Respiratory pressure therapy system, apparatus for treating a respiratory disorder in a patient, and processing system

Abstract

Two-way communication in a medical device. The present invention relates to a system for providing continuous positive airway pressure therapy. The system includes a flow generator, a sensor, and a computing device. The computing device is configured to control the operation of the flow generator based on sensor data. The computing device is further configured to display, on a display device, one or more questions relating to demographic and / or subjective feedback; in response to the display of one or more questions, receive one or more inputs indicating answers to one or more questions; transmit the answers to a remote processing system; receive, from the remote processing system, settings determined based on the transmitted answers and adjust system control settings based on the received settings.

Description

1 / 67 Respiratory pressure therapy system, device for treating a respiratory disorder in a patient, and processing system. CROSS-REFERENCE TO RELATED REQUESTS

[001] This request claims priority over Provisional Request No. US 62 / 848,991, filed on May 16, 2019, the full content of which is incorporated herein by reference. BACKGROUND OF THE TECHNOLOGY 2.1 FIELD OF TECHNOLOGY

[002] The present technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention and improvement of respiratory-related disorders. The present technology also relates to medical devices or apparatus, and their use and, more particularly, to methods and systems for configuring medical devices and providing individualized training and / or personalized therapy for patients using medical devices. 2.2 DESCRIPTION OF THE RELATED TECHNIQUE 2.2.1 The Human Respiratory System and its Disorders

[003] The body's respiratory system facilitates gas exchange. The nose and mouth form the entry points to a patient's airways.

[004] The respiratory tract includes a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The main function of the lung is gas exchange, allowing oxygen to move from inhaled air to venous blood and carbon dioxide to move in the opposite direction. The trachea divides into the right and left main bronchi, which eventually divide further into Petition 870260055359, dated 08 / 06 / 2026, page 10 / 176 2 / 67 terminal bronchioles. The bronchi compensate for the conduction of the airways and do not participate in gas exchange. Further divisions of the airways lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lung is where gas exchange occurs and is called the respiratory zone. See 'Respiratory Physiology', by John B. West, Lippincott Williams & Wilkins, 9th edition published in 2012.

[005] A variety of respiratory disorders exist. Certain disorders can be characterized by particular events, for example, apneas, hypopneas, and hyperpneas.

[006] Examples of respiratory disorders include Apnea Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory failure, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and chest wall disorders.

[007] Obstructive Sleep Apnea (OSA), a form of Sleep Disorder Sleep-Disordered Breathing (SDB) is characterized by events that include occlusion or obstruction of the upper airway during sleep. This results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This generally causes excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in overweight middle-aged men, although an affected individual may be unaware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[008] Cheyne-Stokes respiration (CSR) is another form of disorder Petition 870260055359, dated 08 / 06 / 2026, page 11 / 176 3 / 67 Sleep-disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of increased and decreased ventilation known as CSR cycles. CSR is characterized by repetitive deoxygenation and reoxygenation of arterial blood. CSR may be harmful due to repetitive hypoxia. In some patients, CSR is associated with repetitive sleep stimulation, resulting in severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

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

[0010] A patient with respiratory failure (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0011] Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness, in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

[0012] Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to airflow, an extended expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (the main risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: shortness of breath on exertion, chronic cough, and sputum production. Petition 870260055359, dated 08 / 06 / 2026, page 12 / 176 4 / 67

[0013] Neuromuscular Disease (NMD) is a broad term encompassing many diseases and conditions that impair muscle function, either directly through intrinsic muscle pathology or indirectly through nerve pathology. Some patients with NMD are characterized by progressive muscle weakness leading to loss of ambulation, confinement to a wheelchair, swallowing difficulties, respiratory muscle weakness, and eventually death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterized by muscle deterioration that worsens over months and results in death within a few years (e.g., Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) Variable or slowly progressive disorders: Characterized by muscle deterioration that worsens over the years and only slightly reduces life expectancy (e.g., Limb Modeler, Facioscapulohumeral, and Myotonic Muscular Dystrophy). Symptoms of respiratory failure in NMD include: increasing generalized weakness, dysphagia, dyspnea on exertion and at rest, fatigue, drowsiness, morning headaches, and difficulties with concentration and mood changes.

[0014] Chest wall disorders are a group of chest deformities that result in ineffective coupling between the respiratory muscles and the rib cage. The disorders are generally characterized by a restrictive defect and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, repeated chest infections, morning headaches, Petition 870260055359, dated 08 / 06 / 2026, page 13 / 176 5 / 67 fatigue, poor sleep quality and loss of appetite.

[0015] A range of therapies has been used to treat or improve such conditions. Conversely, otherwise, healthy individuals may benefit from such therapies to prevent respiratory disorders from arising. However, they have various deficiencies. 2.2.2 THERAPY

[0016] Various therapies, such as Airway Pressure therapy Continuous Positive Airway Pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV) were used to treat one or more of the above respiratory disorders.

[0017] Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA with CPAP therapy may be voluntary, and consequently, patients may choose not to consent to therapy if they find the devices used to deliver such therapy to be one or more of the following: uncomfortable, difficult to use, expensive, and aesthetically unappealing.

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

[0019] Invasive ventilation (IV) provides ventilatory support for Petition 870260055359, dated 08 / 06 / 2026, page 14 / 176 6 / 67 patients who are no longer able to breathe effectively on their own may require the use of a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies can be improved. 2.2.3 TREATMENT SYSTEMS

[0020] These therapies can be provided by a treatment system or device. Such systems and devices can also be used to scan, diagnose, or monitor a condition without treating it.

[0021] A treatment system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface and data management. 2.2.3.1 Patient Interface

[0022] A patient interface can be used to interface with respiratory equipment for its user, for example, by providing an airflow to an airway inlet. The airflow can be delivered through a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to a patient's trachea. Depending on the therapy to be applied, the patient interface may form a seal, for example, with a region of the patient's face, to facilitate gas delivery at a pressure sufficiently different from ambient pressure for therapy to be effective, for example, at a positive pressure of approximately 981 Pa (10 cmH2O) relative to ambient pressure. For other forms of therapy, such as oxygen delivery, the patient interface may not include a sufficient seal to facilitate airway delivery of a gas supply at a positive pressure of approximately 981 Pa (10 cmH2O).

[0023] The design of a patient interface presents several Petition 870260055359, dated 08 / 06 / 2026, page 15 / 176 7 / 67 challenges. The face has a complex three-dimensional shape. The size and shape of noses and heads vary considerably between individuals. Since the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The maxilla or mandible can move in relation to other bones of the skull. The entire head can move during the course of a period of respiratory therapy.

[0024] As a consequence of these challenges, some masks are resented for being one or more of the following: intrusive, aesthetically undesirable, expensive, poorly fitting, difficult to use, and uncomfortable, especially when worn for extended periods of time or when a patient is unfamiliar with the system.

[0025] CPAP therapy is highly effective in treating certain respiratory disorders, provided patients are comfortable with the therapy. If a mask is uncomfortable, the wrong size, difficult to use, unsuitable for a particular patient characteristic (e.g., a nasal mask for a mouth breather), or difficult to clean (e.g., difficulty assembling or disassembling), a patient may not be comfortable with the therapy. 2.2.3.2 PRESSURE THERAPY DEVICE Respiratory (RPT)

[0026] A respiratory pressure therapy (RPT) device can be used individually or as part of a system to deliver one or more of the various therapies described above, such as operating the device to generate an airflow for delivery to an airway interface. The airflow may be pressurized. Examples of RPT devices include a CPAP device and a ventilator.

[0027] Air pressure generators are known in a range Petition 870260055359, dated 08 / 06 / 2026, page 16 / 176 8 / 67 of applications, for example, industrial-scale ventilation systems. However, air pressure generators for medical applications have particular requirements not met by more generalized air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical treatment can suffer from shortcomings, belonging to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0028] RPT devices typically comprise a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply an airflow to a patient's airway. In some cases, the airflow may be supplied to the patient's airway at positive pressure. The RPT device output is connected via an air circuit to a patient interface such as those described above.

[0029] A device designer may be presented with an infinite number of choices to make. Design criteria often conflict, meaning that certain design choices are either out of the ordinary or unavoidable. Moreover, the comfort and effectiveness of certain aspects may be highly sensitive to subtle, small changes in one or more parameters. 2.2.3.3 HUMIDIFIER

[0030] Delivering an airflow without humidification can cause airway dryness. The use of a humidifier with an RPT device and patient interface produces humidified gas that minimizes nasal mucosa dryness and increases patient airway comfort. Furthermore, in colder climates, warm air is generally applied to the facial area on and over the patient interface. Petition 870260055359, dated 08 / 06 / 2026, page 17 / 176 9 / 67 is more comfortable than cold air. 2.2.3.4 DATA MANAGEMENT

[0031] There may be clinical reasons for obtaining data to determine whether a patient who has been prescribed respiratory therapy has been compliant, for example, that the patient has used their RPT device in accordance with one or more compliance rules. An example of a compliance rule for CPAP therapy is that a patient, in order to be considered compliant, needs to use the RPT device for at least four hours per night for at least 21 out of 30 consecutive days. In order to determine patient compliance, an RPT device provider, such as a healthcare provider, may manually obtain data describing the patient's therapy with the use of the RPT device, calculate usage over a predetermined time period, and compare it to the compliance rule.Once the healthcare provider has determined that the patient has been using their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0032] There may be other aspects of a patient's therapy that would benefit from communicating therapy data to a third party or external system.

[0033] Existing processes for communicating and managing such data can be one or more of the following: costly, time-consuming, and error-prone. BRIEF SUMMARY OF THE TECHNOLOGY

[0034] The present technology is aimed at providing medical devices used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory disorders that have one or more of the following: improved comfort, cost, effectiveness, ease of use and manufacturability. Petition 870260055359, dated 08 / 06 / 2026, page 18 / 176 10 / 67

[0035] A first aspect of the present technology relates to apparatus used in the scanning, diagnosis, monitoring, improvement, treatment or prevention of a respiratory disorder.

[0036] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, improvement, treatment or prevention of a respiratory disorder.

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

[0038] One embodiment of the present technology comprises a respiratory pressure therapy system configured to present a patient with demographic and / or subjective questions and receive answers to the questions so that the questions can be analyzed to determine settings for the respiratory pressure therapy system.

[0039] Another aspect of a form of the present technology is, for example, through advanced analytics, to determine individualized training programs and / or personalized therapy for a patient based on the patient's responses to demographic and / or subjective questions and / or data from a plurality of other users.

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

[0041] Another aspect of an embodiment of the present technology is presenting demographic and / or subjective questions and receiving responses via a web or mobile application.

[0042] Another aspect of a form of the present technology is to receive answers to demographic and / or subjective questions through a web or mobile application and to use the answers to Petition 870260055359, dated 08 / 06 / 2026, page 19 / 176 11 / 67 Determine settings for the respiratory pressure therapy system.

[0043] Another aspect of a form of the present technology is a processing system that includes memory that stores a plurality of demographic questions and / or a plurality of objective questions and a computing system configured to: transmit objective and / or demographic questions to a medical device and / or a mobile device configured to run an application to communicate with the medical device, receive answers to the questions from the medical device and / or the mobile device, determine, for example, through advanced analysis, based on the answers received, an individualized training program for the patient and / or personalized therapy using the medical device.

[0044] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by an individual who has no medical training, by an individual who has limited dexterity, vision, or by an individual with limited experience in using this type of medical device.

[0045] Another aspect of the present technology is directed to a respiratory pressure therapy (RPT) system for delivering continuous positive airway pressure (CPAP) to a patient. The system comprises: a flow generator configured to generate a supply of breathable gas for delivery to the patient, wherein the breathable gas is emitted from the flow generator at a pressure level that is above atmospheric pressure; at least one sensor that is configured to measure a physical quantity while the breathable gas is supplied to the patient; a computing device that includes memory and at least one hardware processor. The computing device may be configured to: receive, from the patient Petition 870260055359, dated 08 / 06 / 2026, page 20 / 176 12 / 67 minus one sensor, sensor data based on a measured physical property of the breathable gas supply; control, based on the received sensor data, the flow generator to adjust a property of the breathable gas supply delivered to the patient; display, on a display device, one or more questions relating to demographic and / or subjective feedback; in response to the display of one or more questions, receive one or more inputs indicating answers to one or more questions; transmit the answers to a remote processing system; receive, from the remote processing system, settings for the respiratory pressure therapy system determined based on the transmitted answers; and adjust, based on the received settings, control settings of the respiratory pressure therapy system.

[0046] In the 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 setup operations, and one or more questions may be displayed after setup and after a predetermined condition is met, (d) the predetermined condition may include a predetermined amount of time elapsed after setup, (e) the questions may include at least one question regarding demographic information about the patient and at least one question regarding the patient's subjective feedback on the use of the respiratory pressure therapy system,(f) the system may also include a remote processing system and the remote processing system may be configured to determine individualized training programs for the patient based on the transmitted responses, Petition 870260055359, dated 08 / 06 / 2026, page 21 / 176 13 / 67 for the remote processing system, (g) the system may further include the remote processing system and the remote processing system may be configured to determine personalized therapy for the patient based on responses transmitted to the remote processing system, (h) one or more questions may be received from the remote processing system, (i) the system may further include a patient interface configured to fit with at least one of the patient's airways and breathable gas supply to the patient, and / or (j) settings for the respiratory pressure therapy system and / or individualized training programs are received via an application, website, email, and / or mobile device associated with the patient.

[0047] Another aspect of the present technology is directed to an apparatus for treating a respiratory disorder in a patient. The apparatus comprises: a display device; a pressure generator configured to generate an airflow to treat the respiratory disorder; a transducer configured to generate a flow signal representing a property of the airflow; a controller coupled to the display, the pressure generator, and the transducer.The controller can be configured to: receive the flow signal from the transducer; based on the received flow signal, control the pressure generator to adjust an airflow property; display, to the display device, a request for demographic and / or subjective feedback; responsive to the request, receive one or more inputs representing demographic and / or subjective feedback; transmit demographic and / or subjective feedback data determined based on one or more received inputs to a remote processing system; receive, from the remote processing system, analysis results determined based on the transmitted demographic and / or subjective feedback data; and adjust. Petition 870260055359, dated 08 / 06 / 2026, page 22 / 176 14 / 67 based on the analysis results received, device control settings.

[0048] In the examples, (a) the controller, display, and pressure generator may be commonly housed, (b) the adjusted control settings may include a treatment pressure delivered to a patient mask coupled to the pressure generator, (c) the analysis results may include individualized training programs for the patient, (d) the analysis results may include personalized therapy for the patient, (e) the controller may be configured to transmit, along with demographic and / or subjective feedback data, operational device data, and the analysis results may be determined based on the demographic and / or subjective feedback data and the operational device 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 the device has been set up and / or (h) the predetermined condition may be a predetermined period of time that the device has been operated by the patient.

[0049] Another aspect of the present technology is directed to a method for operating a respiratory treatment device to generate an airflow in order to treat a respiratory disorder. The method comprises: measuring an airflow property using a transducer; calculating, in a controller and based on the measured property, a result comprising at least one of: a respiratory event, a cardiorespiratory characteristic of a patient, and a physiological state of the patient; controlling, in the controller, an adjustment for an airflow property based on the result; displaying one or more questions regarding demographic and / or subjective feedback; in response to the display of one or more Petition 870260055359, dated 08 / 06 / 2026, page 23 / 176 15 / 67 questions, receive, in the controller, one or more inputs that indicate answers to one or more questions; transmit the answers to a remote processing system; and receive, from the remote processing system, settings to operate the respiratory treatment device and / or individualized training programs for the patient based on the answers transmitted to the remote processing system.

[0050] In the examples, (a) the method may include adjusting, based on received settings, control settings of the respiratory treatment device, (b) the settings for operating the respiratory treatment device may provide personalized therapy for the patient determined based on responses transmitted to the remote processing system and control settings of the respiratory treatment device at a time when inputs indicating responses are received, (c) questions may be displayed on a display of the respiratory treatment device, (d) questions may be displayed on a mobile device configured to run an application to control the respiratory treatment device, (e) questions 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 has been set up and / or (g) the predetermined condition may be a predetermined period of time that the respiratory treatment device has been operated by the patient.

[0051] Another aspect of the present technology is directed to a processing system comprising: memory that stores a plurality of demographic questions and a plurality of objective questions; a computing system that includes at least one memory-coupled hardware processor, the computing system configured to: transmit, to a medical device Petition 870260055359, dated 08 / 06 / 2026, page 24 / 176 16 / 67 associated with a patient, at least one demographic question and at least one objective question stored in memory; receive, from the medical device, answers to at least one demographic question and at least one objective question transmitted to the medical device; transmit, to a mobile device configured to run an application to communicate with the medical device, a notification indicating that unanswered questions are available; receive, from the mobile device, a request for the questions; in response to the request, transmit, to the mobile device, at least one demographic question and at least one objective question stored in memory; receive, from the mobile device, answers to at least one demographic question and at least one objective question transmitted to the mobile device;and perform advanced analyses to determine, based on (1) responses received from the medical device and mobile device and (2) responses received from a plurality of other medical devices, an individualized patient training program and personalized therapy using the medical device.

[0052] In the examples, (a) the computing system can be further configured to receive, from the medical device, answers to questions pre-stored in the medical device and answered using the medical device, (b) the medical device can be a respiratory treatment device, (c) the questions can be transmitted to the mobile device and / or the medical device after a predetermined condition is met, (d) the predetermined condition can be a predetermined period of time after the medical device is configured and / or (e) the predetermined condition can be a predetermined period of time after the medical device has been operated by the patient. The methods, systems, devices and apparatus described can be deployed in Petition 870260055359, dated 08 / 06 / 2026, page 25 / 176 17 / 67 in order to enhance the functionality of a processor, such as a processor in a special-purpose computer, respiratory monitor and / or respiratory therapy device. Furthermore, the methods, systems, devices and apparatus described may provide improvements in the technological field of automated management, monitoring and / or treatment of respiratory conditions, which include, for example, sleep-disordered breathing.

[0053] Certainly, portions of the aspects may form sub-aspects of the present technology. Moreover, several of the sub-aspects and / or aspects may be combined in various ways and also constitute additional aspects or sub-aspects of the present technology.

[0054] Other technological features will become apparent from consideration of the information contained in the detailed description, summary, drawings and claims that follow. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which similar reference numbers refer to similar elements which include: 4.1 TREATMENT SYSTEMS

[0056] Figure 1 shows a system that includes a patient 1000 wearing a patient interface 3000, in the form of nasal pillows, receiving a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0057] Figure 2 shows a system that includes a patient 1000 wearing a patient interface 3000, in the form of a mask. Petition 870260055359, dated 08 / 06 / 2026, page 26 / 176 18 / 67 nasal, receiving a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000.

[0058] Figure 3 shows a system that includes a patient 1000 wearing a patient interface 3000, in the form of a full-face mask, receiving a positive pressure air supply from a PTR device 4000. The air from the PTR device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleeping position. 4.2 RPT DEVICE

[0059] Figure 4A shows an RPT device according to an embodiment of the present technology.

[0060] Figure 4B is a schematic diagram of the pneumatic path of an RPT device according to an embodiment of the present technology. The upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined as being upstream of the patient interface and the patient interface is defined as being downstream of the blower, regardless of the current flow direction at any particular time. Items located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0061] Figure 4C is a schematic diagram of the electrical components of an RPT device according to an embodiment of the present technology.

[0062] Figure 4D is a schematic diagram of the electrical components of an RPT device according to an embodiment of the present technology. Petition 870260055359, dated 08 / 06 / 2026, page 27 / 176 19 / 67

[0063] Figure 4E is a schematic diagram of the algorithms implemented in an RPT device according to an embodiment of the present technology.

[0064] Figure 4F is a flowchart illustrating a method performed by the therapy motor module of Figure 4E according to a form of the present technology.

[0065] Figure 4G shows a diagram of a communication system between an RPT device and a remote computing system according to an embodiment of the present technology.

[0066] Figure 4H shows exemplary operations performed by an RPT device and a remote computing system according to an embodiment of the present technology.

[0067] Figure 4I shows exemplary display screens that include demographic and / or subjective feedback requests that can be displayed for a patient according to one form of the present technology.

[0068] Figure 4J shows another example of operations performed by an RPT device and a remote computing system according to a form of the present technology.

[0069] Figure 4K shows a data flowchart in a system that provides communication between a medical device, a patient portal 8030 and a patient search service 8010 according to an embodiment of the present technology. 4.3 Humidifier

[0070] Figure 5A shows an isometric view of a humidifier according to an embodiment of the present technology.

[0071] Figure 5B shows an isometric view of a humidifier according to an embodiment of the present technology, showing a humidifier reservoir 5110 removed from the humidifier reservoir platform 5130. Petition 870260055359, dated 08 / 06 / 2026, page 28 / 176 20 / 67

[0072] Figure 5C shows a schematic of a humidifier according to an embodiment of the present technology. 5. DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

[0073] Before the present technology is described in greater detail, it should be understood that the technology is not limited to the particular examples described herein, which may vary. It should also be understood that the terminology used in this disclosure is intended to describe only the particular examples discussed herein, and is not intended to be limiting.

[0074] The following description is provided in relation to several examples that may share one or more characteristics and / or features in common. It should be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. Furthermore, any single feature or combination of features in any of the examples may constitute an additional example. 5.1 THERAPY

[0075] In one form, the present technology comprises a method for treating a respiratory disorder comprising the step of applying positive pressure to the airway entrance of a patient 1000.

[0076] In certain examples of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages through one or both nostrils.

[0077] In certain examples of the present technology, mouth breathing is limited, restricted or prevented. 5.2 TREATMENT SYSTEMS

[0078] In one form, the present technology comprises an apparatus or device for treating a respiratory disorder. The apparatus Petition 870260055359, dated 08 / 06 / 2026, page 29 / 176 21 / 67 or device may comprise an RPT 4000 device for supplying pressurized air to patient 1000 via an air circuit 4170 to a patient interface 3000. 5.3 Patient Interface

[0079] A non-invasive patient interface 3000 according to an aspect of the present technology comprises one or more of the following functional aspects: a seal-forming structure, an intake chamber, a positioning and stabilizing structure, a vent, a connection port form for connection to the air circuit 4170, and a forehead support. In some embodiments, a functional aspect may be provided by one or more physical components. In some embodiments, a physical component may provide one or more functional aspects. In use, the seal-forming structure is arranged to enclose an inlet to the patient's airways so as to facilitate the supply of positive pressure air to the airways.

[0080] If a patient interface is not capable of comfortably delivering a minimum level of positive airway pressure, a patient interface may be unsuitable for respiratory pressure therapy.

[0081] The patient interface 3000 according to an embodiment of the present technology is constructed and arranged to have the capacity to provide an air supply at a positive pressure of at least 392 Pa (4 cmH2O) relative to the environment, at least 588 Pa (6 cmH2O) relative to the environment, at least 981 Pa (10 cmH2O) relative to the environment, at least 1961 Pa (20 cmH2O) relative to the environment, at least 2942 Pa (30 cmH2O) relative to the environment, or any positive pressure between 392 Pa (4 cmH2O) and 2942 Pa (30 cmH2O) relative to the environment. 5.4 RPT DEVICE Petition 870260055359, dated 08 / 06 / 2026, page 30 / 176 22 / 67

[0082] An RPT 4000 device according to an aspect of the present technology comprises mechanical, pneumatic and / or electrical components and is configured to execute one or more 4300 algorithms, such as any of the methods, in whole or in part, described in this document. The RPT 4000 device may be configured to generate an airflow for delivery to the patient's airways, such as to treat one or more of the respiratory conditions described elsewhere in this document.

[0083] In one form, the RPT 4000 device is constructed and arranged to have the capacity to deliver an airflow in a range of -20 l / min to +150 l / min while maintaining a positive pressure of at least 588 Pa (6 cmH2O), or at least 981 Pa (10 cmH2O), or at least 1,961 Pa (20 cmH2O).

[0084] The RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panels 4015. The RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0085] The pneumatic path of the RPT device 4000 may comprise one or more air path items, for example, an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 capable of supplying air at positive pressure (for example, a blower 4142 that includes a driving machine 4144), an outlet silencer 4124 and a or more 4270 transducers, such as 4272 pressure sensors and 4274 flow rate sensors.

[0086] One or more of the air path items may be located within a removable unit structure which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form, a Petition 870260055359, dated 08 / 06 / 2026, page 31 / 176 The 23 / 67 pneumatic block 4020 is supported by, or formed as part of, the 4016 chassis.

[0087] The RPT 4000 device may have an electrical power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, transducers 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single Printed Circuit Board Assembly (PCBA) 4202. Alternatively, the RPT 4000 device may include more than one PCBA 4202.

[0088] A PTR device may comprise one or more of the following components in a single unit. Alternatively, one or more of the following components may be located as separate units. For example, the PTR device may comprise one or more of the following: air filter 4110, side panel, silencer (e.g., silencer 4120, inlet silencer 4122, outlet silencer 4124), pressure generator, pneumatic block, chassis, transducer 4270 (flow transducer, pressure transducer, motor speed transducer), light sensor, anti-reflux valve 4160, air circuit, air circuit connector, oxygen delivery port, power supply, central controller, therapy device controller, protection circuit, data connection interface, memory, output devices (e.g., display, alarms, etc...) and a user interface panel (or panels), such as those described in PCT application PCT / AU2014 / 050426 (WO2015089582), which is incorporated herein by reference.

[0089] According to one example, the user interface panel includes one or more 4220 input devices in the form of buttons, Petition 870260055359, dated 08 / 06 / 2026, page 32 / 176 24 / 67 switches or dials to allow an individual to interact with the device. The buttons, switches, or dials may be physical devices, or software devices accessible via a touchscreen. The buttons, switches, or dials may, in one form, be physically connected to the external housing 4010, or may, in another form, be in wireless communication with a receiver that is electrically connected to the central controller 4230.

[0090] In one form, the 4220 input device can be constructed and arranged to allow an individual to select a value and / or a menu option. 5.4.1.1 DATA COMMUNICATION SYSTEMS

[0091] In one embodiment of the present technology, a data communication interface 4280 is provided, and is connected to the central controller 4230. The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0092] In one form, the 4280 data communication interface is part of the 4230 central controller. In another form, the 4280 data communication interface is separate from the 4230 central controller, and may comprise an integrated circuit or a processor.

[0093] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can use wired communication (e.g., via Ethernet or fiber optics) or a wireless protocol (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0094] In one form, local external communication network 4284 Petition 870260055359, dated 08 / 06 / 2026, page 33 / 176 25 / 67 uses one or more communication standards, such as Bluetooth or a consumer infrared protocol.

[0095] In one form, a 4286 remote external device is one or more computers, for example, a networked group of computers. In another form, a 4286 remote external device may be virtual computers, rather than physical computers. In any case, such a 4286 remote external device may be accessible to an appropriately authorized individual such as a clinician.

[0096] The local external device 4288 can be a personal computer, mobile phone, tablet computer, or remote control. 5.4.1.2 OUTPUT DEVICES INCLUDING OPTIONAL DISPLAY, ALARMS

[0097] An output device 4290 according to the present technology may take the form of one or more of a visual, audio and haptic unit. A visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display. 5.4.1.2.1 DISPLAY ACTUATOR

[0098] A display actuator 4292 receives as input the characters, symbols or images intended for display on the display 4294, and converts them into commands that cause the display 4294 to display those characters, symbols or images. 5.4.1.2.2 DISPLAY

[0099] A 4294 display is configured to visually display characters, symbols, or images in response to commands received from the 4292 display driver. For example, the 4294 display may be an eight-segment display; in that case, the 4292 display driver converts each character or symbol, as in Figure 0, into eight logic signals that indicate whether the respective eight segments should be activated to display a particular character or symbol. 5.4.2 RPT DEVICE ALGORITHMS Petition 870260055359, dated 08 / 06 / 2026, page 34 / 176 26 / 67

[00100] As mentioned above, in some forms of the present technology, the central controller 4230 can be configured to deploy one or more algorithms 4300 expressed as computer programs stored on a non-transient, computer-readable storage medium, such as memory 4260. The algorithms 4300 are generally grouped into groups called modules. The modules may include a preprocessing module 4310 that provides pressure compensation 4312, ventilation flow rate estimation 4314, leak flow rate estimation 4316, and respiratory flow rate estimation 4318. The processing from the preprocessing module 4310 can be used as an input in a therapy motor module 4320.The therapy motor module 4320 comprises 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 obstruction determination 4327, target ventilation determination 4328, and therapy parameter determination 4329. A therapy control module 4330 receives therapy parameter inputs from the therapy parameter determination algorithm 4329 of the therapy motor module 4320 and controls the pressure generator 4140 to deliver an airflow according to the therapy parameters. In one embodiment of the present technology, the central controller 4230 executes one or more methods 4340 for fault condition detection.Details relating to one or more operations performed by algorithms are described in PCT application PCT / AU2014 / 050426 (WO2015089582), which is incorporated herein by reference. 5.5 AIR CIRCUIT

[00101] An air circuit 4170 according to an aspect of Petition 870260055359, dated 08 / 06 / 2026, p. 35 / 176 27 / 67 present technology is a conduit or tube constructed and arranged to allow, in use, an airflow to move between two components, such as an RPT 4000 device and a patient interface 3000.

[00102] In particular, the air circuit 4170 may be in fluid connection with the outlet of the pneumatic block 4020 and a patient interface. The air circuit may be referred to as the air delivery tube. In some cases, there may be separate members of the circuit for inhalation and exhalation. In other cases, a single member is used.

[00103] In some embodiments, the air circuit 4170 may comprise one or more heating elements configured to heat the air in the air circuit, for example, to maintain or raise the air temperature. The heating element may be in the form of a heated wire circuit, and may comprise one or more transducers, such as temperature sensors. In one embodiment, the heated wire circuit may be helically wrapped around the geometric axis of the air circuit 4170. The heating element may be in communication with a controller, such as a central controller 4230. An example of an air circuit 4170 comprising a heated wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein in its entirety by reference. 5.6 Two-Way Communication for Therapy and / or Personalized Training

[00104] In one embodiment of the present technology, a medical device (e.g., an RPT device) may include bidirectional communication with one or more remote processing systems to facilitate individualized training programs, personalized therapy, and / or targeted care. The medical device may be configured to capture data and / or transmit the data to the remote processing system for processing. The data Petition 870260055359, dated 08 / 06 / 2026, page 36 / 176 28 / 67 captured data may include sensor data, demographic feedback, and / or subjective feedback. The remote processing system can perform patient segmentation and / or advanced analytics using the received data and provide the medical device with individualized solutions. Individualized solutions may include personalized training programs for increased engagement and motivation, personalized therapy with automated comfort and / or therapy configuration updates to increase long-term adherence and / or targeted care and follow-up based on knowledge of which patients need help. Patient segmentation and advanced analytics may include performing deep machine learning using data from other users and using one or more trained models to provide the individualized solutions.

[00105] Unlike conventional systems in which settings for a medical device have to be pre-loaded and modified by a highly trained technician, examples of the present technology provide the medical device to be configured automatically after the device is put into use. The settings for the medical device and recommendations for the patient can be determined remotely and quickly without requiring a clinician to perform multiple interactions to modify device settings before a patient feels comfortable using the medical device. Furthermore, the feedback received from the user and the medical device settings can be used to improve settings on other medical devices and provide relevant recommendations for other patients.

[00106] Figure 4G shows a diagram of a communication system between an RPT 4000 device and a system of Petition 870260055359, dated 08 / 06 / 2026, p. 37 / 176 29 / 67 remote computing. Figure 4G includes one or more RPT 4000 devices associated with a patient 1000. The present technology is not limited to one RPT device, but can be applied to other medical devices. The RPT 4000 device can be configured to communicate via a data communication interface 4280 with a remote external device 4286 and / or local external devices 4288 (e.g., a personal computer, mobile phone, tablet computer and / or remote control) and / or remote external device. The local external devices 4288 can be configured to communicate directly with the RPT 4000 device when located in close proximity to the RPT 4000 device or remotely via a local or external network when the local external device 4288 is not located near the RPT 4000 device.The remote external device 4286 can be accessed by an appropriately authorized individual, such as a clinician, manufacturer, and / or supplier of the device. As shown in Figure 4G, the RPT 4000 device can also communicate with a remote computing system that includes a server 6030 and / or a cloud computing platform 6040 (e.g., Amazon Web Services™, Google™ Cloud Platform, Microsoft™ Azure).

[00107] One or more other medical devices 6062 or 6064 (which may be RPT devices), associated with other patients 1002 and 1004, may be configured to communicate with the remote external device 4286, the server 6030 and / or the cloud computing platform 6040.

[00108] The devices illustrated in Figure 4G can communicate via a communication link 6020 comprising a remote external communication network 4282 and / or a local external communication network 4284.

[00109] The RPT 4000 device and / or medical devices 6062 and Petition 870260055359, dated 08 / 06 / 2026, page 38 / 176 30 / 67 6064 can be configured to transmit, via communication link 6020, sensor data, demographic feedback, and / or subjective feedback to server 6030 and / or cloud computing platform 6040. Server 6030 and / or cloud computing platform 6040 can be configured to perform patient segmentation and / or advanced analytics using the received data and provide individualized solutions to RPT devices. Individualized solutions may include individualized training programs, personalized therapy, and / or targeted care.

[00110] Figure 4H shows exemplary operations performed by an RPT 4000 device and a remote computing system according to an embodiment of the present technology. Although Figure 4 shows the operations performed by specific devices, the operations shown are not so limited. One or more operations may be performed by other devices operationally coupled to the RPT 4000 device and / or remote computing system. In some examples, one or more operations shown as being performed by the RPT 4000 device may be performed using a web or mobile application running on another device (e.g., a local external device 4288).

[00111] The RPT 4000 device can be configured to perform RPT 4000 device setup (step 7010). Setup may include associating a patient with the RPT 4000 device, configuring initial RPT 4000 device settings for the patient, and / or providing instructions on how to use the device. One or more operations disclosed in Provisional Application No. U.S. 62 / 749,430, filed October 23, 2018, entitled SYSTEMS AND METHODS FOR SETUP OF CPAP SYSTEMS, and Application No. U.S. 16 / 661,250, filed October 23, 2019, Petition 870260055359, dated 08 / 06 / 2026, page 39 / 176 31 / 67 entitled SYSTEMS AND METHODS FOR SETUP OF CPAP SYSTEMS, each of which is incorporated herein by reference in its entirety, can be performed during the setup of the RPT 4000 device.

[00112] Configuration can be performed when the RPT 4000 device is powered on for the first time after being purchased or reset, or when the RPT 4000 device is assigned to a new patient. Configuration can be performed without user interaction by applying settings to the RPT 4000 device stored in memory (e.g., memory 4260 or memory external to the RPT 4000 device) or by receiving instructions from a remote external device 5286 controlled by a clinician, manufacturer, and / or distributor of the device.

[00113] Patient input can be requested and received during the configuration of the RPT 4000 device and / or other devices. In some examples, instructions and / or questions can be provided using the 4290 output devices, and patient input can be received using the 4220 input devices. In other examples, only the RPT 4000 device can be used to receive input during configuration. In other examples, a local external device 4288 can be used, instead of or in addition to the RPT 4000 device, to receive user input for configuring the RPT 4000 device. Display screens can be generated on the RPT 4000 device and / or the external device for requesting patient input during device configuration. In some examples, audio instructions and / or sound responses can be received by the RPT 4000 device and / or the local external device 4288.In some examples, data entry by a user and / or individualized training programs, personalized therapy and / or targeted care and follow-up (by. Petition 870260055359, dated 08 / 06 / 2026, page 40 / 176 32 / 67 example, provided in response to input data) can be provided through a range of different mechanisms (e.g., applications, web, email, telephone, etc.).

[00114] The RPT 4000 device can be operated (step 7012) based on the device configuration performed during setup. During operation of the RPT 4000 device, the device operation can 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.

[00115] After one or more predetermined conditions are met, feedback requests may be displayed to the patient (step 7018). The feedback request may be displayed on the display 4294 or on the device and / or local external device 4288 (e.g., in an application). The feedback request may request subjective and demographic feedback from the user in the form of a question or instruction. The feedback request may be performed automatically when the predetermined condition is met. Feedback is not limited to subjective and demographic feedback and may include additional questions.Feedback, demographic and / or subjective feedback may include sleep study results, symptoms, comorbidities, or other health information, including the presence of other sleep issues (e.g., insomnia), level of knowledge about sleep apnea, level of comfort with upcoming therapy, stage in the journey (new to therapy or experienced user), and / or motivation.

[00116] The predetermined condition may include a predetermined amount of time elapsed after the RPT 4000 device is configured, the patient seeking a specific goal with the Petition 870260055359, dated 08 / 06 / 2026, page 41 / 176 33 / 67 Use of the device for a predetermined period of time (e.g., a pre-configured number of hours, days, or weeks), using a specific feature offered by the RPT 4000 device (e.g., operating the device in a low-power mode), a predetermined number of times or for a predetermined period of time, completing the configuration of the RPT 4000 device, receiving a signal from the remote computing system or device operated by a clinician, receiving feedback requests from another device, having a set of flags indicating that feedback requests are available for display to the patient, and / or receiving a notification that the feedback request is available for download.

[00117] In response to the feedback request, inputs may be received representing the patient's demographic and / or subjective feedback (step 7020). Inputs may be received using only the RPT 4000 device (e.g., via input devices 4220), only the external local device 4288, or both the RPT 4000 device and the external local device 4288.

[00118] Figure 4I shows exemplary display screens that include demographic and / or subjective feedback requests that can be displayed for a patient. Feedback requests can be displayed on a 4294 display of the 4000 RPT device and / or display associated with the local external device 4288. Although Figure 4I shows the display screens in a specific order, deployment is not so limited. One or more of the display screens can be provided in a different order or not included in the sequence. One or more other display screens can also be included in the sequence. Petition 870260055359, dated 08 / 06 / 2026, page 42 / 176 34 / 67

[00119] Introduction screens 7050 and 7052 may include introductory text, graphics, and / or a video with information that introduces the patient to the system's customization features, components, and / or therapy. Introduction screen 7050 may be displayed for a predetermined period of time before automatically transitioning to display screen 7052. Display screen 7052 may provide selectable options for the user to continue responding to the displayed feedback request or skip the RPT 4000 device customization feature. In some instances, instead of or in addition to skipping the customization feature, the user may be provided with an option to provide the information later. Introduction screens 7050 and / or 7052 may be displayed only when the unit is first powered on by a user (e.g., after purchasing the unit or after restarting) or a predetermined number of times until the personalized information is received.

[00120] Display screen 7054 shows an option for the patient to select their gender. As shown on display screen 7054, the patient may be offered a selectable option to skip the feedback prompt. One or more of the other feedback prompts may also include an option to skip a response prompt.

[00121] Display screen 7056 shows an option to enter a patient's age. In other examples, the feedback request may include entering the day, month, and / or year of the patient's birthday.

[00122] Display screen 7058 shows an option to enter a patient's height and display screen 7060 shows an option to enter a patient's weight.

[00123] Display screen 7062 shows a question asking if the patient has used the RPT 4000 device previously. In some Petition 870260055359, dated 08 / 06 / 2026, page 43 / 176 35 / 67 examples, the question may include providing several other RPT devices the patient has used, or the level of experience patients feel they have on a predetermined scale when using the RPT 4000 device.

[00124] Display screen 7064 shows a question for the patient to rate how sleepy they generally feel during the day. The user may be provided with a scale ranging from not being sleepy to being very sleepy. Other subjective sleep feedback questions may include sleep regularity, sleep satisfaction, sleep alertness, sleep timing, sleep effectiveness, and / or sleep duration. Questions may include: do you generally wake up within the same time (within 1 hour) every day, how satisfied are you with your sleep in general, how well are you able to stay awake all day without falling asleep or dozing off, the period from 2 am to 4 am is generally in the middle of your nighttime sleep, are you generally awake for less than 39 minutes during the night, and / or do you generally sleep between 6 and 8 hours per day.One or more of the answers to the questions may have a sliding scale and / or multiple selectable responses (e.g., rarely, sometimes, and generally).

[00125] In one example of the present technology, feedback may include non-subjective feedback. Feedback may include an apnea-hypopnea index entered by the patient and / or retrieved from a database or a physician or clinician.

[00126] Based on the feedback results, the patient can be assigned a sleep classification, training programs, and / or personalized patient therapy. This information can be determined by the RPT 4000 device and / or other devices (e.g., devices shown in Figure 4G). The sleep classification can be displayed to the patient and / or updated. Petition 870260055359, dated 08 / 06 / 2026, page 44 / 176 36 / 67 as additional feedback is received periodically from the patient.

[00127] Other display screens may include other feedback requests such as level of how well the patient slept at night, mask comfort level, breathing comfort while using CPAP, and / or level of satisfaction with the operation of the device. In some examples, subjective questions (e.g., sleep comfort) may be received a plurality of times, each for a different time period. For example, the RPT 4000 device may be configured to prompt a patient to provide feedback on sleep comfort for a predetermined number of days (e.g., seven days).

[00128] Display screens that request feedback may include an option to select that the answer is now known and / or provide an option to retrieve the information from an external source (e.g., a database, physician records, external device, etc.).

[00129] In some examples, a single feedback request may be displayed on the screen, or two or more feedback requests may be displayed simultaneously on a single screen. For example, the request to enter the patient's age and height may be displayed simultaneously on one screen.

[00130] In one embodiment of the present technology, display screens with feedback prompts may be displayed on a touch-sensitive input display. In one embodiment of the present technology, inputs to the questions displayed on the screen may be entered using one or more 4220 input devices that include physical buttons, switches or dials, or software devices accessible via the touch screen.

[00131] In one form of the present technology, requests for Petition 870260055359, dated 08 / 06 / 2026, page 45 / 176 37 / 67 feedback can be delivered audibly to the patient using loudspeakers and / or verbal feedback responses can be captured using a microphone.

[00132] After responses to feedback requests are received, the responses can be stored in memory and / or transmitted (step 7022) to the remote computing system. In one embodiment of the present technology, the data can be transmitted directly to an on-demand cloud computing platform (e.g., Amazon Web Services™, Google™ Cloud Platform, Microsoft™ Azure). Responses may include demographic and / or subjective feedback data. In one embodiment of the present technology, if a connection to the remote computing system is unavailable, the feedback data can be stored in memory 4260 until the connection becomes available.

[00133] In step 7022, other data can be transmitted with the feedback data to the remote computing system.For example, other data may include therapy data to determine if the patient has used the RPT device in accordance with the compliance rule, RPT 4000 device identification information (e.g., serial number), RPT 4000 device location information, user profile data, data captured by sensors (e.g., transducer 4270), settings applied during RPT 4000 device setup, type of accessories attached to the RPT 4000 device, and / or modifications made to settings by the patient and / or when such modifications were made.

[00134] The remote computing system receives data (step 7024), analyzes the data (step 7026), and transmits analysis results (step 7028) to the RPT 4000 device and / or web or mobile application. The remote computing system can receive the Petition 870260055359, dated 08 / 06 / 2026, page 46 / 176 38 / 67 demographic and / or subjective feedback, and other data from the RPT 4000 device or local external device. The data can be directly received by the remote computing system for processing. The remote computing system may include a 6030 server and / or a 6040 cloud computing platform. The 6030 server may be a non-cloud-based server managed by the manufacturer or clinician.

[00135] The remote computing system can segment patient data (e.g., age range, gender, weight, environment, etc.) and use models developed using similar and / or different data from other users to determine what the patient needs and / or what settings on the RPT 4000 device should be modified.

[00136] Models can be predetermined 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 subjective and demographic feedback received from other patients 1002 and / or 1004. Advanced analytics, artificial intelligence, and / or machine learning can be performed on data from a large number of patients, and models can be updated with new data once new data (e.g., data including demographic feedback, subjective feedback, and / or changes to compliance standards) become available. Analysis results may include individualized training programs, personalized therapy, and / or targeted care and follow-up.

[00137] In response to the transmission of feedback data, the RPT 4000 device can receive analysis results (step Petition 870260055359, dated 08 / 06 / 2026, page 47 / 176 39 / 67 7030) of the remote computing system. Analysis results may include individualized training programs, personalized therapy and / or targeted care and follow-up.

[00138] Individualized training programs can be provided to increase patient engagement and motivation. Individualized training programs may include instructions on how to properly use the device, explain the benefits of using features provided by the device, and / or suggest other medical devices and / or accessories that may be beneficial to the patient. For example, information about an accessory (e.g., a different type of mask) that will enhance the patient's experience using the RPT 4000 device may be displayed on the display 4294 or the external device location 4288.

[00139] Personalized therapy can provide automated comfort settings that have been shown to increase long-term adherence (LTA). Personalized therapy can be automatically applied to the RPT 4000 device without patient interaction. In some examples, the patient may be provided with information about the therapy changes and may be asked to accept the proposed changes before they are applied.

[00140] Targeted care and follow-up may include notifying the patient that they need to make changes to their care or need to schedule an appointment with a clinician or other specialist. In some examples, the RPT 4000 device and / or the external local device 4288 can be used to schedule and / or conduct an appointment with a clinician or other specialist.

[00141] The analysis results can be used to adjust settings (step 7032) of the RPT 4000 device. Modifying the settings may include adjusting one or more comfort settings of the RPT 4000 device. For example, the analysis results may include instructions for modifying settings of Petition 870260055359, dated 08 / 06 / 2026, page 48 / 176 40 / 67 ramp pressure, expiratory relief settings, humidity settings, and air temperature settings. In one form of the present technology, analysis results may indicate that continued use of the RPT 4000 device is unsafe and the use of the RPT 4000 device may be disabled.

[00142] After the analysis results are applied, the operation of the RPT 4000 device can be continued (step 7034). Applying the analysis results and operating the RPT 4000 device using the updated settings will control the RPT 4000 device more effectively to meet patient needs. In some instances, modifications can be made to operate the device more efficiently (e.g., using less power or a lower temperature of heated delivery air) without significantly sacrificing patient comfort.

[00143] After a predetermined time, one or more of the previously made feedback requests and / or new feedback requests may be presented to the patient and responses received (step 7036). The response can be used to determine if the previously applied settings were effective and / or if additional changes to the operation and / or use of the RPT 4000 device need to be made. Additional feedback requests may be made periodically or when new feedback requests become available through the remote computing system.

[00144] In some examples, the additional feedback request may be displayed every time the user turns on the RPT 4000 device. When the RPT 400 device is used, a sleep classification, a daily perception (e.g., daily recommendation) may be displayed to the patient. Petition 870260055359, dated 08 / 06 / 2026, page 49 / 176 41 / 67 individualized based on feedback from patients and / or another patient). Providing additional feedback may include the user updating one or more of the previously provided feedback (e.g., age, height, weight, and / or sleep feedback).

[00145] In one embodiment of the present technology, some feedback requests may be submitted on the RPT 4000 devices and other feedback requests may be submitted on the local external device 4288 or another medical device associated with the same patient 1000. Feedback requests that are submitted on one device may be marked as displayed and not requested on other devices.

[00146] In one embodiment of the present technology, operations relating to displaying feedback requests and receiving inputs for feedback requests can be performed during device configuration (step 7010).

[00147] Figure 4J shows another example of operations performed by an RPT 4000 device and a remote computing system. In the example illustrated in Figure 4H, the feedback data request was pre-stored in the RPT 4000 device. For example, the feedback data request may have been pre-stored in memory by the manufacturer, distributor, or clinician. In the example illustrated in Figure 4J, the remote computing system transmits the feedback data request (step 7016). The RPT 4000 device receives the transmitted feedback request data (step 7014) from the remote computing system and uses the data to receive patient feedback. In some examples, the system that transmits the feedback data request may be a different system from the system that performs the analysis using the demographic and / or subjective feedback data transmitted from the RPT 4000 device. Petition 870260055359, dated 08 / 06 / 2026, page 50 / 176 42 / 67

[00148] The remote computing system can transmit the feedback data request in response to a request form from the RPT 4000 device. In some instances, the remote computing system can promote the feedback data request to the RPT 4000 device at the same predetermined time interval, or ad hoc (either directly or through the home medical equipment).

[00149] The feedback data request can be entered by a physician or clinician. The physician or clinician may be provided with a user interface to enter their own questions as part of the feedback data request. The physician or clinician may be provided with a feature to ask their own patient questions via the RPT 4000 device or a device associated with the RPT 4000 device (e.g., the local external device 4288). For example, the physician or clinician may enter the questions using the remote computing system. The physician or clinician may associate one or more of the questions with one or more conditions to distribute the questions to the RPT 4000 device. The conditions may include one or more patient characteristics, device type, peripheral devices (e.g., mask type, tube, etc.) connected to the RPT 4000 device, and / or device operating parameters.

[00150] Figure 4K shows a data flowchart in a system that provides communication between a medical device (e.g., RPT 4000 device), a patient portal 8030, and a patient search service 8010.

[00151] The 8010 patient survey service can be deployed on one or more servers, which may include cloud and / or dedicated servers (e.g., 6030 server). The 8010 patient survey service can coordinate the management and communication of questions and answers for subjective and demographic feedback. Petition 870260055359, dated 08 / 06 / 2026, page 51 / 176 43 / 67 As shown in Figure 4K, the 8010 patient survey service can support sending queries to a patient account associated with a medical device. The patient account can be accessed via a web application or mobile application running on a local 4288 device or via the RPT 4000 device. The patient account accessed via the web or mobile application can provide medical device monitoring, reporting and / or configuration, and patient training.

[00152] The 8020 patient survey service can notify clients of questions that are available. Questions can be made available when they are added (e.g., through advertising) to a content management system. Questions can be retrieved from the 8020 patient survey service via GET calls. In one example, a patient account accessed through the web or mobile application can call the database and obtain questions via proxy through the 8030 patient portal. Questions can be provided in JavaScript Object Notation (JSON) format, which represents the content of the questions and possible answers. The presentation of the questions can be embedded in the application as HTML content.The patient account accessed via the web or mobile application can send responses back to the 8020 patient survey service via proxy through the 8030 patient portal (e.g., via a POST instruction).

[00153] The medical device can call base and obtain queries via proxy through the 8024 MCS device and send a response back to the 8020 patient lookup service via proxy through the 8024 MCS device (e.g., via a POST instruction). GET calls can include a serial number from the medical device to the 8010 patient lookup service. Petition 870260055359, dated 08 / 06 / 2026, page 52 / 176 44 / 67 Keep records of which questions were sent to which device and / or application.

[00154] In one aspect, the 8010 patient survey service can manage questions so that questions are made available to the patient portal after a predetermined period of time (e.g., 48 hours). This can minimize questions being asked twice.

[00155] According to another aspect, the 8010 patient survey service can manage questions so that questions already answered by a patient are not shown again. In one example, the 8010 patient survey service can keep records of answered questions on a platform (e.g., a medical device) and not display those questions in a patient account accessed through a web or mobile application.

[00156] Responses to questions can be received by the patient survey service 8010 from the medical device or the patient's account accessed via the web or mobile application. Responses can be transmitted to a cloud computing platform 6040 for advanced analytics. The cloud computing platform may include an analytical data lake with data from a large number of other patients. Deep neural networks can be used to build models and analyze the received responses. In some examples, the patient survey service 8010 may place the received responses in a queue for advanced analytical consumption.

[00157] The 8010 patient research service can support providing the questions and / or answers for a remote patient monitoring system. Remote monitoring can be provided through a web or mobile application that runs on a remote external device 4286. Remote monitoring can Petition 870260055359, dated 08 / 06 / 2026, page 53 / 176 45 / 67 provide a secure, cloud-based patient management system for online patient monitoring, enabling clinicians to quickly access patient data, share clinical insights with other healthcare professionals, and reduce patient follow-up costs. Remote monitoring can receive medical device operating information, compliance information, device configuration, changes made to device settings, questions presented to the patient, and / or answers received from the patient. The clinician can use the data provided by remote monitoring to further suggest changes to the patient's training programs and / or personalized therapy.

[00158] The 8010 patient survey service can support receiving initial questions embedded in the medical device code. During manufacturing, initial questions can be loaded into the medical device.The medical device may present initial questions and receive answers to those questions during 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 following setup). The initial questions may be transmitted by the medical device to the 8010 patient survey service for distribution to remote monitoring and / or the web or mobile application. In some instances, the initial questions may be made available via the web or mobile application if the initial questions have not been answered on the medical device. The 8010 patient survey service may maintain records of which initial questions were answered.

[00159] In some examples, the initial questions stored in the medical device may be provided separately to the patient research service 8010 by the manufacturer. In this example, the patient research service 8010 may receive device identification. Petition 870260055359, dated 08 / 06 / 2026, page 54 / 176 46 / 67 physician (e.g., serial number) and the initial questions that were 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.

[00160] The 8030 patient portal can receive training content to provide the patient with instructions on how to use the device, how to improve device use, and / or obtain better device outcomes. The training service can provide training content based on results from analysis of the patient's demographic and / or subjective feedback. 5.6.1 Oxygen Delivery

[00161] In one embodiment of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block 4020, to the air circuit 4170 and / or to a patient interface 3000. 5.7 HUMIDIFIER

[00162] In one embodiment of the present technology, a humidifier 5000 (for example, as shown in Figure 5A) is provided to alter the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and raise the temperature of the airflow (relative to ambient air) before delivery to the patient's airways.

[00163] The humidifier 5000 may comprise 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, as shown in Figure 5A and Figure 5B, an inlet and an outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may Petition 870260055359, dated 08 / 06 / 2026, page 55 / 176 47 / 67 further comprises a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and comprises a heating element 5240.

[00164] According to one arrangement, the reservoir 5110 comprises a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume in the reservoir 5110, a humidifier reservoir platform 5130 (as shown in Figure 5B) configured to receive the humidifier reservoir 5110 with a locking lever 5135 configured to retain the reservoir 5110 and / or a water level indicator 5150 (as shown in Figure 5A-5B), and / or one or more humidifier transducers (sensors) 5210 instead of, or in addition to, transducers 4270 described above. Humidifier transducers 5210 may include one or more of an air pressure sensor 5212, an airflow rate transducer 5214, a temperature sensor 5216, or a humidity sensor 5218, as shown in Figure 5C.A humidifier transducer 5210 can produce one or more output signals that can be communicated to a controller, such as the central controller 4230 and / or the humidifier controller 5250. In some forms, a humidifier transducer may be located externally to the humidifier 5000 (as in the air circuit 4170) while communicating the output signal to the controller.

[00165] According to an arrangement of the present technology, a humidifier 5000 may comprise a humidifier controller 5250, as shown in Figure 5C. In one embodiment, the humidifier controller 5250 may be a part of the central controller 4230. In another embodiment, the humidifier controller 5250 may be a separate controller, which may be in communication with the central controller 4230. Petition 870260055359, dated 08 / 06 / 2026, p. 56 / 176 48 / 67

[00166] In one form, the 5250 humidifier controller can receive input measurements of properties (such as temperature, humidity, pressure, and / or flow rate), for example, of airflow, water in the 5110 reservoir, and / or in the 5000 humidifier. The 5250 humidifier controller can also be configured to execute or deploy humidifier algorithms and / or deliver one or more output signals.

[00167] As shown in Figure 5C, the humidifier controller 5250 may comprise one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of a heated air circuit 4171 and / or a heating element controller 5252 configured to control the temperature of a heating element 5240.

[00168] Examples of humidifier components are described in PCT application PCT / AU2014 / 050426 (WO2015089582), which is incorporated herein by reference. 5.8 Modes of Respiratory Pressure Therapy

[00169] Various modes of respiratory pressure therapy can be implemented by the RPT 4000 device depending on the values ​​of parameters A and P0 in the treatment pressure equation (1) used by the therapy parameter determination algorithm 4329 and a form of the present technology. 5.8.1 CPAP Therapy

[00170] In some implementations of this form of the present technology, the amplitude A is identically zero, therefore, the treatment pressure Pt is identically equal to the baseline pressure P0 throughout the respiratory cycle. Such implementations are generally grouped under the heading of CPAP therapy. In such implementations, it is not necessary for the therapy motor module 4320 to determine phase Φ or the pattern. Petition 870260055359, dated 08 / 06 / 2026, p. 57 / 176 49 / 67 of waveform Π(Φ). In step 4560, the central controller 4230 reduces the base pressure P0 by a decrement, provided that the reduced base pressure P0 does not fall below a minimum treatment pressure Pmin. Method 4500 then returns to step 4520. In one deployment, the decrement is proportional to the value of P0-Pmin, so that the reduction in P0 to the minimum treatment pressure Pmin in the absence of any detected events is exponential. In one deployment, the proportionality constant is adjusted so that the time constant τ of the exponential reduction of P0 is 60 minutes and the minimum treatment pressure Pmin is 392 Pa (4 cmH2O). In other deployments, the time constant τ could be as low as 1 minute and as high as 300 minutes, or as low as 5 minutes and as high as 180 minutes.In other deployments, the minimum treatment pressure Pmin can be as low as 0 Pa (0 cmH2O) and as high as 784 Pa (8 cmH2O), or as low as 196 Pa (2 cmH2O) and as high as 588 Pa (6 cmH2O). Alternatively, the decrease in P0 could be predetermined, so the reduction in P0 for the minimum treatment pressure Pmin in the absence of any detected events is linear. 5.8.2 Two-Level Therapy

[00171] In other deployments of this form of the present technology, the amplitude value A in equation (1) may be positive. Such deployments are known as two-level therapy, because the treatment pressure Pt is determined using equation (1) with a positive amplitude A, the therapy parameter determination algorithm 4329 oscillates the treatment pressure Pt between two values ​​or levels in synchrony with the patient's spontaneous respiratory effort 1000. That is, based on the typical waveform patterns Π(Φ t) described above, the therapy parameter determination algorithm 4329 increases the treatment pressure Pt to P0 + A (known as Petition 870260055359, dated 08 / 06 / 2026, page 58 / 176 50 / 67 (IPAP) at the beginning of, or during, inspiration and reduces the treatment pressure Pt to the baseline pressure P0 (known as EPAP) at the beginning of, or during, expiration.

[00172] In some forms of bilevel therapy, IPAP is a treatment pressure that serves the same purpose as the treatment pressure in CPAP therapy modes, and EPAP is IPAP minus amplitude A, which has a small value (some Pa (cmH2O)), sometimes referred to as Expiratory Pressure Relief (EPR). Such forms are sometimes referred to as CPAP therapy with EPR, which is generally considered to be more comfortable than direct CPAP therapy. In CPAP therapy with EPR, either IPAP or EPAP can be constant values ​​that are embedded in code or manually entered into the RPT 4000 device. Alternatively, the therapy parameter determination algorithm 4329 can repeatedly compute IPAP and / or EPAP during CPAP with EPR.In this alternative, the therapy parameter determination algorithm 4329 repeatedly computes EPAP and / or IPAP as a function of sleep-disordered breathing indices or measures returned by the respective algorithms in the therapy engine module 4320, in a manner analogous to the computation of baseline pressure P0 in APAP therapy described above.

[00173] In other forms of bilevel therapy, the amplitude A is large enough that the RPT 4000 device performs some or all of the patient's breathing work 1000. In such forms, known as pressure support ventilation therapy, the amplitude A is termed the pressure support, or swing. In pressure support ventilation therapy, IPAP is the baseline pressure P0 plus the pressure support A, and EPAP is the baseline pressure P0.

[00174] In some forms of pressure support ventilation therapy, known as pressure support ventilation therapy Petition 870260055359, dated 08 / 06 / 2026, page 59 / 176 51 / 67 fixed, the pressure support A is fixed at a predetermined value, for example, 981 Pa (10 cmH2O). The predetermined pressure support value is a setting of the RPT 4000 device, and can be adjusted, for example, by being embedded in code during the configuration of the RPT 4000 device or by manual input via the 4220 input device.

[00175] In other forms of pressure support ventilation therapy, widely known as servo-ventilation, the therapy parameter determination algorithm 4329 takes as input some currently measured or estimated respiratory cycle parameter (e.g., the current Vent measurement) and a target value of that respiratory parameter (e.g., a target value Vtgt) and repeatedly adjusts the parameters of equation (1) to bring the current respiratory parameter measurement toward the target value. In a form of servo-ventilation known as adaptive servo-ventilation (ASV), which has been used to treat CSR, the respiratory parameter is ventilation, and the target ventilation value Vtgt is computed by the target ventilation determination algorithm 4328 from the typical recent ventilation Vtyp, as described above.

[00176] In some forms of servo-ventilation, the therapy parameter determination algorithm 4329 applies a control methodology to repeatedly compute pressure support A in order to bring the current respiratory parameter measurement toward the target value. This control methodology is Proportional-Integral (PI) control. In a PI control implementation, suitable for ASV modes in which a target ventilation Vtgt is set to slightly less than the typical recent ventilation Vtyp, pressure support A is repeatedly computed as: A = G í (Vent - Vtgt)dt (2)

[00177] where G is the PI control gain. Larger values ​​of Petition 870260055359, dated 08 / 06 / 2026, page 60 / 176 52 / 67 G gain can result in positive feedback in the 4320 therapy motor module. Lower G gain values ​​may allow some residual untreated CSR or central sleep apnea. In some implantations, the G gain is fixed at a predetermined value, such as -39 Pa (0.4 cmH2O) / (l / min) / s. Alternatively, the G gain can be varied between therapy sessions, starting small and increasing from session to session until a value that substantially eliminates CSR is achieved. Conventional means of retrospectively analyzing the parameters of a therapy session to assess the severity of CSR during the therapy session can be used in such implantations. In still other implantations, the G gain can vary depending on the difference between the current Vent measurement and the target Vent Vtgt.

[00178] Other servo-ventilation control methodologies that can be applied by the therapy parameter determination algorithm 4329 include proportional (P), proportional-differential (PD), and proportional-integral-differential (PID).

[00179] The pressure support value A computed by the equation can be clipped to a range defined as [Amin, Amax]. In this deployment, pressure support A is established by the absence of minimum pressure support Amin until the current ventilation measurement Vent falls below the target ventilation Vtgt, at which point A begins to increase, only falling back to Amin when Vent exceeds Vtgt once again.

[00180] The Amin and Amax pressure support limits are RPT 4000 device settings, adjusted, for example, by being embedded in code during the RPT 4000 device configuration or by manual input via the 4220 input device.

[00181] In pressure support ventilation therapy modes, Petition 870260055359, dated 08 / 06 / 2026, page 61 / 176 53 / 67 EPAP is the baseline pressure P0. As with baseline pressure P0 in CPAP therapy, EPAP can be a constant value that is prescribed or determined during titration. Such a constant EPAP can be adjusted, for example, by being embedded in code during the RPT 4000 device setup or by manual input via the 4220 input device. This alternative is sometimes referred to as fixed EPAP pressure support ventilation therapy. EPAP titration for a given patient can be performed by a clinician during a titration session with the aid of PSG, with the aim of preventing obstructive apneas, thus maintaining an open airway for pressure support ventilation therapy, similarly to baseline pressure P0 titration in constant CPAP therapy.

[00182] Alternatively, the 4329 therapy parameter determination algorithm can repeatedly compute the baseline pressure P0 during pressure support ventilation therapy. In such deployments, the 4329 therapy parameter determination algorithm repeatedly computes EPAP as a function of sleep-disordered breathing indices or measures returned by the respective algorithms in the 4320 therapy engine module, such as one or more of flow limitation, apnea, hypopnea, airway clearance, and snoring. Because the continuous computation of EPAP resembles the manual adjustment of EPAP by a clinician during EPAP titration, this process is also sometimes referred to as EPAP auto-titration, and the therapy mode is known as auto-titration EPAP pressure support ventilation therapy or auto-EPAP pressure support ventilation therapy. 5.9 Glossary

[00183] For the purposes of this technology disclosure, in certain forms of this technology, one or more of the following definitions may apply. In other forms of this technology Petition 870260055359, dated 08 / 06 / 2026, page 62 / 176 54 / 67 technology, alternative definitions may apply. 5.9.1 GENERAL

[00184] Air. In certain forms of the present technology, air may be understood to mean atmospheric air and, in other forms of the present technology, air may be understood to mean some other combination of respirable gases, for example, atmospheric air enriched with oxygen.

[00185] Environment: In certain forms of the present technology, the term environment will be understood to mean (i) external to the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[00186] For example, ambient humidity in relation to a humidifier might be the humidity of the air immediately surrounding the humidifier, for example, the humidity in the room where a patient is sleeping. Such ambient humidity might be different from the humidity outside the room where a patient is sleeping.

[00187] In another example, ambient pressure can be the pressure that immediately surrounds or is external to the body.

[00188] In certain forms, ambient noise (e.g., acoustic) may be considered to be the background noise level in the room where a patient is located, in addition to, for example, noise generated by a TPR device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.

[00189] Automated Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable, for example, from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.

[00190] Continuous Positive Airway Pressure Therapy Petition 870260055359, dated 08 / 06 / 2026, page 63 / 176 55 / 67 (CPAP): Pressure-controlled breathing therapy in which the treatment pressure is approximately constant throughout a patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to the detection of indications of partial upper airway obstruction, and reduced in the absence of indications of partial upper airway obstruction.

[00191] Flow rate: The volume (or mass) of air delivered per unit time. The flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely, a quantity that has only magnitude. In other cases, a reference to flow rate will be a reference to a vector quantity, namely, a quantity that has both magnitude and direction. The flow rate may be given the symbol Q. Flow rate is sometimes abbreviated to simplify flow or airflow.

[00192] In the example of patient breathing, a flow rate may be nominally positive for the inspiratory portion of a patient's breathing cycle and, consequently, negative for the expiratory portion of a patient's breathing cycle. The total flow rate, Qt, is the airflow rate exiting the TPR device. The Vent flow rate, Qv, is the airflow rate exiting a vent to allow for the elimination of expired gases. The leak flow rate, Ql, is the leak flow rate from a patient interface system or other location. The respiratory flow rate, Qr, is the airflow rate that is received into the patient's respiratory system.

[00193] Humidifier. The word humidifier will be understood to mean a humidification device constructed and arranged, or Petition 870260055359, dated 08 / 06 / 2026, page 64 / 176 56 / 67 configured with a physical structure to have the capacity to deliver a therapeutically beneficial amount of water vapor (H2O) to an airflow to improve a patient's respiratory medical condition.

[00194] Leakage: The word leakage will be understood to mean an unintentional airflow. In one example, leakage may occur as a result of an incomplete seal between a mask and a patient's face. In another example, leakage may occur at an elbow with a rotating joint facing the environment.

[00195] Conducted noise (acoustic): Conducted noise in this document refers to noise that is carried to the patient through the pneumatic pathway, such as the air circuit and a patient interface, as well as the air within it. In one form, conducted noise can be quantified by measuring sound pressure levels at the end of an air circuit.

[00196] Radiated (acoustic) noise: Radiated noise in this document refers to noise that is carried to the patient by the ambient air. In one form, radiated noise can be quantified by measuring sound power / pressure levels of the object in question in accordance with ISO 3744.

[00197] Noise, ventilation (acoustic): Ventilation noise in this document refers to noise that is generated by airflow through any vents, such as ventilation holes in a patient interface.

[00198] Patient: An individual, whether or not suffering from a respiratory condition.

[00199] Pressure Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm2, and hectopascal. 1 cmH2O is equal to 1 gf / cm2 and is approximately 0.98 hectopascal. In this descriptive report, unless otherwise indicated, pressure is given in units of Pa (cmH2O). Petition 870260055359, dated 08 / 06 / 2026, page 65 / 176 57 / 67

[00200] The pressure at a patient interface is assigned the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the mask pressure Pm at the current time instant, is assigned the symbol Pt.

[00201] Pressure Breathing Therapy (PBT): The application of an air supply to an airway inlet at a treatment pressure that is typically positive relative to the atmosphere.

[00202] Ventilator. A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing. 5.9.2 Respiratory Cycle

[00203] Apnea: According to some definitions, apnea is considered to have occurred when airflow falls below a predetermined threshold for a duration, for example, 10 seconds. Obstructive apnea is considered to have occurred when, regardless of the patient's effort, some obstruction of the airway prevents airflow. Central apnea is considered to have occurred when apnea is detected that is due to a reduction in respiratory effort, or the absence of respiratory effort, regardless of whether the airway is obstructed. Mixed apnea occurs when a reduction or absence of respiratory effort coincides with an obstructed airway.

[00204] Respiratory rate: A patient's spontaneous breathing rate, generally measured in breaths per minute.

[00205] Duty cycle: The ratio of inhalation time, Ti to total breathing time, Ttot.

[00206] Effort (breathing): The work done by an individual who is spontaneously breathing and trying to breathe.

[00207] Expiratory portion of a breathing cycle: The period of Petition 870260055359, dated 08 / 06 / 2026, page 66 / 176 58 / 67 onset of expiratory flow compared to the onset of inspiratory flow.

[00208] Flow limitation: Flow limitation will be taken to be the state of relationships in a patient's breathing, in which an increase in effort by the patient does not result in a corresponding increase in flow. When flow limitation occurs during an inspiratory portion of the breathing cycle, it can be described as inspiratory flow limitation. When flow limitation occurs during an expiratory portion of the breathing cycle, it can be described as expiratory flow limitation.

[00209] Types of flow-limited inspiratory waveforms: (i) Flattened: To have an increase followed by a relatively flattened portion, followed by a drop. (ii) M-shaped: Having two local peaks, one on the leading edge and one on the trailing edge, and a relatively flattened portion between the two peaks. (iii) In chair shape: having a single local peak, where the peak is on the leading edge, followed by a relatively flattened portion. (iv) In reverse chair shape: which has a relatively flattened portion followed by a single local peak, where the peak is on the trailing edge.

[00210] Hypopnea: According to some definitions, hypopnea is considered to be a reduction in flow, but not an interruption of flow. In one form, hypopnea can be considered to have occurred when there is a reduction in flow below a threshold rate for a duration. Central hypopnea will be considered to have occurred when hypopnea is detected, which is due to a reduction in respiratory effort. In one form in adults, or the following, hypopneas can be considered: (i) a 30% reduction in patient breathing by Petition 870260055359, dated 08 / 06 / 2026, page 67 / 176 59 / 67 for at least 10 seconds plus an associated 4% desaturation; or (ii) a reduction in patient breathing (but less than 50%) for at least 10 seconds, with an associated desaturation of at least 3% or stimulation.

[00211] Hyperpnea: An increase in flow to a level greater than normal.

[00212] Inspiratory portion of a breathing cycle: The period from the start of inspiratory flow to the start of expiratory flow will be taken as the inspiratory portion of a breathing cycle.

[00213] Airway clearance: The degree to which the airway is open, or the extent to which the airway is open. A persistent airway is open. Airway clearance can be quantified, for example, with a value of one (1) being persistent, and a value of zero (0) being closed (obstructed).

[00214] Positive End-Expiratory Pressure (PEEP): The pressure above atmospheric pressure in the lungs that exists at the end of expiration.

[00215] Peak flow rate (Qpeak): The maximum flow rate value during the inspiratory portion of the respiratory flow waveform.

[00216] Respiratory flow rate, patient airflow rate, respiratory airflow rate (Qr): These terms can be understood as referring to the TPR device's estimate of respiratory flow rate, as opposed to true respiratory flow rate or true respiratory flow rate, which is the actual respiratory flow rate experienced by the patient, generally expressed in liters per minute.

[00217] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing, when no extra effort is applied. In principle, the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled) and therefore a single Petition 870260055359, dated 08 / 06 / 2026, page 68 / 176 60 / 67 tidal volume Vt can be defined as equal to any quantity. In practice, tidal volume Vt is estimated as some combination, for example, the average, of inspiratory volume Vi and expiratory volume Ve.

[00218] (inhalation) Time (Ti): The duration of the inspiratory portion of the respiratory flow rate waveform.

[00219] (exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow rate waveform.

[00220] (total) Time (Ttot): The total duration between the start of an inspiratory portion of a respiratory flow rate waveform and the start of the next inspiratory portion of the respiratory flow rate waveform.

[00221] Typical recent ventilation: The ventilation value around which recent Vent ventilation values ​​over some predetermined time scale tend to cluster, i.e., a measure of the central tendency of recent ventilation values.

[00222] Upper airway obstruction (UAO): includes both total and partial upper airway obstruction. This may be associated with a flow-limiting state, in which the flow rate increases only slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistor behavior).

[00223] Ventilation (Vent): A measurement of the rate of gas exchanged by a patient's respiratory system. Ventilation measurements may include either expiratory or inspiratory flow, per unit of time. When expressed as a volume per minute, this quantity is generally referred to as minute ventilation. Minute ventilation is sometimes simply referred to as volume, understood as volume per minute. 5.10 OTHER OBSERVATIONS Petition 870260055359, dated 08 / 06 / 2026, page 69 / 176 61 / 67

[00224] A portion of the disclosure of this patent document contains material subject to copyright protection. The copyright owner does not object to the exact reproduction by any individual of the patent document or patent disclosure to the extent that it is available in the files or records of a Patent Office, but otherwise retains all copyright.

[00225] Unless the context clearly indicates otherwise and when a range of values ​​is provided, it is understood that each intervention value, to the nearest tenth of the unit of the lower limit, between the lower and upper limits of that range, and any other intervention value or value indicated in that indicated range is encompassed within the technology. The upper and lower limits of those intervention ranges, which may independently be included in the intervention ranges, are also encompassed by the technology, subject to any limit specifically excluded in the cited range. When the cited range includes one or both limits, ranges that exclude one or both of those included limits are also included in the technology.

[00226] Furthermore, when a value or values ​​are indicated in this document as being implemented as part of the technology, it is understood that such values ​​may be approximate, unless otherwise indicated, and such values ​​may be used for any significant digit appropriate to the extent that a practical technical implementation may permit or require them.

[00227] Unless otherwise defined, all technical and scientific terms used in this document have the same meaning as that commonly understood by an individual of ordinary skill in the art to which this technology pertains. Although any methods and materials similar or equivalent to those described in this document may also be used in the practice or testing of the present technology, a limited number of Petition 870260055359, dated 08 / 06 / 2026, page 70 / 176 62 / 67 exemplary methods and materials are described in this document.

[00228] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless otherwise specified, any and all components described herein are understood to be capable of being produced and, in this manner, may be manufactured together or separately.

[00229] It should be noted that, as used in this document and the attached claims, the singular forms a, an and the include their plural equivalents, unless the context clearly indicates otherwise.

[00230] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of such publications. The publications discussed herein are provided for disclosures prior to the filing dates of this application only. Nothing herein should be construed as an admission that the present technology is not entitled to antedate such publication by virtue of a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may need to be independently verified.

[00231] The terms "comprises" and "that which comprises" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, used, or combined with other elements, components, or steps that are not expressly referenced. Petition 870260055359, dated 08 / 06 / 2026, page 71 / 176 63 / 67

[00232] The subject headings used in the detailed description are included only for the reader's ease of reference and should not be used to limit the subject matter of the entire disclosure or in the claims. The subject headings should not be used in constructing the scope of the claims or in the claim limitations.

[00233] Although the technology in this document has been described with reference to particular examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some examples, the terminology and symbols may imply specific details that are not necessary for practicing the technology. For example, although the terms first and second may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in a certain order, such ordering is not necessary. Those skilled in the art will recognize that such ordering may be modified and / or aspects thereof may be conducted simultaneously or even synchronously.

[00234] Therefore, it should be understood that various modifications can be made to the illustrative examples and that other arrangements can be devised without departing from the spirit and scope of the technology. 5.11 LIST OF NUMERICAL REFERENCES patient 1000 another patient 1002 another patient 1004 bed partner 1100 patient interface 3000 Petition 870260055359, dated 08 / 06 / 2026, page 72 / 176 64 / 67 RPT device 4000 external housing 4010 upper portion 4012 portion 4014 panel (or panels) 4015 chassis 4016 handle 4018 pneumatic block 4020 air filter 4110 inlet air filter 4112 outlet air filter 4114 silencer 4120 inlet silencer 4122 outlet silencer 4124 pressure generator 4140 blower 4142 drive machine 4144 anti-reflux valve 4160 air circuit 4170 air circuit 4171 supplemental oxygen 4180 electrical components 4200 Single Printed Circuit Board Assembly 4202 power supply 4210 input device 4220 central controller 4230 clock 4232 therapy device controller 4240 protection circuits 4250 memory 4260 transducer 4270 pressure sensor 4272 Petition 870260055359, dated 08 / 06 / 2026, page 73 / 176 65 / 67 Flow sensor 4274 Velocity sensor 4276 Data communication interface 4280 Remote external communication network 4282 Local external communication network 4284 Remote external device 4286 Local external device 4288 Output device 4290 Display actuator 4292 Display 4294 Algorithms 4300 Pre-processing module 4310 Pressure compensation algorithm 4312 Ventilation flow rate estimation 4314 Leakage flow rate estimation 4316 Leakage flow rate estimation 4316 Respiratory flow rate estimation 4318 Therapy motor module 4320 Phase determination algorithm 4321 Waveform determination algorithm 4322 Ventilation determination algorithm 4323 Inspiratory flow limitation determination algorithm 4324 Apnea / hypopnea determination algorithm 4325 Noise determination algorithm 4326 noise determination algorithm 4326 resonance determination algorithms 4326 noise determination algorithmairway clearance 4327 target ventilation determination algorithm 4328 therapy parameter determination algorithm 4329 therapy control module 4330 Petition 870260055359, dated 08 / 06 / 2026, page 74 / 176 66 / 67 algorithm 4340 method 4500 step 4520 step 4560 humidifier 5000 humidifier inlet 5002 humidifier outlet 5004 humidifier base 5006 reservoir 5110 conductive portion 5120 humidifier reservoir platform 5130 locking lever 5135 water level indicator 5150 humidifier transducer 5210 pressure transducers 5212 flow rate transducers 5214 temperature transducers 5216 humidity sensor 5218 heating element 5240 humidifier controller 5250 central humidifier controller 5251 heating element controller 5252 air circuit controller 5254 remote external device 5286 communication link 6020 server 6030 cloud communication platform 6040 medical devices 6062 medical devices 6064 setup step 7010 step 7012 step 7014 Petition 870260055359, dated 08 / 06 / 2026, page 75 / 176 67 / 67 Step 7016 Step 7018 Step 7020 Step 7022 Step 7024 Step 7026 Step 7028 Step 7030 Step 7032 Step 7034 Step 7036 Display screen 7050 Display screen 7052 Display screen 7054 Display screen 7056 Display screen 7058 Display screen 7060 Display screen 7062 Display screen 7064 Patient search service 8010 Patient search service 8020 MCS device 8024 Patient portal 8030 Petition 870260055359, dated 08 / 06 / 2026, page 76 / 176

Claims

1 / 10 CLAIMS 1. A respiratory pressure therapy system for providing continuous positive airway pressure (CPAP) using a device (4000) for a patient (1000), the system comprising: a flow generator (4140) configured to generate a supply of breathable gas for delivery to the patient (1000), wherein the breathable gas is emitted from the flow generator (4140) at a pressure level that is above atmospheric pressure; at least one sensor (4270, 4272, 4274, 4276) that is configured to measure a physical quantity while the breathable gas is supplied to the patient (1000);a computing device (4230) including a memory (4260) and at least one hardware processor, the memory (4260) stores instructions that, when executed by the at least one hardware processor, cause the computing device (4230) to: receive, from at least one sensor (4270, 4272, 4274, 4276), sensor data that are based on a measured physical property of the breathable gas supply; control, based on the received sensor data, the flow generator (4140) to adjust a property of the breathable gas supply that is delivered to the patient (1000); display, on a display device (4294, 4288), one or more questions; receive one or more user inputs for selectable answers indicating responses to the one or more questions; transmit the answers to a remote processing system (6030, 6040);receive, from the remote processing system, Petition 870260055359, dated 08 / 06 / 2026, page 77 / 176 2 / 10 information determined based on the transmitted responses; and adjust the operation of the respiratory pressure therapy system based on the received information; characterized in that the memory (4260) also stores instructions that, when executed by at least one hardware processor, lead the computing device (4230) to: perform configuration (7010) of the device (4000) before the initial use of the respiratory pressure therapy system by the patient (1000), wherein the configuration of the device (4000) includes associating the device (4000) with the patient (1000), requesting patient input (1000), and configuring device control settings (4000) based on responses entered by the patient (1000);and after a predetermined amount of time has elapsed since the device configuration (4000) has been performed: display (7018), on a display device (4294, 4288), one or more questions relating to demographic feedback and selectable answers to one or more questions relating to demographic feedback and one or more questions relating to subjective feedback and a selectable variable scale to provide an answer to one or more questions relating to subjective feedback; in response to the display of one or more questions, receive (7020) one or more user inputs for selectable answers indicating answers to one or more questions relating to demographic feedback and one or more user inputs for the variable scale indicating answers to one or more questions relating to subjective feedback;transmit (7022) the answers to one or more questions related to demographic feedback and the answers to one or more questions related to subjective feedback Petition 870260055359, dated 08 / 06 / 2026, page 78 / 176 3 / 10 to a remote processing system; receive (7030), from the remote processing system, settings for the respiratory pressure therapy system determined based on the transmitted answers; and adjust (7032), based on the received settings, the respiratory pressure therapy system control settings adjusted during device setup (4000).; 2. Respiratory pressure therapy system, according to claim 1, characterized in that the remote processing system is an on-demand cloud computing platform configured to perform machine learning using data received from a plurality of patients (1000).

3. Respiratory pressure therapy system, according to claim 1 or 2, characterized in that questions related to demographic feedback and subjective feedback are pre-stored in memory (4260).

4. A respiratory pressure therapy system, according to any one of claims 1 to 3, characterized in that one or more questions related to subjective feedback are received from the remote processing system.

5. Respiratory pressure therapy system, according to any one of claims 1 to 4, characterized in that it further comprises a patient interface (3000) configured to fit with at least one patient airway (1000) and supply breathable gas to the patient (1000).

6. Respiratory pressure therapy system, according to any one of claims 1 to 5, characterized in that the questions include at least one question regarding demographic information about the patient (1000) and at least one question regarding subjective feedback from the patient (1000) Petition 870260055359, dated 08 / 06 / 2026, page 79 / 176 4 / 10 regarding the use of the respiratory pressure therapy system.

7. Respiratory pressure therapy system, according to any one of claims 1 to 6, characterized in that it further comprises the remote processing system and the remote processing system is configured to determine individualized training instructions for the patient (1000) based on responses transmitted to the remote processing system.

8. Respiratory pressure therapy system, according to any one of claims 1 to 6, characterized in that it further comprises the remote processing system and the remote processing system is configured to determine personalized therapy for the patient (1000) based on responses transmitted to the remote processing system.

9. Respiratory pressure therapy system, according to any one of claims 1 to 8, characterized in that the computing device (4230) is further configured to, during the configuration of the apparatus (4000): display, on the display device (4294, 4288), an additional question related to demographic feedback and a selectable answer to the additional question related to demographic feedback and an additional question related to subjective feedback and a selectable answer to the additional question related to subjective feedback; in response to the display of one or more additional questions, receive user input for the selectable answers indicating answers to the additional questions related to demographic feedback and subjective feedback; transmit the answers to the additional questions to the remote processing system; Petition 870260055359, dated 08 / 06 / 2026, p.80 / 176 5 / 10 receive, from the remote processing system, settings for the respiratory pressure therapy system determined based on the transmitted responses; and adjust, based on the received settings, the respiratory pressure therapy system control settings adjusted during the device setup (4000).

10. Respiratory pressure therapy system, according to any one of claims 1 to 9, characterized in that the settings for the respiratory pressure therapy system and / or individualized training instructions are received by an application, website, email and / or a mobile device associated with the patient (1000).

11. Apparatus (4000) for treating a respiratory disorder in a patient (1000), the apparatus (4000) comprising: a display device (4294); a pressure generator (4140) configured to generate an airflow to treat the respiratory disorder; a transducer (4270) configured to generate a flow signal representing a property of the airflow; a memory (4260); a controller (4230), coupled to the display device (4294), the pressure generator (4140), the memory (4260), and the transducer (4270), the memory (4260) storing instructions that, when executed by at least one hardware processor, cause the controller (4230) to: receive the flow signal from the transducer (4270); control, based on the received flow signal, the pressure generator (4140) to adjust a property of the airflow; display, on the display device (4294), a feedback request;Petition 870260055359, dated 08 / 06 / 2026, page 81 / 176 6 / 10 receive, in response to the request, one or more inputs representing feedback; transmit feedback data based on the received inputs to a remote processing system (6030, 6040); receive, from the remote processing system (6030, 6040), analysis results determined based on the transmitted feedback data; and adjust the operation of the device (4000) based on the received analysis results; characterized by the fact that the memory (4260) also stores instructions which, when executed by the controller (4230), cause the controller (4230) to: perform configuration (7010) of the device (4000) before initial use by the patient (1000), wherein the configuration of the device (4000) includes associating the device (4000) with the patient (1000), requesting input from the patient (4000), and configuring the control settings of the device (4000) based on responses entered by the patient (1000);after a predetermined amount of time has elapsed since the device configuration (4000) was performed: display (7018), to the display device (4294, 4288), a request for demographic feedback and selectable responses to the request for demographic feedback and a request for subjective feedback and a selectable variable scale to provide a response to the request for subjective feedback; in response to the request for demographic feedback, receive (7020) one or more entries for the selectable responses that represent demographic feedback; in response to the request for subjective feedback, receive (7020) one or more entries for the variable scale that represents subjective feedback;transmit (7022) demographic and subjective feedback data determined based on one or more inputs received to a remote processing system; receive (7030), from the remote processing system, analysis results determined based on the transmitted demographic and / or subjective feedback data; and adjust (7032), based on the received analysis results, device control settings (4000) adjusted during device setup (4000).

12. Apparatus (4000), according to claim 11, characterized in that the controller (4230), the display device (4294) and the pressure generator (4140) are commonly housed.

13. Apparatus (4000), according to claim 11 or 12, characterized in that the adjustable control settings include a treatment pressure delivered to a patient mask (3000) coupled to the pressure generator (4140).

14. Apparatus (4000), according to any one of claims 11 to 13, characterized in that the controller (4230) is configured to transmit, with demographic and subjective feedback data, operational data of the apparatus (4000), and the analysis results are determined based on the demographic and subjective feedback data and the operational data of the apparatus (4000).

15. Device (4000), according to any one of claims 11 to 14, characterized in that the analysis results include individualized training instructions for the patient (1000). Petition 870260055359, dated 08 / 06 / 2026, page 83 / 176 8 / 10 16. Device (4000), according to any one of claims 11 to 15, characterized in that the analysis results include a personalized therapy for the patient (1000).

17. Processing system (4288, 6040, 6030, 4286), comprising: a memory (4260); and a computing system (4286, 6030, 6040) that includes at least one hardware processor coupled to the memory (4260), the memory (4260) storing instructions that, when executed by at least one hardware processor, lead the computing system to: receive (7024), from a medical device associated with a patient (1000), answers to questions; and perform (7026) analyses based on the answers received; characterized in that: the memory (4260) stores a plurality of demographic questions and a plurality of subjective questions; and the memory (4260) also stores instructions which, when executed by at least one hardware processor, cause the computing system (4286, 6030, 6040) to: transmit (7016) to the medical device at least one demographic question and at least one subjective question stored in memory (4260);receive (7024), from the medical device, answers to at least one demographic question and at least one subjective question transmitted to the medical device, wherein the answer to at least one subjective question is provided by an input on a variable scale; transmit, to a mobile device (4288) configured to run an application to communicate with the medical device, a notification indicating that unanswered questions are available; receive, from the mobile device, a request for the questions; in response to the request, transmit, to the mobile device, at least one demographic question and at least one objective question stored in memory (4260); receive, from the mobile device, answers to at least one demographic question and at least one objective question transmitted to the mobile device;and perform (7026) analyses to determine, based on (1) responses received from the medical device and mobile device and (2) responses received from a plurality of other medical devices (6062, 6064), individualized training instructions for the patient (1000) and personalized therapy using the medical device.; 18. Processing system (4288, 6040, 6030, 4286), according to claim 17, characterized in that the medical device is a respiratory treatment apparatus (4000).

19. Processing system (4288, 6040, 6030, 4286), according to claim 17 or 18, characterized in that the computing system (4286, 6030, 6040) is further configured to receive, from the medical device, answers to questions pre-stored in the medical device and answered using the medical device.

20. Processing system (4288, 6040, 6030, 4286), according to any one of claims 17 to 19, characterized in that questions are transmitted (7016) to the mobile device and / or medical device after a predetermined condition is met.

21. Processing system (4288, 6040, 6030, 4286), of Petition 870260055359, dated 08 / 06 / 2026, p. 85 / 176 10 / 10 according to claim 20, characterized in that the predetermined condition is a predetermined period of time after the medical device has been set up (7010) and / or a predetermined period of time after the medical device has been operated (7012) by the patient (1000). Petition 870260055359, dated 08 / 06 / 2026, p. 86 / 176

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