress in patients. The apparatus includes: a display device; a pressure generator configured to produce an airflow for the treatment of respiratory distress; a transducer configured to produce a flow signal indicating the characteristics of the airflow; and a controller connected to the display, pressure generator, and transducer. The controller may be configured to: receive a flow signal from the transducer; control the pressure generator to adjust the characteristics of the airflow based on the received flow signal; display a request for demographic and / or subjective feedback on the display device; receive one or more inputs indicating demographic and / or subjective feedback in response to a request; transmit demographic and / or subjective feedback data determined based on the received one or more inputs to a remote processing system; receive analysis results determined based on the transmitted demographic and / or subjective feedback data from the remote processing system; and adjust the control settings of the apparatus based on the received analysis results.

[0048] In the example, (a) the controller, display, and pressure generator may be housed together; (b) the adjusted control settings may include therapeutic pressure delivered in a patient mask connected to the pressure generator; (c) the analysis results may include a personalized coaching program for the patient; (d) the analysis results may include a tailored treatment for the patient; (e) the controller may be configured to transmit device operation data along with demographic and / or subjective feedback data; the analysis results may be determined based on demographic and / or subjective feedback data as well as device operation data; (f) requests for demographic and / or subjective feedback may be displayed after certain conditions are met; (g) the conditions may be a predetermined period after the device is set up, and / or (h) the conditions may be a predetermined period during which the device is operated by the patient.

[0049] Another aspect of the present technology relates to a method for operating a respiratory therapy device that generates airflow for the treatment of respiratory disorders. The method includes measuring the characteristics of the airflow using a transducer; calculating an outcome in a controller based on the measured characteristics, including at least one of respiratory events, the patient's cardiac respiratory characteristics, and the patient's physical condition; controlling the adjustment of the airflow characteristics in the controller based on the outcome; displaying one or more questions related to demographic and / or subjective feedback; receiving one or more inputs in the controller indicating answers to one or more questions in response to the display of one or more questions; transmitting the answers to a remote processing system; and receiving settings from the remote processing system for the operation of the respiratory therapy device and / or a personalized coaching program for the patient based on the answers transmitted to the remote processing system.

[0050] In the example, (a) the method may include adjusting the control settings of the respiratory therapy device based on the received settings; (b) the settings for operating the respiratory therapy device may provide the patient with personalized treatment determined based on the response sent to a remote processing system upon receipt of an input indicating the response and the control settings of the respiratory therapy device; (c) the question may be displayed on the display of the respiratory therapy device; (d) the question may be displayed on a mobile device configured to run an application for controlling the respiratory therapy device; (e) the question may be displayed after certain conditions are met; (f) the conditions may be a predetermined period of time after the respiratory therapy device has been set up and / or (g) the conditions may be a predetermined period of time during which the respiratory therapy device has been operated by the patient.

[0051] Another aspect of the present technology relates to a processing system including: a memory for storing a plurality of demographic questions and a plurality of objective questions; a computing system including at least one hardware processor connected to the memory, the computing system configured to: transmit at least one demographic question and at least one objective question stored in the memory to a medical device associated with a patient; receive from the medical device answers to the at least one demographic question and at least one objective question transmitted to the medical device; send a notification to a mobile device configured to run an application for communication with the medical device that there are unanswered questions; receive a request for questions from the mobile device; in response to the request, transmit at least one demographic question and at least one objective question stored in the memory to the mobile device; receive from the mobile device answers to the at least one demographic question and at least one objective question transmitted to the mobile device; and perform advanced analysis to determine a personalized coaching program and a customized treatment using medical devices for a patient based on (1) answers received from the medical device and the mobile device and (2) answers received from a plurality of other medical devices.

[0052] In the example, (a) the computing system may be further configured to receive from the medical device answers to questions that have been pre-stored on the medical device and answered using the medical device; (b) the medical device may be a respiratory therapy device; (c) the questions may be transmitted to a mobile device and / or the medical device after certain conditions have been met; (d) the conditions may be a predetermined period of time after the medical device has been set up; and / or (e) the conditions may be a predetermined period of time during which the medical device has been operated by a patient. The methods, systems, devices and apparatus described may be embodied in a way that enables improvements in the functionality of a processor (e.g., the processor of a computer for a specific purpose, the functionality of a respiratory monitor and / or respiratory therapy device). Furthermore, the methods, systems, devices and apparatus described may enable improvements in the field of the automated management, monitoring and / or treatment of respiratory conditions (e.g., sleep-disordered breathing).

[0053] Of course, some of the above embodiments may form sub-embodiments of the present technology. Furthermore, various combinations of sub-embodiments and / or various other embodiments may constitute even further embodiments or sub-embodiments of the present technology.

[0054] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0055] 4. Brief Description of the Drawings This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements: [Brief explanation of the drawing]

[0056] 4.1 Treatment System [Figure 1]The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal pillow and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels to patient 1000 along an air circuit 4170. A bedmate 1100 is also illustrated. The patient is sleeping in a supine position. [Figure 2] The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal mask and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. [Figure 3] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 removes a full face mask and receives positive pressure air from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 4.2 RPT device [Figure 4A] This shows an RPT device based on one form of this technology. [Figure 4B] This is a schematic diagram of the air circuit of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with respect to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items placed in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] This is a schematic diagram of the electrical components of an RPT device according to one embodiment of this technology. [Figure 4D] This is a schematic diagram of the electrical components of an RPT device according to one embodiment of this technology. [Figure 4E]This is a schematic diagram of an algorithm executed in an RPT device, representing one form of this technology. [Figure 4F] This is a flowchart illustrating a method implemented by the treatment engine module shown in Figure 4E, according to one aspect of this technology. [Figure 4G] This is a diagram of a communication system between an RPT device and a remote computing system, based on one embodiment of this technology. [Figure 4H] This document illustrates an exemplary operation performed by an RPT device and remote computing system using one embodiment of this technology. [Figure 4I] An exemplary display screen, including demographic requests and / or subjective feedback requests, that may be displayed to a patient, is shown, based on one embodiment of this technology. [Figure 4J] This is another example of the operation performed by an RPT device and remote computing system using one form of this technology. [Figure 4K] This is a data flow diagram for a system that provides communication between a medical device, a patient portal 8030, and a patient statistics survey service 8010, using one form of this technology. 4.3 Humidifier [Figure 5A] This shows an isometric view of a humidifier based on one form of this technology. [Figure 5B] This figure shows an isometric view of a humidifier according to one embodiment of this technology, illustrating the humidifier reservoir 5110 being removed from the humidifier reservoir dock 5130. [Figure 5C] This is a schematic diagram of a humidifier based on one form of this technology. [Modes for carrying out the invention]

[0057] 5. Detailed Description of Examples of the Technology Before describing the technology in further detail, it should be understood that the technology is not limited to the specific embodiments which may differ as described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0058] The following description is provided in relation to a variety of embodiments that may share one or more common properties and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or any other embodiment. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0059] 5.1 Treatment In one embodiment, the technology includes a method for treating respiratory diseases. The method includes the step of applying positive pressure to the airway entrance of 1000 patients.

[0060] In certain embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0061] In certain embodiments of this technology, mouth breathing is restricted, limited, or prevented.

[0062] 5.2 Treatment System In one embodiment, the technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0063] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of this technology includes one or more functional modes of a seal-forming structure, a plenum chamber, a positioning and stabilizing structure, a vent, a form of connection port for connection to an air circuit 4170, and a forehead support. In some embodiments, the functional modes may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the seal-forming structure is positioned to surround the entrance to the patient's airway to facilitate positive pressure air supply to the airway.

[0064] If a patient interface cannot comfortably deliver the minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0065] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply at any positive pressure between at least 4 cmH2O, at least 6 cmH2O, at least 10 cmH2O, at least 20 cmH2O, at least 30 cmH2O, and at least 4 cmH2O to 30 cmH2O relative to the surroundings.

[0066] 5.4 RPT Devices An RPT device 4000 according to one aspect of this technology includes mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms 4300 (e.g., any of the methods described herein, either entirely or in part). The RPT device 4000 may be configured to generate an airflow delivered to a patient's airway for the treatment of one or more respiratory conditions described in any of the sections herein.

[0067] In one embodiment, the RPT device 4000 is constructed and positioned to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, at least 10 cmH2O, or at least 20 cmH2O.

[0068] 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. Furthermore, 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.

[0069] The pneumatic path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying air at positive pressure (e.g., a blower 4142 including a motor 4144), an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0070] One or more of the air passage items may be housed within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be housed within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0071] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative configuration, the RPT device 4000 may include more than one PCBA 4202.

[0072] An RPT device may include one or more of the following components in a single unit. In one alternative configuration, one or more of the following components may be arranged as separate units. For example, an RPT device may include one or more of the following: an air filter 4110, a side panel, a muffler (e.g., muffler 4120, inlet muffler 4122, outlet muffler 4124), a pressure generator, a pneumatic block, a chassis, a transducer 4270 (flow transducer, pressure transducer, motor speed transducer), an optical sensor, an anti-spillback valve 4160, an air circuit, an air circuit connector, an oxygen delivery port, a power supply, a central controller, a therapeutic device controller, a protection circuit, a data connection interface, memory, an output device (e.g., a display, an alarm), and a user interface panel (one or more) (e.g., as described in PCT application PCT / AU2014 / 050426 (WO2015089582)) (the said document is incorporated herein by reference).

[0073] For example, the user interface panel 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 may be physical or software devices accessible via a touchscreen. In one form, the buttons, switches, or dials may be physically connected to an external housing 4010, or in another form, they may be wirelessly connected to a receiver electrically connected to a central controller 4230.

[0074] In one embodiment, the input device 4220 may be constructed and configured to allow a human to select a value and / or a menu option.

[0075] 5.4.1.1 Data Communication System In one embodiment of this technology, a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 may be 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.

[0076] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0077] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0078] In one embodiment, the local external communication network 4284 uses one or more communication standards (e.g., Bluetooth® or Consumer Infrared Protocol).

[0079] In one embodiment, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In another embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by a properly authorized person (e.g., a clinician).

[0080] The local external device 4288 may be a personal computer, mobile phone, tablet, or remote control.

[0081] 5.4.1.2 Optional output devices including displays and alarms The output device 4290 according to this technology may take the form of one or more of visual, auditory, and haptic units. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0082] 5.4.1.2.1 Display Driver The display driver 4292 receives characters, symbols, or images to be displayed on the display 4294 as input and converts them into commands to display these characters, symbols, or images on the display 4294.

[0083] 5.4.1.2.2 Display The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an 8-segment display, in which case the display driver 4292 translates each character or symbol (e.g., the digit "0") into eight logical signals indicating whether each of the eight segments should be activated to display a particular character or symbol.

[0084] 5.4.2 RPT Device Algorithm As described above, in some forms of this technology, the central controller 4230 may be configured to embody one or more algorithms 4300 expressed as computer programs recorded in a non-temporary computer-readable recording medium (e.g., memory 4260). These algorithms 4300 are typically grouped into groups called modules. A module may include a pre-processing module 4310 that provides pressure compensation 4312, airflow estimation 4314, leakage flow estimation 4316, and respiratory flow estimation 4318. The processing of the pre-processing module 4310 may be used as input to the therapeutic engine module 4320. The therapeutic engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / depressive reduction determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapeutic parameter determination 4329. The treatment control module 4330 receives treatment parameters from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 as input and controls the pressure generator 4140 to deliver airflow from the pressure generator 4140 according to these treatment parameters. In one embodiment of this technology, the central controller 4230 performs one or more methods 4340 for detecting fault conditions. Details of one or more operations performed by the algorithm are described in PCT application PCT / AU2014 / 050426 (WO2015089582), which is incorporated herein by reference.

[0085] 5.5 Air Circuit An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and positioned so that airflow moves between two components (e.g., an RPT device 4000 and a patient interface 3000) during use.

[0086] In detail, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be called an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0087] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (for example, to maintain or raise the air temperature). The heating elements may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may communicate with a controller (e.g., a central controller 4230). One embodiment of the air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0088] 5.6 Two-way communication for personalized therapy and / or coaching In one form of this technology, a medical device (e.g., an RPT device) may include bidirectional communication with one or more remote processing systems to facilitate personalized coaching programs, tailored treatments, and / or targeted care. The medical device may be configured to capture data and / or transmit data to the remote processing system for processing. Captured data may include sensor data, demographic feedback, and / or subjective feedback. The remote processing system may use the received data to perform patient segmentation and / or advanced analysis and provide personalized solutions to the medical device. Examples of these personalized solutions include personalized coaching programs to improve engagement and motivation, tailored treatments including comfort through automation and / or treatment setting updates to improve long-term adherence, and / or targeted care and follow-up based on identifying patients who need assistance. Patient segmentation and advanced analysis may include performing machine deep learning using data from other users and one or more trained models to provide personalized solutions.

[0089] In contrast to conventional systems that require pre-loading of medical device settings and require highly trained technicians to change settings, this technology allows medical devices to be automatically configured after they are deployed for use. Precise and rapid remote determination of medical device settings and patient recommendations can be made, eliminating the need for clinicians to repeatedly change device settings (until the patient feels comfortable using the medical device). Furthermore, feedback received from user and medical device settings can be used to improve the settings of other medical devices and provide relevant recommendations to other patients.

[0090] Figure 4G is a diagram of a communication system between an RPT device 4000 and a remote computing system. Figure 4G includes one or more RPT devices 4000 associated with a patient 1000. This technology is not limited to RPT devices and may be applied to other medical devices. The RPT device 4000 may be configured to communicate with a remote external device 4286 and / or a local external device 4288 (e.g., a personal computer, mobile phone, tablet and / or remote control) and / or a remote external device via a data communication interface 4280. The local external device 4288 may be configured to communicate directly with the RPT device 4000 (if located in the vicinity of the RPT device 4000) or may be configured to communicate remotely via a local or external network (if the local external device 4288 is not located in the vicinity of the RPT device 4000). The remote external device 4286 may be accessible to appropriately authorized persons (e.g., clinicians, manufacturers and / or device suppliers). As shown in Figure 4G, the RPT device 4000 can also communicate with remote computing systems, including the server 6030 and / or the cloud computing platform 6040 (e.g., Amazon Web Services®, Google Cloud Platform, Microsoft Azure).

[0091] One or more other medical devices 6062 or 6064 (which may be RPT devices) may be associated with other patients 1002 and 1004 and configured to communicate with a remote external device 4286, a server 6030 and / or a cloud computing platform 6040.

[0092] The devices shown in Figure 4G may communicate via a communication link 6020 that includes a remote external communication network 4282 and / or a local external communication network 4284.

[0093] The RPT device 4000 and / or medical devices 6062 and 6064 may be configured to communicate sensor data, demographic feedback, and / or subjective feedback to the server 6030 and / or cloud computing platform 6040 via the communication link 6020. The server 6030 and / or cloud computing platform 6040 may be configured to use the received data to perform patient segmentation and / or advanced analysis and to provide personalized solutions to the RPT device. These personalized solutions may include personalized coaching programs, tailored treatments, and / or targeted care.

[0094] Figure 4H illustrates exemplary operation performed by the RPT device 4000 and the remote computing system according to one embodiment of this technology. While Figure 4 shows operations performed by specific devices, these operations are not limited to these. One or more operations may be performed by other devices operationally connected to the RPT device 4000 and / or the remote computing system. In some examples, one or more operations illustrated as being performed by the RPT device 4000 may be performed using a web application or a mobile application running on another device (e.g., local external device 4288).

[0095] The RPT device 4000 may be configured to perform the setup of the RPT device 4000 (step 7010). This setup may include associating the patient with the RPT device 4000, configuring the initial settings of the RPT device 4000 for the patient, and / or providing instructions on how to use the device. One or more of these operations are disclosed in U.S. Provisional Application No. 62 / 749,430 (filed October 23, 2018, title: "SYSTEMS AND METHODS FOR SETUP OF CPAP SYSTEMS") and U.S. Provisional Application No. 16 / 661,250 (filed October 23, 2019, title: "SYSTEMS AND METHODS FOR SETUP OF CPAP SYSTEMS"). These documents are incorporated herein by reference. One or more of these operations may be performed during the setup of the RPT device 4000.

[0096] Setup may be performed when the RPT device 4000 is powered on for the first time after purchase or reset, or when the RPT device 4000 is assigned to a new patient. Setup may be performed without user interaction by applying settings for the RPT device 4000 stored in memory (e.g., memory 4260 or external memory of the RPT device 4000) or by receiving instructions from a remote external device 5286 controlled by a clinician, manufacturer, and / or device distributor.

[0097] Patient input may be requested and received during setup from the RPT device 4000 and / or other devices. In some examples, instructions and / or questions may be provided using the output device 4290, and patient input may be received using the input device 4220. In other examples, only the RPT device 4000 may be used to receive input during setup. In other examples, a local external device 4288 may be used instead of or in addition to the RPT device 4000 to receive user input for the setup of the RPT device 4000. During device setup, a display screen may be generated on the RPT device 4000 and / or the external device to request patient input. In some examples, voice instructions and / or audible responses may be received by the RPT device 4000 and / or the local external device 4288. In some cases, data entry for user and / or personalized coaching programs, tailored treatments and / or targeted care, and follow-up (e.g., provided in response to the entered data) may be delivered through a range of different mechanisms (e.g., applications, web, email, telephone).

[0098] The RPT device 4000 may operate based on the device settings made during setup (step 7012). During operation of the RPT device 4000, the device operation may be adjusted based on sensor data (e.g., flow sensor 4274, pressure sensor 4272, and / or velocity sensor 4276) and / or further settings received from the patient and / or clinician.

[0099] After one or more predetermined conditions are met, a feedback request may be displayed to the patient (step 7018). This feedback request may be displayed on the display 4294 or on the device and / or on a local external device 4288 (e.g., within an application). The feedback request may request demographic and subjective feedback from the user in the form of questions or instructions. The feedback request may be made automatically when the predetermined conditions are met. The feedback may not be limited to demographic and subjective feedback and may include further questions. The feedback, demographic and / or subjective feedback may include sleep study results, symptoms, comorbidities or other health information (e.g., presence of other sleep problems (e.g., insomnia)), level of knowledge about sleep apnea, level of comfort at the start of treatment, stage in the journey (first-time treatment user or already experienced user) and / or motivation.

[0100] Certain conditions include: a predetermined period of time elapsed after the RPT device 4000 has been set up; the patient reaching a specified goal (e.g., using the device over a predetermined period of time (e.g., a predetermined number of hours, days, or weeks)); using specific features suggested by the RPT device 4000 (e.g., operating the device in low-power mode for a predetermined number of times or for a predetermined period of time); completing the setup of the RPT device 4000; receiving a signal from a device operated by a remote computing system or clinician; receiving a feedback request from another device; setting a flag indicating that the feedback request is available for display to the patient; and / or receiving a notification that the feedback request is available for download.

[0101] In response to a feedback request, inputs indicating demographic and / or subjective feedback from the patient may be received (step 7020). These inputs may be received using only the RPT device 4000 (e.g., via input device 4220), only the local external device 4288, or both the RPT device 4000 and the local external device 4288.

[0102] Figure 4I shows an exemplary display screen including demographic feedback requests and / or subjective feedback requests that may be displayed to the patient. These feedback requests may be displayed on the display 4294 of the RPT device 4000 and / or on a display associated with the local external device 4288. In Figure 4I, the display screens are shown in a specific order, but the implementation is not limited thereto. One or more of the display screens may be in a different order, or not in this order. One or more other display screens may be in this order.

[0103] Introduction screens 7050 and 7052 may include introduction text, graphics, and / or images along with information for introducing the personalized features of the system, components, and / or treatment to the patient. Introduction screen 7050 may be displayed for a predetermined period of time before automatically transitioning to display screen 7052. Display screen 7052 may provide the user with the option to continue responding to the displayed feedback request or to skip the personalized features of the RPT device 4000. In some examples, the user may be offered the option to provide information later instead of, or in addition to, skipping the personalized features. The display of introduction screens 7050 and / or 7052 may occur only when the user first powers on the unit (e.g., after purchase or reset), or it may occur a predetermined number of times until customized information is received.

[0104] Display screen 7054 shows the patient the option to select their gender. As shown on display screen 7054, the patient may be offered the option to skip the feedback request. One or more of the other feedback requests may also include an option to skip the response request.

[0105] Display screen 7056 shows options for entering the patient's age. In other examples, the feedback request may include entering the patient's day, month, and / or year of birth.

[0106] Display screen 7058 shows options for entering the patient's height, and display screen 7060 shows options for entering the patient's weight.

[0107] Display screen 7062 presents a question regarding whether the patient has previously used the RPT device 4000. In some examples, the question may include providing several other RPT devices the patient has used or providing a predetermined scale indicating the level of expertise the patient believes they possess in using the RPT device 4000.

[0108] Display screen 7064 presents questions for assessing the amount of daytime sleepiness a patient typically experiences. Users may be assigned different scales between "not sleepy" and "very sleepy." Other subjective question feedback questions include sleep regularity, sleep satisfaction, sleep wakefulness, sleep timing, sleep efficiency, and / or sleep length. These questions may include: "Do you usually wake up at roughly the same time each day (within an hour)?", "How often do you get enough sleep?", "How often are you able to stay awake all day without napping or dozing off?", "Do you typically wake up for less than 39 minutes during your nighttime sleep between 2 a.m. and 4 a.m.?", and / or "Do you typically sleep 6 to 8 hours a day?". One or more responses to these questions may be assigned a sliding scale and / or multiple selectable responses (e.g., "rarely," "sometimes," and "always").

[0109] In one example of this technology, the feedback may include non-subjective feedback. The feedback may include apnea / hypopnea indices entered by the patient and / or retrieved from a database or from a physician or clinician.

[0110] Based on the feedback results, the patient may be assigned a sleep score, a coaching program, and / or personalized treatment. This information may be determined by the RPT device 4000 and / or other devices (e.g., the device shown in Figure 4G). The sleep score may be displayed to the patient and / or updated as feedback is regularly received from the patient.

[0111] Other feedback requests that may be included on other display screens include the level of sleep the patient got at night, the comfort level of the mask, the comfort level of breathing when using CPAP, and / or the satisfaction level with the device's operation. In some cases, subjective questions (e.g., sleep comfort) may be received multiple times over different periods. For example, the RPT device 4000 may be configured to ask the patient to provide feedback on sleep comfort over a given number of days (e.g., 7 days).

[0112] A feedback request screen may include an option to select that the response is unknown, and / or may provide an option to search for information from external sources (e.g., databases, physician records, external devices, etc.).

[0113] In some cases, a single feedback request may be displayed on the screen, or two or more feedback requests may be displayed simultaneously on a single screen. For example, requests to enter the patient's age and height may be displayed simultaneously on one screen.

[0114] In one embodiment of this technology, a display screen containing a feedback request may be displayed on a touch-input display. In one embodiment of this technology, input to a question displayed on the display may be input using one or more input devices 4220 (e.g., physical buttons, switches or dials, or software devices accessible via a touchscreen).

[0115] In one embodiment of this technology, a feedback request may be audibly output to the patient using a speaker, and / or a verbal feedback response may be captured via a microphone.

[0116] After responses to feedback requests are received, these responses may be stored in memory and / or sent to a remote computing system (step 7022). In one embodiment of this technology, data may be sent directly to an on-demand cloud computing platform (e.g., Amazon Web Services®, Google Cloud Platform, Microsoft Azure). These responses may include demographic and / or subjective feedback data. In one embodiment of this technology, if a connection to the remote computing system is unavailable, the feedback data may be stored in memory 4260 until a connection becomes available.

[0117] In step 7022, other data may be transmitted to the remote computing system along with the feedback data. For example, other data may include treatment data to determine whether the patient has used the RPT device in accordance with compliance regulations, identification information of the RPT device 4000 (e.g., serial number), location information of the RPT device 4000, user profile data, data captured by sensors (e.g., transducer 4270), settings applied during the setup of the RPT device 4000, the types of accessories connected to the PT device 4000, and / or setting changes made by the patient and / or when such changes were made.

[0118] The remote computing system receives data (step 7024), analyzes this data (step 7026), and sends the analysis results to the RPT device 4000 and / or a web application or mobile application (step 7028). The remote computing system may receive demographic and / or subjective feedback and other data from the RPT device 4000 or a local external device. This data may be received directly by the remote computing system for processing. The remote computing system may include a server 6030 and / or a cloud computing platform 6040. Server 6030 may be a non-cloud-based server managed by the manufacturer or clinician.

[0119] The remote computing system can subdivide patient data (e.g., age range, sex, weight, environment) and, using models developed with similar and / or different data from other users, determine what the patient needs and / or which settings of the RPT device 4000 need to be changed.

[0120] These models may be predefined by advanced analytics, artificial intelligence, and / or machine learning. The remote computing system may include models determined based on information about the operation of other RPT devices (e.g., medical devices 6062 and / or 6064) associated with other patients 1002 and / or 1004, and demographic and subjective feedback received from other patients 1002 and / or 1004. Advanced analytics, artificial intelligence, and / or machine learning may be performed on data from a large number of patients, and these models may be updated with new data as new data becomes available (e.g., data including demographic and subjective feedback, and / or changes to compliance standards). Examples of these analytical outcomes include personalized coaching programs, tailored treatments, and / or targeted care and follow-up.

[0121] In response to the transmission of feedback data, the RPT device 4000 may receive analysis results from a remote computing system (step 7030). These analysis results may include personalized coaching programs, tailored treatments, and / or targeted care and follow-up.

[0122] These personalized coaching programs may be offered to improve patient engagement and motivation. These personalized coaching programs may include instructions on the proper use of the device, explain the benefits of using the features provided by the device, and / or suggest other medical devices and / or accessories that may be useful to the patient. For example, information about accessories that improve the patient's experience using the RPT device 4000 (e.g., different types of masks) may be displayed on the display 4294 or the local external device 4288.

[0123] Personalized treatment can provide automated comfort settings (which have been shown to improve long-term adherence (LTA)). Personalized treatment can be automatically applied to the RPT device 4000 without patient interaction. In some cases, patients may be given information about treatment changes and may be asked to accept the proposed changes (before application).

[0124] Targeted care and follow-up may include notifying patients in need of care changes or scheduling appointments with clinicians or other specialists. In some cases, the RPT device 4000 and / or local external device 4288 may be used to schedule and / or conduct appointments with clinicians or other specialists.

[0125] These analysis results may be used to adjust the settings of the RPT device 4000 (step 7032). Changing the settings may include adjusting one or more comfort settings of the RPT device 4000. For example, these analysis results may include instructions to change the pressure gradient setting, exhalation relief setting, humidity setting, and air temperature setting. In one embodiment of this technology, the analysis results may indicate that the continued use of the RPT device 4000 is unsafe and therefore the use of the RPT device 4000 may be disabled.

[0126] After applying these analysis results, the operation of the RPT device 4000 may continue (step 7034). By applying the analysis results and operating the RPT device 4000 with the updated settings, the control of the RPT device 4000 will be more efficiently performed to meet the patient's needs. In some cases, these changes may be made to improve the efficiency of the device's operation (e.g., by reducing power consumption or lowering the temperature of the heating tube that delivers air) without significant sacrifice of patient comfort.

[0127] After a predetermined period of time, one or more previously made feedback requests and / or new feedback requests may be presented to the patient, and a response may be received (step 7036). This response may be used to determine whether the previously applied settings were effective and / or whether further changes to the operation and / or use of the RPT device 4000 are necessary. Further feedback requests may be made periodically or when new feedback requests become available via the remote computing system.

[0128] In some cases, a request for further feedback may appear each time the user powers on the RPT device 4000. When the RPT device 400 is used, the patient may be shown a sleep score and daily insights (e.g., daily recommendations that may be personalized based on feedback from the patient and / or other patients). Providing further feedback may include the user updating one or more of the previously provided feedback (e.g., age, height, weight, and / or sleep feedback).

[0129] In one embodiment of this technology, several feedback requests may be presented on the RPT device 4000, and other feedback requests may be presented on a local external device 4288 or another medical device associated with the same patient 1000. A feedback request presented on one device may be marked as not being requested on other devices because it is currently being displayed.

[0130] In one embodiment of this technology, operations related to displaying feedback requests and receiving feedback request input may be performed during device setup (step 7010).

[0131] Figure 4J shows another example of the operation performed by the RPT device 4000 and the remote computing system. In the example shown in Figure 4H, the feedback request data is pre-stored on the RPT device 4000. For example, the feedback request data may be pre-stored in memory by the manufacturer, distributor, or clinician. In the example shown in Figure 4J, the remote computing system transmits the feedback request data (step 7016). The RPT device 4000 receives the transmitted feedback request data from the remote computing system (step 7014) and uses this data to receive feedback from the patient. In some examples, the system transmitting the feedback request data may be a separate system from the system that performs analysis using the demographic and / or subjective feedback data transmitted from the RPT device 4000.

[0132] The remote computing system may send feedback request data in response to a request from the RPT device 4000. In some examples, the remote computing system may push the feedback request data to the RPT device 4000 at a predetermined time interval or on an ad-hoc basis (directly or through a home medical device).

[0133] Feedback request data may be entered by a physician or clinician. The physician or clinician may be provided with a user interface for entering their own questions as part of the feedback request data. The physician or clinician may be provided with features for asking questions to their patients via the RPT device 4000 or a device associated with the RPT device 4000 (e.g., local external device 4288). For example, the physician or clinician may enter questions using a remote computing system. The physician or clinician may associate one or more of these questions with one or more conditions for distributing the questions to the RPT device 4000. Such conditions may include one or more patient characteristics, device type, peripheral devices connected to the RPT device 4000 (e.g., mask type, tube), and / or device operating parameters.

[0134] Figure 4K is a data flow diagram in a system that provides communication between a medical device (e.g., RPT device 4000), a patient portal 8030, and a patient statistics survey service 8010.

[0135] The Patient Statistics Survey Service 8010 may run on one or more servers (which may include cloud and / or dedicated servers (e.g., server 6030)). The Patient Statistics Survey Service 8010 may coordinate the management and communication of questions and answers regarding demographic and subjective feedback. As shown in Figure 4K, the Patient Statistics Survey Service 8010 may support sending questions to patient accounts associated with medical devices. Patient accounts may be accessed via a web application or mobile application running on local device 4288 or via RPT device 4000. Patient accounts accessed via the web application or mobile application may provide monitoring, reporting, and / or configuration of medical devices, as well as coaching to patients.

[0136] The Patient Statistics Survey Service 8020 may notify the client when a question becomes available. A question may become available if it has been added to a content management system (e.g., through marketing). These questions may be retrieved from the Patient Statistics Survey Service 8020 via a GET call. For example, when a patient's account is accessed via a web or mobile application, the Patient Statistics Survey Service 8020 may be called, and the question retrieval may occur via a proxy through the Patient Portal 8030. These questions may be provided in JavaScript Object Notation (JSON) format, indicating the question content and possible answers. The question presentation may be embedded within the application as HTML content. When a patient's account is accessed via a web or mobile application, the response may be sent back to the Patient Statistics Survey Service 8020 via a proxy through the Patient Portal 8030 (e.g., via a POST instruction).

[0137] A medical device may call home, obtain questions via MCS device 8024 through a proxy, and submit responses to Patient Statistics Survey Service 8020 via MCS device 8024 through a proxy (e.g., via a POST instruction). A GET call may include the serial number of the medical device for Patient Statistics Survey Service 8010 (to track which questions were sent to which devices and / or applications).

[0138] In one embodiment, the patient statistics survey service 8010 may manage questions so that they become available on the patient portal after a predetermined period (e.g., 48 hours). As a result, the occurrence of questions being asked twice can be minimized.

[0139] In another embodiment, the patient statistics survey service 8010 may manage questions so that questions that a patient has already answered are not displayed again. For example, the patient statistics survey service 8010 may track answered questions on one platform (e.g., a medical device) and prevent those questions from being displayed on the patient's account accessed via a web application or mobile application.

[0140] Responses to questions may be received by the patient statistics survey service 8010 from patient accounts accessed via medical devices, web applications, or mobile applications. These responses may be sent to the cloud computing platform 6040 for advanced analysis. The cloud computing platform may contain analytical data lakes along with data from numerous other patients. Deep neural networks may be used for model building and analysis of received responses. In some examples, the patient statistics survey service 8010 may place received responses in a queue for advanced analysis consumption.

[0141] The patient statistics survey service 8010 may support the delivery of questions and / or answers to a remote patient monitoring system. Remote monitoring may be provided via a web application or mobile application running on a remote external device 4286. Remote monitoring may provide a secure cloud-based patient management system for online patient monitoring, enabling clinicians to quickly access patient data, share clinical insights with other health professionals, and reduce patient follow-up costs. Remote monitoring may receive information on the operation of medical devices, compliance information, device settings, changes to device settings, questions presented to patients, and / or answers received from patients. Using data obtained from remote monitoring, clinicians may propose further changes to the patient's coaching program and / or personalized treatment.

[0142] The Patient Statistics Survey Service 8010 may support the reception of initial hardcoded questions from medical devices. During manufacturing, initial questions may be loaded into the medical device. The medical device may present initial questions and receive responses to them during setup or when certain conditions are met (e.g., after the medical device has been used for a predetermined period or after a predetermined period has elapsed since setup). These initial questions may be transmitted from the medical device to the Patient Statistics Survey Service 8010 and delivered to remote monitoring and / or web or mobile applications. In some cases, if initial questions are not answered on the medical device, they may be made available via the web or mobile application. The Patient Statistics Survey Service 8010 may track which of the initial questions have been answered.

[0143] In some examples, the initial questions stored on the medical device may be provided separately to the patient statistics survey service 8010 by the manufacturer. In this example, the patient statistics survey service 8010 may receive the medical device identification information (e.g., serial number) and the initial questions stored on the medical device. The initial questions stored on different medical devices may depend on the type of device and / or the features provided by the device.

[0144] The patient portal 8030 may receive coaching content to provide patients with instructions on how to use the device, how to improve device use, and / or how to improve results from the device. Coaching services may provide coaching content based on the results of an analysis of the patient's demographic and / or subjective feedback.

[0145] 5.6.1 Oxygen Delivery In one embodiment of this technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.

[0146] 5.7 Humidifier In one embodiment of this technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (for example, as shown in Figure 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and temperature of the airflow before it is delivered to the patient's airway.

[0147] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some embodiments, such as those shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0148] According to one configuration, the reservoir 5110 includes a conductive part 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110, a humidifier reservoir dock 5130 (as shown in Figure 5B) configured to receive the reservoir 5110 and / or (as shown in Figures 5A-5B) together with a locking lever 5135 configured to hold a water level indicator 5150, and / or one or more humidifier transducers (Sensor) added to or replacing the transducer 4270 described above. (S) Includes 5210. The humidifier converter 5210 may include one or more of the following: air pressure sensor 5212, air flow converter 5214, temperature sensor 5216, or humidity sensor 5218, as shown in Figure 5C. The humidifier converter 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier converter may be located outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signals to the controller.

[0149] In one configuration of this technology, the humidifier 5000 may include a humidifier controller 5250 as shown in Figure 5C. In one embodiment, the humidifier controller 5250 may be part of a central controller 4230. In another embodiment, the humidifier controller 5250 may be a separate controller capable of communicating with the central controller 4230.

[0150] In one embodiment, the humidifier controller 5250 may receive measurements of characteristics (e.g., temperature, humidity, pressure, and / or flow rate) as input (e.g., measurements of airflow and water in the reservoir 5110 and / or humidifier 5000). The humidifier controller 5250 may also be configured to execute or perform humidifier algorithms and / or deliver one or more output signals.

[0151] As shown in Figure 5C, the humidifier controller 5250 may include one or more controllers (for example, 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 heated element controller 5252 configured to control the temperature of the heated element 5240).

[0152] An example of a humidifier component is described in PCT application PCT / AU2014 / 050426 (WO2015089582). This document is incorporated herein by reference.

[0153] 5.8 Respiratory pressure therapy modes Depending on the values ​​of parameters A and P0 in the therapeutic pressure equation (1) used by the therapeutic parameter determination algorithm 4329 in one embodiment of this technology, various respiratory pressure therapy modes can be performed by the RPT device 4000.

[0154] 5.8.1 CPAP treatment In several embodiments of this form of the technology, since the amplitude A is always zero, the therapeutic pressure Pt is similarly equal to the base pressure P0 throughout the entire respiratory cycle. Such embodiments are mainly grouped under the heading of CPAP therapy. In such embodiments, the therapeutic engine module 4320 for determining the phase Φ or waveform template Π(Φ) is not required. In step 4560, if the reduced base pressure P0 is not below the minimum therapeutic pressure Pmin, the central controller 4230 reduces the base pressure P0 by a decrement. Method 4500 then returns to step 4520. In one embodiment, since the decrement is proportional to the value of P0-Pmin, the reduction of P0 to the minimum therapeutic pressure Pmin is exponential, assuming no events are detected. In one run, the constant of the proportional relationship is set such that the time constant τ of the exponential reduction of P0 is 60 minutes and the minimum therapeutic pressure Pmin is 4 cmH2O. In other implementations, the time constant τ can be as short as 1 minute and as long as 300 minutes, or as short as 5 minutes and as long as 180 minutes. In other embodiments, the minimum therapeutic pressure Pmin can be as low as 0 cmH2O and as high as 8 cmH2O, or as low as 2 cmH2O and as high as 6 cmH2O. Alternatively, the decrement of P0 may be predetermined so that the decrease in P0 to the minimum therapeutic pressure Pmin is linear in the absence of detected events.

[0155] 5.8.2 Bilevel Therapy In other embodiments of this form of the technology, the value of amplitude A in equation (1) may be positive. Such an implementation is known as bilevel therapy. This is because, when the therapeutic pressure Pt is determined using equation (1) with a positive amplitude A, the therapeutic parameter determination algorithm 4329 oscillates the therapeutic pressure Pt between two values ​​or levels in synchronization with the spontaneous respiratory effort of patient 1000. That is, based on the typical waveform template Π(Φ,t) described above, the therapeutic parameter determination algorithm 4329 increases the therapeutic pressure Pt to P0+A (known as IPAP) at the start of inspiration or during inspiration, and decreases the therapeutic pressure Pt to the base pressure P0 (known as EPAP) at the start of expiration or during expiration.

[0156] In some forms of bilevel therapy, IPAP is the same therapeutic pressure as in CPAP therapy mode, and EPAP is the IPAP minus amplitude A, and has a “small” value (a few cmH2O) also called expiratory pressure release (EPR). This form is also called CPAP therapy with EPR and is generally considered to be more comfortable than direct CPAP therapy. In CPAP therapy with EPR, either or both IPAP and EPAP can be constant values ​​and are hardcoded or manually entered into the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate IPAP and / or EPAP in the case of CPAP with EPR. In this alternative example, the therapy parameter determination algorithm 4329 iteratively calculates EPAP and / or IPAP as a function of sleep disorder breathing indices or measurements returned from each algorithm in the therapy engine module 4320. This is done similarly to the calculation of base pressure P0 in APAP therapy described above.

[0157] In other forms of bilevel therapy, the amplitude A is large enough for the RPT device 4000 to perform some or all of the patient's breathing motion. In such forms known as pressure-assisted ventilation therapy, the amplitude A is called pressure assist or swing. In pressure-assisted ventilation therapy, IPAP is base pressure P0 + pressure assist A, and EPAP is base pressure P0.

[0158] In some forms of pressure-assisted ventilation known as constant-pressure assisted ventilation therapy, the pressure assist A is fixed to a predetermined value (e.g., 10 cmH2O). The predetermined pressure assist value is a setting of the RPT device 4000, which can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220.

[0159] In other forms of pressure-assisted ventilation therapy, widely known as servo ventilation, the treatment parameter determination algorithm 4329 takes a constant currently measured or estimated parameter of the respiratory cycle (e.g., current measurement of ventilation Vent) and a target value for the respiratory parameter (e.g., target value of ventilation Vtgt) as inputs, and continuously adjusts the parameter in equation (1) to bring the current measurement of the respiratory parameter closer to the target value. In forms of servo-ventilation known as adaptive servo ventilation (ASV) used in CSR therapy, the respiratory parameter is ventilation, and the target ventilation value Vtgt is calculated from a typical recent ventilation Vtyp as described above by the target ventilation determination algorithm 4328.

[0160] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control method that iteratively calculates pressure assist A to bring the current measurements of respiratory parameters to target values. One such control method is proportional-integral (PI) control. In one embodiment of PI control suitable for an ASV mode set so that the target ventilation Vtgt is slightly lower than a typical recent ventilation Vtyp, pressure assist A is iteratively calculated as follows:

number

[0161] Other servo ventilation control methods that can be applied by the treatment parameter determination algorithm 4329 include proportional (P), proportional-difference (PD), and proportional-integral-difference (PID).

[0162] The value of pressure auxiliary A calculated via the equation () can be clipped to a range defined as [Amin, Amax]. In this embodiment, pressure auxiliary A is set by default to minimum pressure auxiliary Amin until the current ventilation measurement Vent falls below the target ventilation Vtgt. A begins to increase when the current ventilation measurement Vent falls below the target ventilation Vtgt, and only decreases to Amin when Vent exceeds Vtgt again.

[0163] The pressure assist limits Amin and Amax are settings of the RPT device 4000, which are set, for example, hardcoded when configuring the RPT device 4000 or by manual input through the input device 4220.

[0164] In pressure-assisted ventilation therapy mode, EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP therapy, EPAP can be a constant value and is defined or determined during titration. Such a constant EPAP can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220. This alternative is also called fixed EPAP pressure-assisted ventilation therapy. Titration of EPAP for a given patient may be performed by a clinician during a titration session using PSG for the purpose of preventing obstructive apnea, thereby maintaining airway security for pressure-assisted ventilation therapy in a manner similar to the titration of base pressure P0 in constant CPAP therapy.

[0165] Alternatively, the treatment parameter determination algorithm 4329 may iteratively calculate the base pressure P0 during pressure-assisted ventilation therapy. In such an embodiment, the treatment parameter determination algorithm 4329 iteratively calculates EPAP as a function of sleep-disordered breathing indicators or measurements (e.g., one or more of flow limitation, apnea, respiratory depression, patency, and snoring) returned from each algorithm in the treatment engine module 4320. Because the continuous calculation of EPAP is analogous to the manual adjustment of EPAP by a clinician during EPAP titration, this process is also called automated titration of EPAP, and the treatment mode is known as automated titration EPAP pressure-assisted ventilation therapy or automated EPAP pressure-assisted ventilation therapy.

[0166] 5.9 Glossary For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. Other definitions may also apply in other forms of this technology.

[0167] 5.9.1 General Air: In certain forms of this technology, air may mean the atmosphere, and in other forms of this technology, air may mean a combination of other breathable gases (e.g., an oxygen-rich atmosphere).

[0168] Environment: In certain forms of this technology, the term “environment” should be understood to mean (i) the area outside the treatment system or patient, and (ii) the area directly surrounding the treatment system or patient.

[0169] For example, the ambient humidity for a humidifier could be the humidity of the air directly surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). This ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0170] In another embodiment, the environmental pressure may be the pressure directly around or outside the body.

[0171] In certain forms, environmental (e.g., acoustic) noise can be considered the background noise level in the patient's room, excluding noise originating from, for example, RPT devices or masks or patient interfaces. Environmental noise may originate from sources outside the room.

[0172] Automatic positive airway pressure (APAP) therapy: CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0173] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (e.g., increased in response to the detection of signs of partial upper airway obstruction and decreased in the absence of such indications).

[0174] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when flow rate is mentioned, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be denoted by the sign Q. Flow rate is sometimes simply called "flow" or "airflow."

[0175] In the patient's respiratory embodiment, the flow rate can be negative relative to the expiratory portion of the patient's respiratory cycle, as it can be nominally positive relative to the inspiratory portion of the patient's respiratory cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Vent flow rate Qv is the flow rate of air exiting the vents to allow the exhaled gas to escape. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0176] Humidifier: The term "humidifier" is interpreted as a humidifying device that is constructed, positioned, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor into the airflow to improve a patient's medical respiratory condition.

[0177] Leakage: The term "leakage" is taken to mean an unintended flow of air. In one embodiment, leakage may occur due to an incomplete seal between the mask and the patient's face. In another embodiment, leakage may occur at the circumferential elbow to the surroundings.

[0178] Conducted Noise (Acoustics): In this document, conducted noise refers to noise transmitted to a patient via pneumatic pathways (e.g., air circuits and patient interfaces and the air within them). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0179] Noise Radiation (Acoustic): In this document, radiated noise refers to noise transmitted to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO 3744.

[0180] Noise from ventilation (acoustics): In this document, ventilation noise refers to noise generated by airflow through any ventilation (e.g., ventilation holes in a patient interface).

[0181] Patient: A person who has or does not have a respiratory illness.

[0182] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, gf / cm²). 2 , and hectopascals). 1 cmH2O is 1 g-f / cm 2 This is equal to approximately 0.98 hectopascals. In this specification, unless otherwise specified, pressure is given in units of cmH2O.

[0183] The pressure within the patient interface is denoted by the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at the current moment, is denoted by the symbol Pt.

[0184] Respiratory pressure therapy (RPT): Addition of air supply to the airway inlet at therapeutic pressure, which is typically positive pressure relative to the environment.

[0185] Ventilator: A mechanical device that provides pressure assistance to help a patient perform some or all of the breathing motion.

[0186] 5.9.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when airflow falls below a certain threshold for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's exertion. Central apnea is said to refer to a condition in which apnea is detected due to decreased or absent respiratory effort, even though the airway is open. Mixed apnea is said to refer to a condition in which decreased or absent respiratory effort occurs simultaneously with airway obstruction.

[0187] Respiratory rate: This is the patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0188] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0189] Exercise (breathing): Breathing effort is said to refer to the movements performed by a person's spontaneous breathing.

[0190] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0191] Flow restriction: Flow restriction is interpreted as a situation in a patient's respiration where increased exertion by the patient does not result in a corresponding increase in flow rate. If flow restriction occurs during the inspiratory portion of the respiratory cycle, it may be referred to as inspiratory flow restriction. If flow restriction occurs during the expiratory portion of the respiratory cycle, it may be referred to as expiratory flow restriction.

[0192] Types of flow-restricted intake waveforms: (i) Flattening: A period of rising followed by a relatively flat section, after which a descent occurs. (ii) M-shaped: It has two local peaks, one at the rise and one at the fall, with a relatively flat area between these two peaks. (iii) Chair-shaped: Has a single localized peak, which rises from the beginning and is followed by a relatively flat area. (iv) Inverted chair shape: A relatively flat area is followed by a single localized peak, and this peak occurs in the sloping portion.

[0193] Respiratory depression: According to some definitions, respiratory depression refers to a decrease in flow, rather than an interruption of flow. In one morphology, respiratory depression is said to have occurred if a decrease in flow below a threshold velocity persists for a period of time. If respiratory depression is detected due to a decrease in respiratory effort, it is said to have occurred. In one morphology of an adult, respiratory depression may be considered if any of the following occurs: (i) A 30% decrease in patient respiration lasting at least 10 seconds + associated 4% desaturation, or (ii) The patient's respiration decreases by less than 50% for at least 10 seconds, and associated desaturation is at least 3% or awakening occurs.

[0194] Hyperventilation: A condition in which blood flow increases to a level higher than normal.

[0195] The inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0196] Airway patency: The degree to which the airway is open or the extent to which the airway is open. Airway patency is defined as opening. Airway patency can be quantified, for example, using a value of (1) indicating patency and a value of (0) indicating closure (obstruction).

[0197] Positive end-respiratory pressure (PEEP): This is the pressure in the lungs that exceeds the atmospheric pressure, and is present at the end of exhalation.

[0198] Peak flow rate (Qpeak): The maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0199] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): These terms may be understood to refer to the estimation of respiratory airflow by an RPT device and are used in contrast to "true respiratory flow" or "true respiratory airflow," which is the patient's actual respiratory flow, usually expressed in liters / minute.

[0200] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort. In principle, inspiratory volume Vt i (Amount of air inhaled) is equal to the amount of air exhaled. e (The amount of air exhaled) is equal to the single tidal volume V t It can be defined as being equal to any of the following quantities. In practice, the tidal volume V t This is some combination (for example, intake volume V i and exhalation volume V e It is estimated as the average of [the specified values].

[0201] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0202] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0203] (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.

[0204] Typical recent ventilation: Ventilation values ​​where recent ventilation values ​​tend to cluster together over a given time scale (i.e., the degree of clustering of recent ventilation values).

[0205] Upper airway obstruction (UAO): Includes both partial and total upper airway obstruction. It may be associated with flow-limiting conditions in which flow rate may slightly increase or decrease with increasing pressure differences over the upper airway (Stirling register behavior).

[0206] Ventilation: A measurement of the rate of gas exchange performed by a patient's respiratory system. Ventilation measurements may include either or both inspiratory and expiratory airflow per unit time. When expressed as volume per minute, this volume is often called "minute ventilation." Minute ventilation may also simply be given as volume and understood as volume per minute. 5.10 Other Notes

[0207] Some of the disclosures in this patent document include content that is protected by copyright. The copyright holder retains all copyrights to any other purpose, except that any reproduction of this patent document or this patent disclosure by fax by any person is permitted if it is included in the patent files or records of the Japan Patent Office.

[0208] Unless otherwise clearly indicated by the context or provided for a range of values, it is understood that 1 / 10 of the lower limit, the interval between the upper and lower limits of the range, and each intervention value for any other stated values ​​or intervention values ​​within the stated range are included in this technique. Even if the upper and lower limits of these intervention ranges, independently included within the intervention range, specifically exceed the limits within the stated range, they are also included in this technique. If the stated range includes one or both of these limits, the range exceeding either or both of these stated limits is also included in this technique.

[0209] Furthermore, where values ​​(one or more) are embodied in this specification as part of the Art, unless otherwise specified, it is understood that such values ​​may be approximated and used to any appropriate number of significant figures to the extent permitted or required by the practical technical implementation.

[0210] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as those commonly understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this art, but only a limited number of exemplary methods and materials are described herein.

[0211] While certain materials are described as suitably used in constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are understood to be manufacturable and therefore can be manufactured collectively or individually.

[0212] Note that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0213] All published documents cited herein are used for disclosure and description of methods and / or materials that are the subject of those documents, and are incorporated for reference only. The published documents cited herein are provided solely for the purposes of their disclosure prior to the filing date of this application. Nothing in this specification should be construed as acknowledging or acknowledging that the present technology is not prior to such published documents for the purpose of prior patents. Furthermore, the dates of the published documents cited herein may differ from the actual dates of the published documents and may require individual verification.

[0214] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the elements, components, or steps described may exist, be used, or be combined with other elements, components, or steps not explicitly stated.

[0215] The headings used in the detailed descriptions are for the convenience of the reader and should not be used to limit the content found in this disclosure or the claims as a whole. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0216] While the techniques described herein have been referred to with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may indicate specific details that are not necessary for carrying out the techniques. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any arbitrary order and are used to distinguish separate elements. Furthermore, while the process steps in the methods may be described or illustrated in order, such order is not necessary. Those skilled in the art will recognize that such order is changeable and / or that such actions can be performed simultaneously or even synchronously.

[0217] Therefore, it should be understood that numerous modifications are possible in the exemplary embodiments, and other configurations may be devised, without deviating from the intent and scope of this technology. [Explanation of symbols]

[0218] 5.11 Explanation of Symbols 1000 patients 1002 Other patients 1004 Other patients 1100 Bedmate 3000 Patient Interfaces 4000 RPT devices 4010 External Housing 4012 Top 4014 parts 4015 Panel (Multiple Panels Possible) 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet air filter 4114 Outlet air filter 4120 Muffler 4122 Entrance muffler 4124 Exhaust muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4171 Air Circuit 4180 Supplemental oxygen 4200 Electrical components 4202 Single Printed Circuit Board Assembly 4210 Power supply 4220 Input Devices 4230 Central Controller 4232 Clock 4240 Therapeutic Device Controller 4250 protection circuit 4260 memory 4270 Converter 4272 Pressure Sensor 4274 Flow Sensor 4276 Speed ​​Sensor 4280 Data communication interface 4282 Remote External Communication Network 4284 Local external communication network 4286 Remote External Devices 4288 Local external device 4290 Output Device 4292 Display Driver 4294 displays 4300 Algorithms 4310 Preprocessing Module 4312 Pressure Compensation Algorithm 4314 Estimation of airflow rate 4316 Leakage Flow Rate Estimation 4316 Leakage Flow Rate Estimation 4318 Respiratory flow estimation 4320 Therapeutic Engine Module 4321 Phase Determination Algorithm 4322 Waveform Determination Algorithm 4323 Ventilation Decision Algorithm 4324 Intake Airflow Limit Determination Algorithm 4325 Apnea / Respiratory Decision Algorithm 4326 Snoring Determination Algorithm 4326 Snoring Determination Algorithm 4326 Snoring Determination Algorithm 4327 Airway Patency Determination Algorithm 4328 Target ventilation determination algorithm 4329 Treatment parameter determination algorithm 4330 Treatment control module 4340 Algorithms 4500 methods 4520 steps 4560 steps 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Reservoir 5120 Conductive parts 5130 Humidifier Reservoir Dock 5135 Locking Lever 5150 Water Level Indicator 5210 Humidifier Converter 5212 Pressure transducer 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 5286 Remote External Device 6020 Communication Link 6030 Server 6040 Cloud Computing Platform 6062 Medical Devices 6064 Medical Devices 7010 Setup Steps 7012 Steps 7014 Steps 7016 Steps 7018 Steps 7020 Steps 7022 steps 7024 steps 7026 steps 7028 steps 7030 steps 7032 steps 7034 steps 7036 steps 7050 display screen 7052 Display screen 7054 Display screen 7056 Display screen 7058 Display screen 7060 display screen 7062 Display screen 7064 Display screen 8010 Patient Statistics Survey Service 8020 Patient Statistics Survey Service 8024 MCS device 8030 Patient Portal

Claims

1. A method for operating a respiratory therapy device that generates airflow for the treatment of respiratory disorders, A step of setting up a respiratory therapy device using a controller before the patient's initial use of the device, wherein the setup of the device comprises the steps of assigning the device to the patient and initializing the settings of the device, During the operation of the device in the initialized settings, the steps include receiving sensor data via a transducer based on measuring the characteristics of the airflow, The controller includes the step of calculating a result based on the sensor data, which includes at least one of the following: respiratory events, patient's cardiac respiratory characteristics, and patient's physical condition. The steps include controlling the operation of the device using the controller based on the results and the initialized settings of the device, After the predetermined conditions for the patient to use the device are met based on the initialized settings of the device: A step of displaying user input controls for one or more questions relating to subjective feedback, wherein the user input controls include a variable scale controllable between opposing endpoints, where the first endpoint of the opposing endpoints represents a first subjective response, and the second endpoint of the opposing endpoints represents a second subjective response. The steps include receiving one or more user inputs for selecting values ​​along a variable scale in order to provide answers to the one or more questions relating to the subjective feedback in response to the display of one or more questions, The steps include sending the answers to one or more of the above questions to a remote processing system, The steps include receiving from the remote processing system settings for the operation of the respiratory therapy device and an individualized coaching program for the patient, based on the response transmitted to the remote processing system, The steps include adjusting the settings of the respiratory therapy device based on the received settings, A method that includes this.

2. After the predetermined conditions relating to the patient's use of the device based on the initialized settings of the device are met, A step of displaying one or more questions relating to demographic feedback and selectable responses to one or more questions relating to the demographic feedback, wherein the demographic feedback includes feedback relating to the patient's sex, age, height, or weight. In response to the display of one or more questions, the controller receives one or more user inputs for selectable responses indicating answers to one or more questions related to the demographic feedback. The steps include transmitting the answers to one or more questions related to the demographic feedback to a remote processing system, The method according to claim 1, further comprising:

3. The method according to claim 1 or 2, wherein the settings for the operation of the respiratory therapy device are determined based on the response transmitted to the remote processing system upon receipt of the input indicating the response, and the control settings of the respiratory therapy device, and the patient is provided with individually tailored treatment.

4. The above question is the method according to any one of claims 1 to 3, which is displayed on the display of the respiratory therapy device.

5. The method according to any one of claims 1 to 3, wherein the aforementioned question is displayed on a mobile device configured to run an application for controlling the respiratory therapy device.

6. The method according to any one of claims 1 to 5, wherein the predetermined condition includes that a predetermined time has elapsed since the setup of the device was performed.

7. The method according to any one of claims 1 to 5, wherein the predetermined conditions include a predetermined period of time after the setup of the apparatus during which the respiratory therapy device is operated by the patient.

8. The method according to claim 1, wherein the personalized coaching program includes instructions on how to properly use the respiratory pressure therapy, a description of the benefits of using the functions provided by the respiratory pressure therapy system, and / or suggestions of other medical devices and / or accessories that may be beneficial to the patient.

9. A respiratory pressure therapy system that provides continuous positive pressure (CPAP) to a patient using a device, A flow generator configured to produce a supply of breathable gas for delivery to a patient, wherein the breathable gas is output from the flow generator at a pressure level exceeding the ambient pressure, At least one sensor configured to measure the physical properties associated with the breathable gas while the breathable gas is being supplied to the patient, A computing device including memory and at least one hardware processor, Includes, The computing device is Setting up the device before the patient's first use of the respiratory pressure therapy system, the setup of the device includes assigning the device to the patient and initializing the device settings. During the operation of the device in the initialized settings, sensor data based on the measured physical characteristics of the breathable gas supply is received from at least one sensor, The flow generator is controlled based on the received sensor data and the initialized settings of the device to adjust the characteristics of the supply of the breathable gas delivered to the patient. It is configured to do the following: After a predetermined period has elapsed following the fulfillment of predetermined conditions related to the patient's use of the device based on the initialized settings of the device, Displaying a user input control on a display device that displays one or more questions related to subjective feedback, wherein the user input control includes a variable scale controllable between opposing endpoints, the first endpoint of the opposing endpoints representing a first subjective response, and the second endpoint of the opposing endpoints representing a second subjective response. In response to the display of one or more of the above questions, in order to provide answers to the one or more of the above questions related to the subjective feedback, the system receives one or more user inputs that control the variable scale, Sending the answers to one or more of the above questions to a remote processing system, The remote processing system receives the settings for the operation of the respiratory pressure therapy system and the patient's personalized coaching program, which are determined based on the transmitted response. Based on the received settings, adjust the settings of the respiratory pressure therapy system. A respiratory pressure therapy system, further configured to perform the following actions.

10. The respiratory pressure therapy system according to claim 9, wherein assigning the device to the patient includes receiving answers to one or more questions relating to demographic feedback, wherein the demographic feedback includes feedback relating to the patient's sex, age, height, or weight.

11. The respiratory pressure therapy system according to claim 9 or 10, wherein the remote processing system is an on-demand cloud computing platform configured to perform machine learning using data received from multiple patients.

12. The respiratory pressure therapy system according to any one of claims 9 to 11, further comprising the remote processing system, wherein the remote processing system is configured to determine a treatment for the patient that is tailored to the patient based on the response transmitted to the remote processing system.

13. The respiratory pressure therapy system according to claim 9, wherein the personalized coaching program includes instructions on how to properly use the respiratory pressure therapy system, a description of the benefits of using the functions provided by the respiratory pressure therapy system, and / or suggestions of other medical devices and / or accessories that may be beneficial to the patient.

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