Two-way communications in medical device

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 March 16, 2019, which is incorporated herein by reference in its entirety.

[0002] 2. Technology Background 2.1 Technology field The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory related diseases. The present technology also relates to medical devices or apparatus and uses thereof. More particularly, the present technology relates to methods and systems for setting up medical devices and providing personalized coaching and / or customized therapy for patients using medical devices. [Background technology]

[0003] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and oral cavity form the entrance to a patient's airways.

[0004] These airways contain a series of branching tubes that become narrower, shorter and more numerous the deeper they go into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and finally into alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of closure or obstruction of the upper airway during sleep. It is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes affected patients to pause in breathing, typically for 30-120 seconds, sometimes as many as 200-300 times per night. This results in excessive daytime sleepiness, which can lead to cardiovascular disease and brain damage. The condition is common, especially in middle-aged, overweight men, but patients are asymptomatic. See U.S. Pat. No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disease of the patient's respiratory regulator, followed by alternating periods of waxing and waning of ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. Because of the repeated hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep arousals that 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 that refers to the inability of the lungs to take in enough oxygen or breathe out enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

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

[0011] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

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

[0013] Neuromuscular diseases (NMD) is a broad term that encompasses numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, resulting in inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified as rapidly and slowly progressive: (i) rapidly progressive disorders, characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle damage that worsens over years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include: increasing generalized weakness, difficulty swallowing, dyspnea on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive defects and share the potential for long-term hypercapnic respiratory insufficiency. Scoliosis and / or kyphoscoliosis can lead to severe respiratory insufficiency. Symptoms of respiratory insufficiency include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor quality of sleep, and loss of appetite.

[0015] A range of treatments are available to treat or ameliorate such conditions, and otherwise healthy individuals may also benefit from preventative treatments for respiratory disease, but these suffer from a number of deficiencies.

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

[0017] Continuous positive airway pressure (CPAP) therapy has been used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, which may prevent the upper airway from closing. Because the treatment of OSA with CPAP therapy may be voluntary, patients may choose not to comply with the treatment if they perceive one or more of the following from the device used to deliver the treatment: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

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

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

[0020] 2.2.3 Treatment system These therapies may be provided by a therapeutic system or device. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

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

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

[0023] There are several challenges in designing a patient interface: The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces; i.e., the chin or mandible may move relative to other bones of the skull. The entire head may move throughout the respiratory treatment period.

[0024] Due to these challenges, some masks can be one or more of the following: intrusive, aesthetically undesirable, costly, fit poorly, are difficult to use, and are uncomfortable, especially when worn for long periods of time or if the patient is unfamiliar with the system.

[0025] CPAP therapy can be highly effective in treating certain respiratory conditions if patients comply with the therapy. Patients may not comply if the mask is uncomfortable, the wrong size, difficult to use, unsuitable for certain patient characteristics (e.g., nasal masks for mouth breathers), or difficult to clean (e.g., difficult to assemble or disassemble).

[0026] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices may be used individually or as part of a system to deliver one or more of the therapies described above, for example by actuating the device to generate an air delivery flow to an interface to the airway. This air flow may be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

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

[0028] RPT devices typically include a pressure generator (e.g., a motorized blower or compressed gas reservoir) and are configured to deliver an airflow to the patient's airway. In some cases, the airflow may be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface as described above.

[0029] A device designer may be presented with a myriad of choices. Often, design criteria conflict, making certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular embodiment may be significantly affected by minor changes in one or more parameters.

[0030] 2.2.3.3 Humidifier Delivery of airflow without humidification can lead to drying of the airway. When a humidifier is used with the RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0031] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory treatment is "compliant" (e.g., whether the patient complies with one or more "compliance rules" with their RPT device). One example of a compliance rule for CPAP treatment may require a patient to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate a usage rate over a period of time, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0032] There may be other aspects of a patient's care that would benefit from communication of treatment data to third parties or external systems.

[0033] Existing processes for communicating and managing such data can be one or more of: costly, time consuming, and error prone. Summary of the Invention [Means for solving the problem]

[0034] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0035] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0036] Another aspect of the present technology relates to methods for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0037] One aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory treatment.

[0038] One form of the present technology includes a respiratory pressure treatment system configured to present demographic and / or subjective questions to a patient, receive responses to those questions, and analyze those questions to determine settings for the respiratory pressure treatment system.

[0039] Another aspect of one form of the present technology is to determine (e.g., via advanced analytics) an individualized coaching program and / or tailored treatment for the patient based on the patient's answers to demographic and / or subjective questions and / or data from multiple other users.

[0040] One form of the present 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 the present technology is to pose demographic and / or subjective questions and receive answers via a web or mobile application.

[0042] Another aspect of one form of the present technology is to receive answers to demographic and / or subjective questions via a web or mobile application and use the answers to determine settings for the respiratory pressure treatment system.

[0043] Another aspect of one form of the present technology is a processing system and a computing system, the processing system including a memory storing a plurality of demographic questions and / or a plurality of objective questions, the computing system configured to: send the demographic and / or objective questions to a medical device and / or a mobile device configured to execute an application for communication with the medical device, receive answers to the questions from the medical device and / or the mobile device, and determine, based on the received answers, a personalized coaching program for the patient and / or a customized treatment with the medical device, e.g., via advanced analytics.

[0044] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or insight, or individuals with limited experience in using medical devices of this type.

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

[0046] In examples, (a) the remote processing system may be an on-demand cloud computing platform configured to perform machine learning using data received from a plurality of patients, (b) the questions may be pre-stored in memory, (c) the computing device may be further configured to perform a set-up operation, and the one or more questions may be displayed after set-up and after a predetermined condition is met, (d) the predetermined condition may include a predetermined period of time that has elapsed after set-up, (e) the questions may include at least one question related to demographic information about the patient and at least one question related to subjective feedback from the patient regarding use of the respiratory pressure therapy system, and (f) the system may further include a remote processing system, and the remote processing system may be configured to perform a set-up operation, and the one or more questions may be pre-stored in memory, (c) the computing device may be further configured to perform a set-up operation, and the one or more questions may be displayed after set-up and after a predetermined condition is met, (d) the predetermined condition may include a predetermined period of time that has elapsed after set-up, (e) the questions may include at least one question related to demographic information about the patient and at least one question related to subjective feedback from the patient regarding use of the respiratory pressure therapy system, and (f) the system may further include a remote processing system, (g) the system may further include a remote processing system, which may be configured to determine a personalized coaching program for the patient based on the answers sent to the remote processing system; (h) the one or more questions may be received from the remote processing system; (i) the system may further include a patient interface configured to engage at least one airway of the patient and a supply of breathable gas to the patient; and / or (j) setting up the respiratory pressure therapy system and / or receiving the personalized coaching program is performed by an application, a website, email, and / or a mobile device associated with the patient.

[0047] Another aspect of the present technology relates to an apparatus for treating a patient's respiratory disorder. The apparatus includes: a display device; a pressure generator configured to generate an airflow for treating the respiratory disorder; a transducer configured to generate a flow signal indicative of a characteristic of the airflow; and a controller connected to the display, the pressure generator, and the transducer. The controller may be configured to: receive a flow signal from the transducer; control the pressure generator to adjust a characteristic 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 indicative of the demographic and / or subjective feedback in response to the request; transmit demographic and / or subjective feedback data determined based on the received one or more inputs to a remote processing system; receive from the remote processing system an analysis result determined based on the transmitted demographic and / or subjective feedback data; and adjust a control setting of the apparatus based on the received analysis result.

[0048] In examples, (a) the controller, display and pressure generator may be housed together, (b) the adjusted control settings may include a therapeutic pressure provided in a patient mask connected to the pressure generator, (c) the analysis results may include an individualized coaching program for the patient, (d) the analysis results may include a customized therapy for the patient, (e) the controller may be configured to transmit the device operation data along with demographic and / or subjective feedback data, and the analysis results may be determined based on the demographic and / or subjective feedback data and the device operation data, (f) the request for demographic and / or subjective feedback may be displayed after a predetermined condition is met, (g) the predetermined condition may be a predetermined period of time after setup of the device, and / or (h) the predetermined condition may be a predetermined period of time the device has been operated by the patient.

[0049] Another aspect of the present technology relates to a method of operating a respiratory treatment device that generates an airflow for the treatment of disordered breathing, the method including measuring a characteristic of the airflow with a transducer; calculating in the controller a result including at least one of a respiratory event, a cardiorespiratory characteristic of the patient, and a physical condition of the patient based on the measured characteristic; controlling in the controller an adjustment of the characteristic of the airflow based on the result; displaying one or more questions related to demographic and / or subjective feedback; receiving in the controller one or more inputs in response to displaying the one or more questions indicative of answers to the one or more questions; transmitting the answers to a remote processing system; and receiving from the remote processing system settings for operation of the respiratory treatment device and / or a personalized coaching program for the patient based on the answers transmitted to the remote processing system.

[0050] In examples, (a) the method may include adjusting control settings of the respiratory treatment device based on the received settings, (b) settings for operation of the respiratory treatment device may provide the patient with a customized therapy determined based on the answer transmitted to the remote processing system upon receipt of the input indicative of the answer and the control settings of the respiratory treatment device, (c) the question may be displayed on a display of the respiratory treatment device, (d) the question may be displayed on a mobile device configured to execute an application for control of the respiratory treatment device, (e) the question may be displayed after a predetermined condition is met, (f) the predetermined condition may be a predetermined period of time after the respiratory treatment device is set up, and / or (g) the predetermined condition may be a predetermined period of time the respiratory treatment device has been operated by the patient.

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

[0052] In examples, (a) the computing system may be further configured to receive from the medical device an answer to a question pre-stored on the medical device and answered using the medical device, (b) the medical device may be a respiratory treatment device, (c) the question may be sent to the mobile device and / or the medical device after a predetermined condition is met, (d) the predetermined condition may be a predetermined period of time after the medical device is set up, and / or (e) the predetermined condition may be a predetermined period of time after the medical device is operated by the patient. The described methods, systems, devices and apparatus may be embodied to enable improved functionality in a processor (e.g., a processor of a special purpose computer, a respiratory monitor and / or a respiratory treatment device). Furthermore, the described methods, systems, devices and apparatus enable improvements in the field of automated management, monitoring and / or treatment of respiratory conditions (e.g., sleep disorder breathing).

[0053] Of course, some of the above aspects may form sub-aspects of the present technology, and various one of the sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0054] Other features of the present 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 The present technology is illustrated by way of one non-limiting example in the accompanying drawings, in which like reference symbols include like elements: [Brief description of the drawings]

[0056] 4.1 Treatment system [Figure 1]The system is shown to include a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleep position. [Diagram 2] A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Diagram 3] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 RPT Device [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] FIG. 1 is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology. The upstream and downstream directions are shown relative 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 located in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] FIG. 1 is a schematic diagram of electrical components of an RPT device in accordance with one form of the present technology. [Figure 4D] FIG. 1 is a schematic diagram of electrical components of an RPT device in accordance with one form of the present technology. [Figure 4E]FIG. 1 is a schematic diagram of an algorithm executed in an RPT device in accordance with one form of the present technology. [Figure 4F] 4E is a flow chart illustrating a method performed by the treatment engine module of FIG. 4E in accordance with one aspect of the present technology. [Figure 4G] FIG. 1 is a diagram of a communication system between an RPT device and a remote computing system in accordance with one form of the present technology. [Figure 4H] 1 illustrates exemplary operations performed by an RPT device and a remote computing system in accordance with one aspect of the present technology. [Figure 4I] 13A-13C show example display screens including demographic and / or subjective feedback requests that may be displayed to a patient in accordance with one form of the present technology. [Figure 4J] 11 is another example of operations performed by an RPT device and a remote computing system in accordance with one aspect of the present technology. [Figure 4K] FIG. 4.3 Humidifier [Figure 5A] FIG. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] Shown is an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 5C] FIG. 1 is a schematic diagram of a humidifier in accordance with one form of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0057] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It should also be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0058] The following description is provided in conjunction with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.

[0059] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including the step of applying positive pressure to an entrance to the airways of a patient 1000.

[0060] In a particular embodiment of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

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

[0062] 5.2 Treatment system In one form, the present 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 the present technology includes one or more of the following functionalities: 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 forms, the functionalities may be provided by one or more physical components. In some forms, a single physical component may provide one or more functionalities. In use, the seal-forming structure is positioned to surround an entrance to the patient's airway to facilitate the supply of air at positive pressure to the airway.

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

[0065] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 4 cmH2O relative to ambient, at least 6 cmH2O relative to ambient, at least 10 cmH2O relative to ambient, at least 20 cmH2O relative to ambient, at least 30 cmH2O relative to ambient, or any pressure between at least 4 cmH2O and 30 cmH2O relative to ambient.

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

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

[0068] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions, an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0069] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 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 pneumatic path items may be disposed within a removable unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

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

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

[0073] According to one example, the user interface panel includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a human to interact with the device. The buttons, switches, or dials may be physical or software devices accessible via a touch screen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may communicate wirelessly with a receiver electrically connected to the central controller 4230 in another form.

[0074] In one form, the input device 4220 may be constructed and arranged to allow a human to select values ​​and / or menu options.

[0075] 5.4.1.1 Data communication systems In one form of the present technology, a data communications interface 4280 is provided and connected to the central controller 4230. The data communications interface 4280 may be connectable to a remote external communications network 4282 and / or a local external communications network 4284. The remote external communications network 4282 may be connectable to a remote external device 4286. The local external communications network 4284 may be connectable to a local external device 4288.

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

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

[0078] In one form, the local external communications network 4284 uses one or more communications standards (eg, Bluetooth or Consumer Infrared Protocol).

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

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

[0081] 5.4.1.2 Optional displays and output devices, including alarms Output devices 4290 according to the present technology may take the form of one or more of visual, audio and tactile 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 Drivers The display driver 4292 receives as input characters, symbols or images to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols or images.

[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 eight-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the number "0") into eight logic signals indicating which of the eight segments should be activated to display the particular character or symbol.

[0084] 5.4.2 RPT Device Algorithm As noted above, in some forms of the technology, the central controller 4230 may be configured to embody one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer readable storage medium (e.g., memory 4260). The algorithms 4300 are generally grouped into groups called modules. The modules may include a pre-processing module 4310 that provides pressure compensation 4312, ventilation flow estimate 4314, leakage flow estimate 4316, and respiratory flow estimate 4318. The processing of the pre-processing module 4310 may be used as input into the therapy engine module 4320. The therapy 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 / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapy parameter determination 4329. The therapy control module 4330 receives as input therapy parameters from a therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver airflow from the pressure generator 4140 in accordance with these therapy parameters. In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detection of a fault condition. Details regarding 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 the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (eg, the RPT device 4000 and the patient interface 3000).

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

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

[0088] 5.6 Two-way communication for personalized treatment and / or coaching In one form of the technology, the medical device (e.g., RPT device) may include bidirectional communication with one or more remote processing systems for facilitating personalized coaching programs, customized 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. The 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 analytics and provide personalized solutions to the medical device. These personalized solutions include personalized coaching programs for improved engagement and motivation, personalized treatments including comfort through automation and / or treatment setting updates for improved long-term adherence, and / or targeted care and follow-up based on identification of patients in need of assistance. Patient segmentation and advanced analytics may include machine deep learning using data from other users and one or more training models to provide personalized solutions.

[0089] In contrast to conventional systems that require preloading of medical device settings and highly trained technicians to change the settings of medical devices, examples of the technology allow the medical device to be automatically configured after it is deployed for use. Accurate determination of medical device settings and recommendations for patients can be made remotely and quickly, without the need for clinicians to repeatedly change device settings (until the patient feels comfortable using the medical device). In addition, feedback received from users and medical device settings can be used to improve settings of other medical devices and provide relevant recommendations to other patients.

[0090] FIG. 4G is a diagram of a communication system between an RPT device 4000 and a remote computing system. FIG. 4G includes one or more RPT devices 4000 associated with a patient 1000. The 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, a cell phone, a tablet, and / or a 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 over 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 by appropriately authorized parties (e.g., a clinician, a manufacturer, and / or a device supplier). As shown in FIG. 4G, the RPT device 4000 may also communicate with remote computing systems including a server 6030 and / or a 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 the remote external device 4286, the server 6030 and / or the cloud computing platform 6040.

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

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

[0094] FIG. 4H illustrates exemplary operations performed by the RPT device 4000 and a remote computing system in accordance with one embodiment of the present technology. Although FIG. 4 illustrates operations performed by specific devices, these operations are not limited thereto. One or more operations may be performed by the PT device 4000 and / or other devices operatively connected to 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., the local external device 4288).

[0095] The RPT device 4000 may be configured to perform a setup of the RPT device 4000 (step 7010). This setup may include associating a 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 the operations are disclosed in U.S. Provisional Application No. 62 / 749,430, filed October 23, 2018, entitled "SYSTEMS AND METHODS FOR SETUP OF CPAP SYSTEMS" and U.S. Application No. 16 / 661,250, filed October 23, 2019, entitled "SYSTEMS AND METHODS FOR SETUP OF CPAP SYSTEMS," both of which are incorporated herein by reference in their entirety. One or more of these operations may be performed during setup of the RPT device 4000.

[0096] Setup may occur when the RPT device 4000 is powered on for the first time after purchase or after a reset, or when the RPT device 4000 is assigned to a new patient. Setup may occur without user interaction by applying settings for the RPT device 4000 stored in memory (e.g., memory 4260 or memory external to 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 by utilization of 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 setup of the RPT device 4000. Display screens may be generated on the RPT device 4000 and / or external devices to request patient input during setup of the device. In some examples, voice instructions and / or audible responses may be received by the RPT device 4000 and / or local external device 4288. In some examples, data entry by the user and / or personalized coaching programs, customized treatments and / or targeted care and follow-up (e.g., provided in response to the entered data) may be provided via a range of different mechanisms (e.g., application, web, email, phone).

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

[0099] After one or more predefined conditions are met, a feedback request may be displayed to the patient (step 7018). This feedback request may be displayed (e.g., within an application) on the display 4294 or the device and / or the local external device 4288. 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 predefined conditions are met. The feedback is not limited to demographic and subjective feedback, but may include further questions. The feedback, demographic and / or subjective feedback may include sleep study results, symptoms, co-morbidities or other health information (e.g., presence of other sleep issues (e.g., insomnia)), knowledge level about sleep apnea, comfort level in starting treatment, stage in the journey (new to treatment or already experienced user) and / or motivation.

[0100] Examples of the specified conditions include a predetermined period of time that has elapsed since the RPT device 4000 was set up, the patient reaching a specified goal (e.g., use of the device for a predetermined period of time (e.g., a pre-set number of hours, days, or weeks)), use of a particular feature suggested by the RPT device 4000 (e.g., operating the device in a low power mode 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 remote computing system or a device operated by a clinician, receiving a feedback request from another device, setting a flag indicating that a feedback request is available for display to the patient, and / or receiving a notification that a feedback request is available for download.

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

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

[0103] The introductory screens 7050 and 7052 may include introductory text, graphics and / or video with information for introducing the system, components and / or treatment personalization features to the patient. The introductory screen 7050 may be displayed for a predetermined period of time and then auto-transition to the display screen 7052. The display screen 7052 may provide the user with a selectable option to continue responding to the displayed feedback request or to skip the personalization features of the RPT device 4000. In some examples, instead of or in addition to skipping the personalization features, the user may be provided with the option to provide the information later. The introductory screens 7050 and / or 7052 may be displayed only the first time the user powers on the unit (e.g., after purchasing or resetting the unit) or may be displayed a predetermined number of times until customization information is received.

[0104] Display screen 7054 shows an option for the patient to select their gender. The patient may be provided with a selectable option to skip the feedback request, as shown in display screen 7054. One or more of the other feedback requests may also include an option to skip the reply request.

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

[0106] Display view 7058 shows an option to enter the patient's height, and display view 7060 shows an option to enter the patient's weight.

[0107] Display screen 7062 shows a question about whether the patient has previously used the RPT device 4000. In some examples, the question may include providing a number of other RPT devices the patient has used or providing a level of expertise the patient believes they have in using the RPT device 4000 on a predefined scale.

[0108] Display screen 7064 shows questions to assess how sleepy the patient typically feels during the day. The user may be given different scales between "not sleepy" and "very sleepy". Other subjective feedback questions include sleep regularity, sleep satisfaction, sleep alertness, sleep timing, sleep efficiency and / or sleep length. These questions may include: "Do you often wake up at roughly the same time each day (within an hour)?", "How often do you sleep satisfactorily?", "How often are you able to stay awake throughout the day without dozing or napping?", "During the period 2am-4am, during your typical nighttime sleep, do you typically wake up for less than 39 minutes?", and / or "Do you typically sleep between 6-8 hours per day?". A sliding scale and / or multiple selectable responses (e.g., "almost never", "sometimes", and "all the time") may be given for one or more of the responses to these questions.

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

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

[0111] Other feedback requests that may be included in other display screens include the level of how well the patient slept through the night, the comfort level of the mask, breathing comfort when using CPAP, and / or satisfaction level with the operation of the device. In some examples, a subjective question (e.g., sleep comfort) may be received multiple times, each over a different period of time. For example, the RPT device 4000 may be configured to request the patient to provide feedback on sleep comfort over a given number of days (e.g., 7 days).

[0112] The display screen requesting feedback may include an option to select that the response is unknown and / or may provide an option to retrieve information from an external source (e.g., a database, a physician's records, an external device, etc.).

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

[0114] In one form of the present technology, a display screen containing a feedback request may be displayed on a touch input display. In one form of the present technology, inputs to questions displayed on the display may be entered using one or more input devices 4220 (e.g., physical buttons, switches or dials, or software devices accessible via a touch screen).

[0115] In one form of the present technology, feedback requests may be audibly output to the patient using a speaker and / or verbal feedback responses may be captured via a microphone.

[0116] After responses to the feedback requests are received, these responses may be stored in memory and / or transmitted to the remote computing system (step 7022). In one form of the present technology, the data may be transmitted 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 form of the present technology, if a connection to the remote computing system is unavailable, the feedback data may be stored in memory 4260 until a connection is available.

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

[0118] The remote computing system receives the data (step 7024), analyzes the data (step 7026), and transmits the analysis results to the RPT device 4000 and / or the web 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. The server 6030 may be a non-cloud based server managed by the manufacturer or clinician.

[0119] The remote computing system may break down patient data (e.g., age range, gender, weight, environment) and use models developed using similar and / or different data from other users to determine what the patient needs and / or what 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 the other patients 1002 and / or 1004. Advanced analytics, artificial intelligence, and / or machine learning may be performed on data from multiple patients, and these models may be updated with new data as it becomes available (e.g., data including demographic feedback, subjective feedback, and / or changes to compliance standards). Results of these analyses include personalized coaching programs, tailored treatments, and / or targeted care and follow-up.

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

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

[0123] The personalized therapy may result in automated comfort settings (which have been shown to improve long term adherence (LTA)). The personalized therapy may be automatically applied to the RPT device 4000 without patient interaction. In some examples, the patient may be informed about the therapy changes and requested to accept the proposed changes (before they are applied).

[0124] Targeted care and follow-up may include notifying a patient in need that they need to make a change in care or schedule an appointment with a clinician or another specialist. In some examples, the RPT device 4000 and / or the local external device 4288 may be used to schedule and / or conduct an appointment with a clinician or other specialist.

[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 slope setting, the expiratory relief setting, the humidity setting, and the air temperature setting. In one form of the present technology, the analysis results may indicate that continued use of the RPT device 4000 is not safe and therefore use of the RPT device 4000 may be disabled.

[0126] After applying these analysis results, operation of the RPT device 4000 may continue (step 7034). By applying the analysis results and operating the RPT device 4000 with updated settings, the RPT device 4000 is controlled more efficiently to meet the needs of the patient. In some examples, these changes may be made to make the device operate more efficiently (e.g., using less power or running cooler heated tubes delivering air) without significantly sacrificing patient comfort.

[0127] After a predetermined time, one or more of the previously made feedback requests and / or a new feedback request 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 valid and / or whether further changes in the operation and / or use of the RPT device 4000 are required. Further feedback requests may be made periodically or when a new feedback request by the remote computing system becomes available.

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

[0129] In one form of the technology, some 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 requested on other devices because the request is being displayed.

[0130] In one form of the present technology, operations related to displaying feedback requests and receiving feedback request input may occur at device set-up (step 7010).

[0131] FIG. 4J shows another example of operations performed by the RPT device 4000 and a remote computing system. In the example shown in FIG. 4H, the feedback request data was pre-stored on the RPT device 4000. For example, the feedback request data may be pre-stored in memory by a manufacturer, distributor, or clinician. In the example shown in FIG. 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 that transmits the feedback request data may be a system separate from the system that performs the analysis using the demographic and / or subjective feedback data transmitted from the RPT device 4000.

[0132] The remote computing system may send the 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 regular predetermined intervals or on an ad-hoc basis (either directly or through a home medical device).

[0133] The input of the feedback request data may be performed by a physician or clinician. The physician or clinician may be provided with a user interface to input his or her own questions as part of the feedback request data. The physician or clinician may be provided with the ability to ask his or her own questions to the patient 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 use a remote computing system to input the questions. 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, tubing), and / or device operating parameters.

[0134] FIG. 4K is a data flow diagram in a system that provides communication between a medical device (eg, an RPT device 4000), a patient portal 8030 and a patient demographics service 8010.

[0135] The patient demographic survey service 8010 may run on one or more servers (which may include the cloud and / or specialized servers (e.g., server 6030)). The patient demographic survey service 8010 may coordinate the management and communication of questions and answers for demographic and subjective feedback. As shown in FIG. 4K, the patient demographic survey service 8010 may support sending questions to a patient account associated with a medical device. The patient account may be accessed via a web or mobile application running on the local device 4288 or via the RPT device 4000. The patient account accessed via the web or mobile application may provide monitoring, reporting and / or configuration of the medical device and coaching for the patient.

[0136] The Patient Demographics Service 8020 may notify the client that a question is available. A question may be available when a question has been added to a content management system (e.g., by marketing). These questions may be retrieved from the Patient Demographics Service 8020 via a GET call. In one example, when a patient's account is accessed via a web or mobile application, a home may be called and a question retrieval may be done via a proxy through the Patient Portal 8030. These questions may be provided in JavaScript Object Notation (JSON) format, showing the content of the question and possible answers. The question submission may be embedded in the application as HTML content. When a patient's account is accessed via a web or mobile application, the answers may be sent back to the Patient Demographics Service 8020 via a proxy through the Patient Portal 8030 (e.g., via a POST instruction).

[0137] The medical device may call home, get a question through the MCS device 8024 via a proxy, and send the answer (e.g., via a POST instruction) through the MCS device 8024 via a proxy to the patient demographics service 8020. The GET call may include the medical device's serial number for the patient demographics service 8010 (to track which questions were sent to which devices and / or applications).

[0138] According to one embodiment, the patient demographics service 8010 may moderate questions so that they are available to the patient portal after a predetermined period of time (e.g., 48 hours), thereby minimizing duplicate questions being asked.

[0139] According to another aspect, the patient demographic survey service 8010 may moderate questions so that questions that a patient has already answered are not displayed again. In one example, the patient demographic survey service 8010 may track questions that have been answered on one platform (e.g., a medical device) and not display those questions on the patient's account accessed via a web application or a mobile application.

[0140] Responses to the questions may be received by the Patient Demographics Service 8010 from the patient's account accessed via a medical device or a web or mobile application. These responses may be sent to the cloud computing platform 6040 for advanced analytics. The cloud computing platform may include an analytics data lake with data from many other patients. Deep neural networks may be used to build models and analyze the received responses. In some examples, the Patient Demographics Service 8010 may place the received responses in a queue for advanced analytics consumption.

[0141] The patient demographics service 8010 may support providing questions and / or answers to the remote patient monitoring system. Remote monitoring may be provided via a web or mobile application running on the remote external device 4286. Remote monitoring may provide a secure cloud-based patient management system for online patient monitoring, allowing clinicians to quickly access patient data, share clinical insights with other health professionals, and reduce costs associated with patient follow-up. Remote monitoring may receive medical device operation information, compliance information, device settings, changes in device settings, questions posed to the patient and / or answers received from the patient. Clinicians may use data obtained from remote monitoring to suggest further changes to the patient's coaching program and / or personalized treatment.

[0142] The Patient Demographics Service 8010 may support receiving initial hard-coded questions from the medical device. At the time of manufacture, the initial questions may be loaded into the medical device. The medical device may pose the initial questions and receive responses to the questions upon setup or when a predetermined condition is met (e.g., after the medical device has been used for a predetermined period of time or after a predetermined period of time has passed since setup). These initial questions may be sent from the medical device to the Patient Demographics Service 8010 for distribution to remote monitoring and / or web or mobile applications. In some examples, if the initial questions are not answered on the medical device, the initial questions may be made available via a web or mobile application. The Patient Demographics 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 by the manufacturer to the patient demographics service 8010. In this example, the patient demographics service 8010 may receive the identification information (e.g., serial number) of the medical device 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 features provided by the device.

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

[0145] 5.6.1 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (eg, upstream of the pneumatic block 4020), the pneumatic circuit 4170 and / or the patient interface 3000.

[0146] 5.7 Humidifier In one form of the present 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 (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airway.

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

[0148] According to one arrangement, the reservoir 5110 may include a conductive region 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 FIG. 5B ) configured to receive the humidifier reservoir 5110 with a locking lever 5135 configured to hold the reservoir 5110 and / or a water level indicator 5150 (as shown in FIGS. 5A-5B ), and / or one or more humidifier transducers (e.g., a sensor) instead of or in addition to the transducer 4270 described above. 5C 。 The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5C . The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., the central controller 4230 and / or the humidifier controller 5250). In some forms, the humidifier transducer may be located outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signals to the controller.

[0149] According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250 as shown in FIG. 5C. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that may be in communication with the central controller 4230.

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

[0151] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240).

[0152] Examples of humidifier components are described in PCT application PCT / AU2014 / 050426 (WO2015089582), which is incorporated herein by reference.

[0153] 5.8 Respiratory Pressure Therapy Mode Depending on the values ​​of parameters A and P0 in the treatment pressure equation (1) used by the treatment parameter determination algorithm 4329 in one form of the present technology, various respiratory pressure treatment modes may be performed by the RPT device 4000.

[0154] 5.8.1 CPAP treatment In some implementations of this form of the technology, the amplitude A is equal to zero, so that the therapeutic pressure Pt is equal to the base pressure P0 throughout the entire respiratory cycle. Such implementations are primarily grouped under the heading of CPAP therapy. In such implementations, the therapy engine module 4320 is not required to determine the phase Φ or waveform template Π(Φ). 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. The method 4500 then returns to step 4520. In one implementation, the decrement is proportional to the value of P0-Pmin, so that in the absence of a detected event, the reduction of P0 to the minimum therapeutic pressure Pmin is exponential. In one implementation, the constants of the proportionality are 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 implementations, the minimum therapeutic pressure Pmin can be as low as 0 cmH2O and as high as 8 cmH2O, or as low as 2 cmH2O and as high as 6 cmH2O. Alternatively, the decrement of P0 may be predetermined such that the decrease of P0 to the minimum therapeutic pressure Pmin in the absence of a detected event is linear.

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

[0156] In some forms of bilevel therapy, IPAP is the same therapeutic pressure of interest as the therapeutic pressure in CPAP therapy mode, and EPAP is IPAP minus amplitude A, which has a "small" value (a few cmH2O), also called expiratory pressure release (EPR). Such forms are also called CPAP therapy with EPR, and are generally considered to be more comfortable than direct CPAP therapy. In the case of CPAP therapy with EPR, either or both of IPAP and EPAP may be constant values, hard-coded or manually entered into the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate IPAP and / or EPAP during CPAP with EPR. In this alternative, the therapy parameter determination algorithm 4329 iteratively calculates EPAP and / or IPAP as a function of the index or measurement of sleep disorder breathing 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 that the RPT device 4000 performs some or all of the work of breathing for the patient 1000. In such forms, known as pressure support ventilation therapy, the amplitude A is referred to as pressure support or swing. In pressure support ventilation therapy, IPAP is the base pressure P0 plus pressure support A, and EPAP is the base pressure P0.

[0158] In some forms of pressure support ventilation therapy, known as constant pressure support ventilation therapy, the pressure support A is fixed at a predetermined value (e.g., 10 cmH2O). The predetermined pressure support value is a setting of the RPT device 4000 and may be set, for example, by hard-coded during configuration of the RPT device 4000 or by manual entry via the input device 4220.

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

[0160] In some forms of servo ventilation, the therapy parameter determination algorithm 4329 applies a control method that iteratively calculates the pressure support A to drive the current measurement of the respiratory parameter towards a target value. One such control method is proportional-integral (PI) control. In one implementation of PI control suitable for ASV mode, where the target ventilation Vtgt is set to be slightly lower than the typical recent ventilation Vtyp, the pressure support A is iteratively calculated as follows:

number

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

[0162] The value of pressure support A calculated via equation () may be clipped to a range defined as [Amin, Amax]. In this embodiment, pressure support A defaults to minimum pressure support Amin until the current ventilation Vent is measured below the target ventilation Vtgt. At that point A begins to increase, decreasing back to Amin only if Vent again exceeds Vtgt.

[0163] The pressure support limits Amin and Amax are settings of the RPT device 4000 and are set, for example, by hard-coded during configuration of the RPT device 4000 or by manual entry through the input device 4220.

[0164] In the pressure support ventilation treatment mode, the EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP treatment, the EPAP may be a constant value, defined or determined during titration. Such a constant EPAP may be set, for example, by hard-coding during configuration of the RPT device 4000 or by manual input through the input device 4220. This alternative is also referred to as fixed EPAP pressure support ventilation treatment. The titration of the EPAP for a given patient may be performed by a clinician during a titration session with PSG for the purpose of preventing obstructive apnea, thereby maintaining an open airway for pressure support ventilation treatment in a manner similar to the titration of the base pressure P0 in constant CPAP treatment.

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

[0166] 5.9 Glossary For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply.

[0167] 5.9.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to combinations of other breathable gases (e.g., oxygen-rich atmospheric air).

[0168] Environment: In certain forms of the present technology, the term "environment" should be taken to mean: (i) that which is external to the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.

[0169] For example, the environmental humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room in which the patient sleeps). Such environmental humidity may differ from the humidity outside the room in which the patient sleeps.

[0170] In another example, the environmental pressure may be the pressure immediately surrounding or external to the body.

[0171] In certain embodiments, environmental (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Environmental noise can originate from sources outside the room.

[0172] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that is capable of automatically adjusting therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0173] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airway increases slightly during expiration and decreases slightly during inspiration. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0174] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, references to flow rate refer to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, references to flow rate refer to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be called "flow" or "airflow" for shorthand.

[0175] In the example of a patient's breath, the flow rate may be nominally positive for the inhalation portion of the patient's breathing cycle, and therefore negative for the exhalation portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Ventilator flow rate Qv is the flow rate of air exiting the vent to allow for the outflow of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0176] Humidifier: The word "humidifier" is to be construed as meaning a humidification device constructed, arranged or configured with a physical structure capable of providing a therapeutically beneficial quantity of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0177] Leakage: The term "leakage" is taken as an unintended air flow. In one embodiment, a leak may occur due to an imperfect seal between the mask and the patient's face. In another embodiment, a leak may occur at the elbow to the perimeter.

[0178] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic path (e.g., the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0179] Noise Emission (Acoustic): In this document, radiated noise refers to noise that is carried by the surrounding air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target according to ISO 3744.

[0180] Ventilation Noise (Acoustic): In this document, ventilation noise refers to the noise generated by airflow through any vents (eg, vents in a patient interface).

[0181] Patient: A person with or without respiratory disease.

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

[0183] The pressure in the patient interface is given the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this moment, is given the symbol Pt.

[0184] Respiratory Pressure Therapy (RPT): The application to the airway inlet of an air supply at therapeutic pressure, which is typically positive relative to the environment.

[0185] Ventilator: A mechanical device that provides pressure support to a patient during some or all of the work of breathing.

[0186] 5.9.2 Breathing cycle Apnea: According to some definitions, apnea is said to occur when flow below a certain threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0187] Respiratory Rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0188] Duty Cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0189] Effort (Respiration): Respiratory effort is said to refer to the movement made by a person's spontaneous breathing in an attempt to breathe.

[0190] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0191] Flow limitation: Flow limitation is understood to be a situation in a patient's breathing where an increase in effort by the patient does not cause a corresponding increase in flow rate. If the flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation may be referred to as inspiratory flow limitation. If the flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation may be referred to as expiratory flow limitation.

[0192] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat area and then a downswing. (ii) M-shaped: has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat region between the two peaks. (iii) Chair-like: Has a single local peak that occurs at the rising edge and is followed by a relatively flat region. (iv) Inverted chair shape: A relatively flat region is followed by a single local peak, which occurs on the trailing edge.

[0193] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when there is a sustained period of reduced flow below a threshold rate. When hypopnea is detected due to a reduction in respiratory effort, central hypopnea is said to occur. In one form in adults, hypopnea may be considered when any of the following occur: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction in patient respiration (less than 50%) lasting for at least 10 seconds and associated with at least 3% desaturation or arousal occurs.

[0194] Hyperventilation: An increase in flow to a level higher than normal.

[0195] Inspiration portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiration portion of the respiratory cycle.

[0196] Patency (Airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Airway patency may be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

[0197] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0198] Peak flow (Qpeak): The maximum value of flow during 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 RPT device's estimate of respiratory airflow and are used in contrast to "true respiratory flow" or "true respiratory airflow", which is the patient's actual respiratory flow, usually expressed in liters / minute.

[0200] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume V i (volume of inhaled air) is the expiratory volume V e (volume of exhaled air), so a single tidal volume V t can be defined as being equal to either quantity. In practice, the tidal volume V t is some combination (e.g., intake volume V i and expiratory volume V e It is estimated as the average of

[0201] (Inspiration) 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: The ventilation value around which the most recent values ​​of ventilationVent tend to cluster over a given time scale (i.e., the degree to which the most recent values ​​of ventilation tend to be central).

[0205] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).

[0206] Vent: A measurement of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inhaled and exhaled airflow per unit of time. When expressed as volume per minute, this amount is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and is understood as volume per minute. 5.10 Other Notes

[0207] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the reproduction by any person of this patent document or the patent disclosure by facsimile, for purposes of disclosure in the Patent and Trademark Office patent file or records, but reserves all copyright rights thereto for all other purposes.

[0208] Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value between the upper and lower limits of the range, the unit of the lower limit, and any other stated or intervening value of the stated range is encompassed by the technology. The upper and lower limits of these intervening ranges, which are independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0209] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise indicated, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0210] Unless otherwise specified, all technical and scientific terms herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0211] Although particular materials are described as being preferred for use in the construction of components, obvious alternative materials having similar properties may be substituted. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

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

[0213] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. Publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0214] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps that are not specifically described.

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

[0216] Although the technology herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are not necessary for the practice of the technology. For example, the terms "first" and "second" (and the like) are used, but unless otherwise specified, these terms are not intended to indicate any order, but are used to distinguish separate elements. Furthermore, although the description or illustration of the process steps in the method may be described in an order, such order is not required. Those skilled in the art will recognize that such order can be changed and / or aspects can be performed simultaneously or even synchronously.

[0217] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0218] 5.11 Explanation of symbols 1000 patients 1002 Other patients 1004 Other patients 1100 Bedmate 3000 Patient Interface 4000 RPT Devices 4010 Outer Housing 4012 Upper 4014 parts 4015 Panel(s) 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet Air Filter 4120 Muffler 4122 Inlet muffler 4124 Exit 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 Device 4230 Central Controller 4232 Watch 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 communications network 4286 Remote External Device 4288 local foreign device 4290 output device 4292 Display Driver 4294 Display 4300 Algorithm 4310 Pre-processing module 4312 Pressure Compensation Algorithm 4314 Estimation of ventilation flow rate 4316 Estimation of leakage flow rate 4316 Estimation of leakage flow rate 4318 Respiratory flow estimation 4320 Treatment Engine Module 4321 Phase Determination Algorithm 4322 Waveform Determination Algorithm 4323 Ventilation Decision Algorithm 4324 Inspiratory Flow Limitation Decision Algorithm 4325 Apnea / hypopnea decision algorithm 4326 Snoring Determination Algorithm 4326 Snoring Determination Algorithm 4326 Snoring Determination Algorithm 4327 Airway Patency Determination Algorithm 4328 Target ventilation decision algorithm 4329 Treatment Parameter Decision Algorithm 4330 Treatment Control Module 4340 Algorithm 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 Lock 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 Foreign 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 Step 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 services 8020 Patient statistics survey services 8024 MCS Device 8030 Patient Portal

Claims

1. 1. A respiratory pressure therapy system for providing continuous positive airway pressure (CPAP) to a patient, comprising: a flow generator configured to generate a supply of breathable gas for delivery to a patient, the breathable gas being output from the flow generator at a pressure level above environmental pressure; at least one sensor configured to measure a physical quantity while the breathable gas is being delivered to a patient; a computing device including a memory and at least one hardware processor, said computing device comprising: receiving sensor data from the at least one sensor based on a measured physical characteristic of the supply of breathable gas; controlling the flow generator based on the received sensor data to adjust characteristics of the supply of breathable gas delivered to a patient; displaying on a display device one or more questions relating to demographic and / or subjective feedback; receiving one or more inputs in response to displaying the one or more questions, the inputs indicating answers to the one or more questions; transmitting the response to a remote processing system; receiving from the remote processing system settings of the respiratory pressure treatment system determined based on the transmitted response; and adjusting control settings of the respiratory pressure treatment system based on the received settings.

2. 10. The respiratory pressure treatment system of claim 1, wherein the remote processing system is an on-demand cloud computing platform configured to perform machine learning using data received from multiple patients.

3. The respiratory pressure treatment system of claim 1 or 2, wherein the questions are pre-stored in the memory.

4. The respiratory pressure treatment system of any one of claims 1 to 3, wherein the one or more queries are received from the remote processing system.

5. The respiratory pressure treatment system of any one of claims 1 to 4, further comprising a patient interface configured to engage at least one airway of the patient and to supply breathable gas to the patient.

6. The respiratory pressure treatment system of any one of claims 1 to 5, wherein the questions include at least one question related to demographic information about the patient and at least one question related to subjective feedback from the patient regarding use of the respiratory pressure treatment system.

7. 7. The respiratory pressure treatment system of claim 1, further comprising a remote processing system configured to determine a personalized coaching program for the patient based on the answers transmitted to the remote processing system.

8. 7. The respiratory pressure treatment system of any one of claims 1 to 6, further comprising the remote processing system, the remote processing system configured to determine a customized treatment for the patient based on the response transmitted to the remote processing system.

9. The respiratory pressure treatment system of any one of claims 1 to 8, wherein the computing device is further configured to perform a set-up operation, and the one or more questions are displayed after set-up and after a predetermined condition is met.

10. 10. The respiratory pressure treatment system of claim 9, wherein the predetermined condition comprises a predetermined period of time elapsed after setup.

11. The respiratory pressure treatment system of any one of claims 1 to 9, wherein the settings of the respiratory pressure treatment system and / or the personalized coaching program are received by an application, website, email, and / or mobile device associated with the patient.

12. 1. An apparatus for treating disordered breathing in a patient, comprising: A display device; a pressure generator configured to generate an airflow for treating said respiratory disorder; a transducer configured to generate a flow signal indicative of a characteristic of the air flow; a controller coupled to the display, the pressure generator, and the transducer, the controller comprising: receiving the flow signal from the transducer; controlling the pressure generator to adjust a characteristic of the air flow based on the received flow signal; displaying a request for demographic and / or subjective feedback on said display device; and receiving one or more inputs indicative of demographic and / or subjective feedback in response to said request; transmitting demographic and / or subjective feedback data determined based on the received one or more inputs to a remote processing system; and receiving from the remote processing system an analysis result determined based on the transmitted demographic and / or subjective feedback data; and adjusting control settings of the device based on the received analysis results.

13. The apparatus of claim 12 , wherein the controller, the display and the pressure generator are co-housed.

14. 14. The apparatus of claim 12 or 13, wherein the adjusted control setting comprises a therapeutic pressure provided in a patient mask connected to the pressure generator.

15. The device of any one of claims 12 to 14, wherein the controller is configured to transmit operational data of the device together with the demographic and / or subjective feedback data, and the analysis result is determined based on the demographic and / or subjective feedback data and the operational data of the device.

16. The apparatus of any one of claims 12 to 15, wherein the analysis results include a personalized coaching program for the patient.

17. The apparatus of any one of claims 12 to 16, wherein the analysis results include a personalized treatment for the patient.

18. 1. A method of operating a respiratory treatment device to generate an airflow for the treatment of a respiratory disorder, comprising: measuring a characteristic of the air flow with a transducer; calculating in the controller a result based on the measured characteristics, the result including at least one of a respiratory event, a cardiorespiratory characteristic of the patient, and a physical condition of the patient; controlling in the controller an adjustment of the airflow characteristics based on the result; displaying one or more questions relating to demographic and / or subjective feedback; receiving, in response to displaying the one or more questions, one or more inputs at the controller indicative of answers to the one or more questions; transmitting the response to a remote processing system; and receiving from the remote processing system settings for operation of the respiratory treatment device and / or personalized coaching program for the patient based on the response transmitted to the remote processing system.

19. 20. The method of claim 18, further comprising adjusting control settings of the respiratory treatment device based on the received settings.

20. 20. The method of claim 18 or 19, wherein settings for operation of the respiratory treatment device provide a customized therapy to the patient determined based on the answer and control settings of the respiratory treatment device transmitted to the remote processing system upon receipt of an input indicative of the answer.

21. The method according to any one of claims 18 to 20, wherein the question is displayed on a display of the respiratory treatment device.

22. The method according to any one of claims 18 to 20, wherein the questions are displayed on a mobile device configured to run an application for control of the respiratory treatment device.

23. The method according to any one of claims 18 to 22, wherein the question is displayed after a predefined condition is met.

24. 24. The method of claim 23, wherein the predetermined condition comprises a predetermined period of time after the respiratory treatment device has been set up and / or a predetermined period of time the respiratory treatment device has been operated by a patient.

25. 1. A processing system comprising: a memory for storing a plurality of demographic questions and a plurality of objective questions; a computing system including at least one hardware processor coupled to the memory, the computing system comprising: transmitting at least one demographic question and at least one objective question stored in said memory to a medical device associated with the patient; receiving from the medical device answers to the at least one demographic question and the at least one objective question transmitted to the medical device; sending a notification to a mobile device configured to execute an application for communication with the medical device indicating that an unanswered question exists; receiving a request for the question from the mobile device; in response to the request, transmitting at least one demographic question and at least one objective question stored in the memory to the mobile device; receiving from the mobile device responses to the at least one demographic question and the at least one objective question transmitted to the mobile device; and (2) performing advanced analytics to determine an individualized coaching program and customized treatment for the patient using the medical device based on the responses received from the medical device and the mobile device and (3) the responses received from a plurality of other medical devices.

26. 26. The processing system of claim 25, wherein the medical device is a respiratory treatment machine.

27. 27. The processing system of claim 25 or 26, wherein the computing system is further configured to receive from the medical device answers to questions pre-stored in and answered using the medical device.

28. The processing system according to any one of claims 25 to 27, wherein the query is sent to the mobile device and / or the medical device after a predefined condition is met.

29. 30. The processing system of claim 28, wherein the predetermined condition is a predetermined period of time after the medical device has been set up and / or a predetermined period of time that the medical device has been operated by a patient.

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