Method

Abstract

To solve the problem in which currently, when a patient receives a replacement respiratory therapy device, the prescription settings need to be manually ported.SOLUTION: Disclosed are systems and methods for automatically porting respiratory therapy settings to a new respiratory therapy device, where therapy settings and modes are automatically ported, translated and validated to a replacement respiratory therapy device.SELECTED DRAWING: Figure 9

Description

Technical Field

[0001] 1 Background of the Technology 1.1 Technical Field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and improving respiratory-related diseases. The present technology also relates to medical devices or apparatuses and their use. The present technology is also related to porting of respiratory settings between respiratory therapy devices.

Background Art

[0002] 1.2 Description of Related Technologies 1.2.1 The Human Respiratory System and Its Diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0003] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. When the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0004] A range of respiratory diseases exist. Certain diseases can be characterized by specific incidences (e.g., apnea, hypopnea, and hyperventilation).

[0005] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease. 1.2.2 Therapy

[0006] A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are used for the treatment of one or more of the above respiratory diseases. 1.2.2.1 Respiratory pressure therapy

[0007] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, continuous positive pressure ventilation therapy functions as an air sprint, thereby preventing upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following regarding the device used for treatment delivery, the patient may choose not to comply with the treatment: discomfort, difficulty of use, high cost, lack of aesthetic appeal.

[0008] Non-invasive ventilation (NIV) provides ventilation assistance to the patient through the upper airway and performs part or all of the respiratory function to provide respiratory assistance to the patient and / or maintain an appropriate oxygen level in the body. The ventilation assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory insufficiency in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0009] Invasive ventilation (IV) provides ventilation assistance to patients who are no longer able to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved. 1.2.2.2 Flow therapy

[0010] In all respiratory therapies, the delivery of a defined therapy pressure is not necessarily intended. In some respiratory therapies, perhaps the delivery of a defined respiratory volume by targeting a flow profile over a target duration is intended. In other cases, the interface to the patient's airway is "open" (seal released), and the respiratory therapy can only be used as an aid to the patient's own spontaneous breathing. In one embodiment, high flow therapy (HFT) is the provision of a continuous, heated, humidified air stream at a "therapy flow rate" that is maintained substantially constant throughout the respiratory cycle through a non-sealed or open patient interface. The therapy flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT is used for the treatment of OSA, CSR, COPD, and other respiratory disorders. As one mechanism of action, providing high flow air to the airway inlet improves ventilation efficiency because it enables the flushing or displacement of CO2 exhaled from the patient's anatomic dead space. For this reason, HFT may be referred to as dead space therapy (DST). In other flow therapies, the therapy flow rate may follow a profile that varies over the respiratory cycle.

[0011] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. A physician may prescribe the delivery of a continuous flow of oxygen-enriched gas to the patient's airway at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM) at a specified oxygen concentration (oxygen fraction in ambient air is 21% - 100%). 1.2.2.3 Supplemental Oxygen

[0012] For certain patients, a combination of oxygen therapy and respiratory pressure therapy or HFT can be obtained by adding supplemental oxygen to a pressurized air stream. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplemental oxygen. 1.2.3 Therapy System

[0013] These respiratory therapies can be provided by a treatment system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating the disease.

[0014] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source for breathing, and data management. 1.2.3.1 Patient Interface

[0015] The patient interface can be used, for example, to provide an interface to a breathing appliance to the wearer by providing an air flow to the airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby facilitating gas delivery at a sufficient distributed pressure together with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. 1.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0016] The respiratory pressure therapy (RPT) device can be used individually for the delivery of one or more of the above-mentioned treatments or as part of a system, for example, by operating the device to generate an air delivery flow to the interface to the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, the RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators. Examples of RPT devices include CPAP devices and ventilators. 1.2.3.3 Humidifier

[0017] When delivering an air flow without humidification, it can lead to drying of the airway. When a humidifier is used with an RPT device and a patient interface, humidified gas is generated, thus minimizing drying of the nasal mucosa and increasing patient airway comfort. Additionally, in a cooler climate, generally adding warm air to the facial area around the patient interface results in higher comfort compared to cold air. 1.2.3.4 Data Management

[0018] For clinical reasons, data may be obtained to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following one or more "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient needs to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, the provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate the usage rate over a given period, and compare this to the compliance rule. When a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0019] In a patient's treatment, there may be other ways to benefit from communicating treatment data to a third party or an external system.

[0020] In the case of existing processes for communicating and managing such data, one or more of high cost, time consumption, and susceptibility to errors may occur. 1.2.3.5 Mandibular Repositioning

[0021] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other providers that holds the mandible (lower jaw) in a forward position during sleep. The MRD is a removable device that is inserted into the mouth before sleep and removed after sleep. Therefore, the MRD is not designed for continuous wear applications. The MRD may be custom-made or manufactured in a standard form and includes an occlusal impression site designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension to the pharyngeal wall, reducing airway collapse and reducing palatal vibration.

[0022] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or fit with the teeth on the maxilla or maxilla bone, and a lower splint intended to engage or fit with the teeth on the maxilla or mandible. The upper splint and the lower splint are laterally connected to each other via a pair of connecting rods. This set of connecting rods is symmetrically fixed on the upper splint and the lower splint.

[0023] In such a design, the length of the connecting rod is selected such that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the level of protrusion of the mandible. The dentist can determine the level of protrusion according to the mandible, and as a result, the length of the connecting rod is determined.

[0024] There are also MRDs configured to push the mandible forward relative to the maxilla bone, and there are also those designed to hold the mandible in a forward position, such as other MADs like the ResMed Narval CC (registered trademark) MRD. This device also reduces or minimizes dental side effects and side effects of the temporomandibular joint (TMJ) between the temples and the mandible. Therefore, this device is configured to minimize or avoid any movement of one or more of the teeth. 1.2.3.6 Ventilation technology

[0025] Some forms of treatment systems may include a ventilation section for pushing out the exhaled carbon dioxide. This ventilation section can enable the gas flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings). 1.2.4 Screening, diagnosis, and monitoring systems

[0026] A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary diseases, and typically requires specialized clinical staff for system application in many cases. In a PSG, typically 15 to 20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyography (EMG)). For the PSG of sleep disordered breathing, it was necessary to observe the patient in a specialized hospital for two nights. That is, the first night was for pure diagnosis, and the second night was necessary for the titration of treatment parameters by a clinician. Therefore, the PSG is costly and has low convenience. Screening / diagnosis / monitoring of sleep disordered breathing is particularly unsuitable at home.

[0027] Generally, screening and diagnosis are to identify a disease based on its signs and symptoms. Usually, screening gives a true / false result indicating whether the patient's SDB requires further investigation, while diagnosis often provides clinically actionable information. Unlike screening and diagnosis, which tend to be one-time procedures, monitoring the course of a disease can be continued indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0028] Clinical experts can appropriately perform patient screening, diagnosis, or monitoring based on visual observation of PSG signals. However, there are situations where there is no clinical expert or payment to a clinical expert is not possible. There may be differences in opinions among clinical experts regarding a patient's condition. Furthermore, certain clinical experts may apply different criteria depending on the time.

Summary of the Invention

Means for Solving the Problems

[0029] 2 Brief Description of the Technology This technology is related to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0030] The first aspect of this technology is related to a device used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases.

[0031] Another aspect of this technology is related to a method used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory disorders.

[0032] One aspect of a specific form of this technology is to provide a method and / or device for improving patient compliance with respect to respiratory therapy.

[0033] One form of this technology includes a method and system for automatically porting respiratory therapy settings for a new respiratory therapy device. Currently, when a patient receives a replacement respiratory therapy device, an upgraded respiratory therapy device, or an additional or new type of respiratory therapy device, the prescription settings need to be manually ported, which requires human intervention.

[0034] For example, when a patient already has an existing device and prescription (REPAP) and wants to acquire a new device, the patient needs to order the new device from a provider. The provider may need to install settings or manually update its cloud-based database to add the new device and confirm that the patient's prescription is still valid. Thus, generally, all the patient can do is order a new device from the current provider who has the patient's prescription information, without facing difficult or long installation processes.

[0035] According to another aspect of one form of the present technology, a system can check a treatment quality indicator (e.g., an oxygen measurement reading) to determine whether the treatment prescription settings should be automatically ported. For example, when performing an automatic port of treatment settings, there is a problem that the prescription should not be ported when, for example, the patient's prescription is of low treatment quality below optimal. Thus, a system and method are disclosed for automatically checking and determining whether a patient's prescription is valid (e.g., by checking the treatment quality indicator and effectiveness indicator disclosed herein).

[0036] Another aspect of one form of the present technology is characterized by automatically porting a prescription after checking the prescription date, converting the settings between ventilators, and checking for changes in patient information or other relevant elements. As described herein, problems can arise when two different types of models are used when automatically porting the above prescription treatment settings. Thus, a system and method for converting treatment settings herein are disclosed.

[0037] Another aspect of one form of the present technology is a method for automatically determining changes in a patient's condition. To automatically determine changes in a patient's condition, in updating a prescription (non-limiting examples include weight, age, BMI, facial changes), it is necessary to perform the update through image recognition software indicating changes, voice changes through voice analysis, or other relevant patient changes (which can be automatically detected or detected through the application of a questionnaire).

[0038] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed with a peripheral shape that is complementary to the intended wearer's shape.

[0039] One aspect of one form of the present technology is a method of manufacturing the device.

[0040] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience using this type of medical device.

[0041] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).

[0042] One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soap water in the patient's home, and no special cleaning equipment is required. One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soap water in the patient's home, and no special cleaning equipment is required.

[0043] The described methods, systems, devices, and apparatuses can be embodied to improve functions in a processor (e.g., the functions of a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory therapy device). Further, the described methods, systems, devices, and apparatuses enable improvements in the technical field of automatic management, monitoring, and / or treatment of respiratory conditions (e.g., sleep-disordered breathing).

[0044] Of course, some of the above aspects can form sub-aspects of the present technology. Also, various ones of the sub-aspects and / or aspects can be combined in various ways to constitute further aspects or sub-aspects of the present technology.

[0045] Other features of the technology will become apparent in light of the information contained in the following detailed description, summary, drawings, and claims.

[0046] Another aspect of the technology may include a prescription database using a prescription treatment setting. These prescription treatment settings are referenced against a patient account ID, and the patient account ID includes a unique identifier for each patient in the database communicating with the prescription server, a first respiratory therapy device, a second respiratory therapy device, an interface, and a memory including a machine-readable medium. The machine-readable medium includes machine-executable code in which instructions for performing a method are stored, and the control system is connected to the memory including one or more processors, and the control system is configured to execute the machine-executable code to cause the control system to: receive from the interface an input indicating that the patient wishes to port settings from the first respiratory therapy device; receive through the interface the account ID associated with the patient and the hardware identifier of the first respiratory therapy device; and send a request including the account ID and the hardware identifier to the prescription server to retrieve prescription treatment settings from the prescription server; receive from the prescription server the prescription treatment settings referenced against the account ID when the hardware identifier is activated; and store the prescription treatment settings in the memory of the second respiratory therapy device.

[0047] In another aspect of the technology, the prescription treatment settings further include: retrieving a respiratory quality indicator referenced against the account ID based on a respiratory therapy data output from the first respiratory device; determining whether the respiratory quality indicator exceeds a threshold; and if the respiratory quality indicator is below the threshold, flagging the patient for follow-up and rejecting the request to port the prescription treatment settings.

[0048] In another aspect of the present technology, the respiratory quality indicator is the apnea hypopnea index. In another aspect of the present technology, receiving a prescription treatment setting from the prescription server further includes: determining a time window that has elapsed since the last update of the prescription treatment setting; determining whether the time window exceeds a threshold; if the time window exceeds the threshold, flagging the patient for follow-up and rejecting the request to port the prescription treatment setting.

[0049] In another aspect of the present technology, the prescription treatment setting further includes: requesting a set of information from the patient; determining, based on the evaluation of the information, whether a significant change has occurred in relation to the patient prescription treatment setting; and if a significant change has occurred, flagging the patient for follow-up and rejecting the request to port the prescription treatment setting.

[0050] In another aspect of the present technology, the set of information includes at least one of the following: weight change, BMI change, muscle tension change. In another aspect of the present technology, receiving a prescription treatment setting from the prescription server further includes: requesting a set of oximeter data outputs from a pulse oximeter; determining, based on the processing of the oximeter data, whether the prescription treatment setting should be updated; and if the setting should not be updated, flagging the patient in the prescription treatment database for follow-up and rejecting the request to port the prescription treatment setting.

[0051] In another aspect of the present technology, the set of information includes voice data received through a microphone, and the processing of the voice data determines whether there is a significant change in the patient's tone. In another aspect of the present technology, the set of information includes the facial image data, and a significant facial change is identified by comparing the facial image data with pre-captured image data. In another aspect of the present technology, the significant facial change indicates a significant change in BMI.

[0052] In another aspect of the technology, the prescription treatment settings are received via a cellular antenna connected to the first respiratory treatment device.

[0053] In another aspect of the technology, the prescription treatment settings are received via a Bluetooth® or Wi-Fi connection to a device connected to the first respiratory treatment device, and the prescription treatment settings are encrypted from the prescription server to the first respiratory treatment device.

[0054] In another aspect of the technology, the prescription treatment settings include minimum and maximum pressures and treatment modes, and the general treatment settings include humidity, RAMP, EPR, or treatment modes (e.g., CPAP, APA, bi-level).

[0055] In another aspect of the technology, receiving, through the interface, the account ID associated with the patient's account and the serial number associated with the second respiratory treatment device further includes: displaying a code on a display of the first respiratory treatment device; requesting input of the code on the interface; and, when the code is validated, receiving only the general settings and the prescription treatment settings.

[0056] In another aspect of the technology, receiving the prescription treatment settings further includes performing a conversion of the prescription treatment settings by a predetermined conversion factor based on a difference between the first and second respiratory treatment devices.

[0057] A system according to another aspect of the present technology includes: a prescription database using a prescription treatment setting, wherein the prescription treatment setting is referenced to a patient account ID, and the patient account ID includes a unique identifier for each patient in the database communicating with a prescription server, the prescription database; a patient database communicating with a patient server and including general patient data referenced to a set of patient account IDs; a first respiratory therapy device; an interface; a memory including a machine-readable medium, the machine-readable medium including machine-executable code, and instructions for performing a method are stored on the machine-executable code, the memory; a control system connected to the memory including one or more processors, the control system being configured to execute the machine-executable code to cause the control system to: receive, from the interface, an input indicating that a patient wishes to port settings from a second respiratory therapy device; receive, through the interface, an account ID associated with the patient and a serial number associated with the second respiratory therapy device; and send a request including the account ID and the serial number to the patient server to retrieve a prescription treatment setting from the prescription server; when the serial number is activated, receive, from the patient server, the prescription treatment setting sent from the prescription server referenced to a prescription ID referenced to the account ID; and store the prescription treatment setting in the memory of the second respiratory therapy device.

[0058] A method according to another aspect of the present technology includes: receiving from an interface an input that a patient desires to port a prescription treatment setting to a respiratory therapy device; receiving from the interface an account ID associated with the patient and a serial number associated with the respiratory therapy device; sending a request including the account ID and the serial number to a prescription server to retrieve a prescription treatment setting from the prescription server; receiving, if the serial number is activated, the prescription treatment setting referenced for the account ID from the prescription server; and storing the prescription treatment setting in the memory of the respiratory therapy device.

[0059] In another aspect of the present technology, storing the prescription treatment setting in the memory of the respiratory therapy device further includes storing the prescription treatment setting for a single use session. In the method of claim 19, storing the prescription treatment setting in the memory of the respiratory therapy device further includes storing the prescription treatment setting for a single use session.

[0060] In another aspect of the present technology, a single use session includes deleting the prescription treatment setting in the memory of the respiratory therapy device after a specific time window has expired.

[0061] In another aspect of the present technology, a single use session includes deleting the prescription treatment setting in the memory of the respiratory therapy device after the respiratory therapy device has been powered off.

[0062] In another aspect of the present technology, a single use session includes deleting the prescription treatment setting in the memory of the respiratory therapy device after 24 hours or after receiving a notification that the patient has checked out of the affiliated hotel.

[0063] A method according to another aspect of the present technology includes: a request from a patient computing device to port a prescription treatment setting including an account ID associated with the patient and a serial number associated with the respiratory treatment device to the respiratory treatment device. Receiving, at a prescription server of ; querying, by the prescription server, the prescription database for the account ID and the serial number and retrieving a set of prescription treatment settings from the prescription database; processing, by the prescription server, the serial number to determine whether the serial number is validly associated with the account ID; and, if the serial number is validated, transmitting the set of prescription treatment settings referenced for the account ID to the respiratory treatment device.

[0064] A system according to another aspect of the present technology includes: a prescription database using prescription treatment settings, the prescription treatment settings being referenced for a patient account ID, the patient account ID including a unique identifier for each patient in the database communicating with a prescription server, the prescription database; an interface; an input module that receives, from the interface, an input indicating that the patient wants to port settings from a first respiratory treatment device; a receiving interface module that receives, through the interface, an account ID associated with the patient and a hardware identifier of the first respiratory treatment device; a transmitting module that transmits a request including the account ID and the hardware identifier to the prescription server to retrieve prescription treatment settings from the prescription server; a receiving server module that receives, from the prescription server, the prescription treatment settings referenced for the account ID when the hardware identifier is validated; and a storage module that stores the prescription treatment settings in the memory of the second respiratory treatment device.

[0065] A system according to another aspect of the present technology includes: a prescription database using a prescription treatment setting, wherein the prescription treatment setting is referenced to a patient account ID, and the patient account ID includes a unique identifier for each patient in the database communicating with a prescription server, the prescription database; a patient database communicating with a patient server and including general patient data referenced to a set of patient account IDs; an interface; an input module receiving an input from the interface indicating that a patient wants to port settings from a second respiratory therapy device; a receiving interface module receiving, through the interface, an account ID associated with the patient and a serial number associated with the second respiratory therapy device; a transmitting module transmitting a request including the account ID and the serial number to the patient server to retrieve a prescription treatment setting from the prescription server; a receiving server module receiving, from the patient server, the prescription treatment setting transmitted from the prescription server referenced to a prescription ID referenced to the account ID when the serial number is activated; a saving module saving the prescription treatment setting in the memory of the second respiratory therapy device.

[0066] Another aspect of the present technology includes a computer program product including instructions that, when executed by a computer, cause the computer to perform the steps of the above-described method.

Brief Description of the Drawings

[0067] 3 Brief Description of the Drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals indicate the following like elements: 3.1 Treatment System

[0068]

Figure 1A

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Figure 1B

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Figure 1C

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Figure 2A

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Figure 3A

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Figure 4A

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Figure 4B

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Figure 4C

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Figure 4D

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Figure 4E

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Figure 5A

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Figure 5B

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Figure 6A

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Figure 7A

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Figure 7B

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Figure 8

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Figure 9

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Figure 10

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Figure 11

Best Mode for Carrying Out the Invention

[0087] 4 Detailed Description of Embodiments of the Technology Before explaining the technology in more detail, it should be understood that the technology is not limited to the specific embodiments that may be described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0088] The following description is provided in relation to various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. Additionally, any single feature or combination of features in any of these embodiments may constitute a further embodiment. 4.1 Treatment

[0089] In one form, the technology includes a method of treating a respiratory disease. The method includes the step of applying positive pressure to the entrance of the airway of patient 1000.

[0090] In certain embodiments of the technology, an air supply at positive pressure is provided to the nasal passage of the patient via one or both of the nostrils.

[0091] In certain embodiments of the technology, mouth breathing is restricted, limited, or prevented. 4.2 Treatment System

[0092] In one form, the technology includes an apparatus or device for the treatment of a respiratory disorder. The apparatus or device may include an RPT device 4000 that supplies compressed air to patient 1000 via an air circuit 4170 to a patient interface 3000 or 3800. 4.3 Patient Interface

[0093] A non-invasive patient interface 3000 according to one aspect of the technology includes the following functional modalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, ventilation holes 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional modalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functional modalities. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of air at positive pressure to the airway.

[0094] The non-sealing patient interface 3800 is in the form of a nasal cannula and includes nasal cannulas 3810a and 3810b. The nasal cannulas 3810a and 3810b can deliver air to each nasal cavity of the patient 1000. Such nasal prongs often do not form a seal with the inner or outer skin surface of the nostrils. The air to the nasal prongs is delivered from one or more air supply lumens 3820a and 3820b. These are connected to the nasal cannula 3800. The lumens 3820a and 3820b extend from the nasal cannula 3800, and the nasal cannula 3800 extends to an RT device that generates an air flow at a high flow rate. The non-sealing patient interface 3800 is provided with a "vent hole" through which excess air flow escapes to the atmosphere. This "vent hole" is a passage between the ends of the prongs 3810a and 3810b of the cannula 3800 and extends to the atmosphere through the patient's nasal cavity.

[0095] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0096] The patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the surroundings.

[0097] The patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the surroundings.

[0098] The patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the surroundings. 4.4 RPT Device

[0099] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an air flow that is delivered to a patient's airway for treatment of one or more of the respiratory states described anywhere in the present document, for example.

[0100] In one form, the RPT device 4000 is constructed and arranged to be able to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O or at least 10 cmH2O or at least 20 cmH2O. 4.4.1 RPT Device Electrical Components 4.4.1.1 Power Supply

[0101] The power supply 4210 can be disposed inside or outside the external housing 4010 of the RPT device 4000.

[0102] In one form of the present technology, the power supply 4210 supplies power only to the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000. 4.4.1.2 Input Device

[0103] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials that enable a human to interact with the device. The buttons, switches, or dials can be physical devices or software devices that can be accessed via a touch screen. The buttons, switches, or dials can be physically connected to the external housing 4010 in one form or, alternatively, wirelessly communicate with a receiver electrically connected to the central controller 4230 in another form.

[0104] In one form, the input device 4220 can be constructed and arranged to enable a human to select values and / or menu options. 4.4.1.3 Central Controller

[0105] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0106] Suitable processors can include processors based on the ARM® Cortex®-M processor from ARM Holdings, x86 INTEL processors (e.g., S®32 series microcontrollers from STMicroelectronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., STR9 series microcontrollers from ST MICROelectronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by TEXAS INSTRUMENTS) can also be suitable.

[0107] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0108] In one form, the central controller 4230 is an application-specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0109] The central controller 4230 can be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and the humidifier 5000.

[0110] The central controller 4230 can be configured to provide output signal(s) to one or more of the output device 4290, the treatment device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0111] In some forms of the present technology, the central controller 4230 is configured to implement one or more of the methods described herein (e.g., expressed as one or more algorithms 4300 recorded as a computer program on a non-transitory computer-readable recording medium such as the memory 4260). In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some of the methods may be performed by remotely located devices. For example, a remotely located device may determine control settings for a ventilator or detect respiratory-related events by analyzing recorded data (e.g., from any of the sensors described herein). 4.4.1.4 Clock

[0112] The RPT device 4000 may include a clock 4232 connected to the central controller 4230. 4.4.1.5 Therapy Device Controller

[0113] In one form of the present technology, the therapy device controller 4240 is the therapy control module 4330 and forms part of the algorithm 4300 executed by the central controller 4230.

[0114] In one form of the present technology, the therapy device controller 4240 is a dedicated motor control integrated circuit For example, in one form, an MC33035 brushless DC motor controller manufactured by ONSEMI is used. 4.4.1.6 Protection Circuit

[0115] One or more protection circuits 4250 according to the present technology may include an electrical protection circuit, a temperature and / or pressure safety circuit. 4.4.1.7 Memory

[0116] According to one aspect of the present technology, the RPT device 4000 includes a memory 4260 (e.g., non-volatile memory). In some aspects, the memory 4260 may include a battery-backed static RAM. In some aspects, the memory 4260 may include a volatile RAM.

[0117] The memory 4260 may be disposed on the PCBA 4202. The memory 4260 may take the form of an EEPROM or a NAND flash.

[0118] Additionally or alternatively, the RPT device 4000 includes a removable memory 4260 (e.g., a memory card manufactured according to the Secure Digital (SD) standard).

[0119] In one aspect of the present technology, the memory 4260 functions as a non-transitory computer-readable recording medium. On this recording medium, computer program instructions (e.g., one or more algorithms 4300) representing one or more of the methods described herein are recorded. 4.4.1.8 Data Communication System

[0120] In one aspect of the present technology, a data communication interface 4280 is provided and connected to the central controller 4230. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0121] In one aspect, the data communication interface 4280 is part of the central controller 4230. In another aspect, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0122] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can use wired communication (e.g., via Ethernet® or fiber optic) or a wireless protocol (e.g., CDMA, GSM®, LTE) to connect to the Internet.

[0123] In one form, the local external communication network 4284 uses one or more communication standards (e.g., Bluetooth® or consumer infrared protocol).

[0124] In one form, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In one form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 can be accessible by appropriately authorized individuals (e.g., clinicians).

[0125] The local external device 4288 can be a personal computer, a mobile phone, a tablet, or a remote control. 4.4.1.9 Optional display, output devices including alarms

[0126] The output device 4290 according to the present technology can take one or more forms of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light emitting diode (LED) display. 4.4.1.9.1 Display driver

[0127] The display driver 4292 receives as input the characters, symbols, or images to be displayed on the display 4294 and converts them into commands to display these characters, symbols, or images on the display 4294. 4.4.1.9.2 Display

[0128] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 can be an 8-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the digit "0") into eight logic signals indicating whether each of the eight segments should be activated to display the specific character or symbol. 4.4.2 RPT Device Algorithm

[0129] As described above, in some forms of the present technology, the central control device 4230 can be configured to embody one or more algorithms 4300 expressed as a computer program recorded in a non-transitory computer-readable recording medium (e.g., the memory 4260). These algorithms 4300 are generally grouped into groups called modules. 4.4.2.1 Preprocessing Module

[0130] The preprocessing module 4310 according to one form of the present technology receives, as input, signals from the converter 4270 (e.g., the flow sensor 4274 or the pressure sensor 4272), and performs one or more process steps for calculating one or more output values. These output values are used as input to another module (e.g., the treatment engine module 4320).

[0131] In one form of the present technology, the output values include the interface pressure Pm, the respiratory flow rate Qr, and the leakage flow rate Ql.

[0132] In various forms of the present technology, the preprocessing module 4310 includes one or more of the following algorithms: interface pressure estimation 4312, ventilation flow rate estimation 4^{3}14, leakage flow rate estimation 4316, and respiratory flow rate estimation 4318. 4.4.2.1.1 Interface Pressure Estimation

[0133] In one aspect of the present technology, the interface pressure estimation algorithm 4312 receives, as an input, a signal indicating the pressure (device pressure Pd) in the pneumatic path near the outlet of the pneumatic block from the pressure sensor 4272, and receives, as an input, a signal indicating the flow rate (device flow rate Qd) of the air flow exiting the RPT device 4000 from the flow rate sensor 4274. The device flow rate Qd that does not include any auxiliary gas 4180 can be used as the total flow rate Qt. The interface pressure algorithm 4312 estimates the pressure drop ΔP through the air circuit 4170. The dependence of the pressure drop ΔP on the total flow rate Qt can be modeled for a specific air circuit 4170 by the pressure drop characteristic ΔP(Q). Next, the interface pressure estimation algorithm 4312 provides, as an output, the estimated pressure Pm in the patient interface 3000 or 3800. The pressure Pm in the patient interface 3000 or 3800 can be estimated as the value obtained by subtracting the air circuit pressure drop ΔP from the device pressure Pd. 4.4.2.1.2 Estimation of ventilation flow rate

[0134] In one aspect of the present technology, the ventilation flow rate estimation algorithm 4314 receives, as an input, the estimated pressure Pm in the patient interface 3000 or 3800 from the interface pressure estimation algorithm 4312, and estimates the ventilation flow rate Qv of the air from the ventilation holes 3400 in the patient interface 3000 or 3800. The dependence of the ventilation flow rate Qv on the interface pressure Pm at a specific ventilation part 3400 during use can be modeled by the ventilation characteristic Qv(Pm). 4.4.2.1.3 Estimation of leakage flow rate

[0135] In one aspect of the present technology, the leakage flow rate estimation algorithm 4316 receives the total flow rate Qt and the ventilation flow rate Qv as inputs, and provides, as an output, an estimation of the leakage flow rate Ql. In one aspect, the leakage flow rate estimation algorithm estimates the leakage flow rate Ql by calculating the difference average between the total flow rate Qt and the ventilation flow rate Qv over a period long enough to include several respiratory cycles (e.g., about 10 seconds).

[0136] In one form, the leak flow rate estimation algorithm 4316 receives the total flow rate Qt, the ventilation flow rate Qv, and the estimated pressure Pm in the patient interface 3000 or 3800 as inputs, and provides the leak flow rate Ql as an output by calculating the leak conductance and determining the leak flow rate Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered non-ventilation flow rate equal to the difference between the total flow rate Qt and the ventilation flow rate Qv and the low-pass filtered square root of the pressure Pm, and the low-pass filter time constant has a sufficient value that includes several respiratory cycles (e.g., about 10 seconds). The leak flow rate Ql can be estimated as a function of the product of the leak conductance and the pressure Pm. 4.4.2.1.4 Respiratory Flow Rate Estimation

[0137] In one form of the present technology, the respiratory flow rate estimation algorithm 4318 receives the total flow rate Qt, the ventilation flow rate Qv, and the leak flow rate Ql as inputs, and estimates the air respiratory flow rate Qr to the patient by subtracting the ventilation flow rate Qv and the leak flow rate Ql from the total flow rate Qt. 4.4.2.2 Treatment Engine Module

[0138] In one form of the present technology, the treatment engine module 4320 receives one or more of the pressure Pm in the patient interface 3000 or 3800 and the air respiratory flow rate Qr to the patient as inputs, and provides one or more treatment parameters as outputs.

[0139] In one form of the present technology, the treatment parameter is the treatment pressure Pt.

[0140] In one form of the present technology, the treatment parameters are one or more of the amplitude of the pressure change, the base pressure, and the target ventilation.

[0141] In various forms, the treatment engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and treatment parameter determination 4329. 4.4.2.2.1 Phase Determination

[0142] In one form of the technology, the RPT device 4000 does not determine a phase.

[0143] In one form of the technology, the phase determination algorithm 4321 receives, as an input, a signal indicative of the respiratory flow rate Qr and provides, as an output Φ, the phase of the current respiratory cycle of the patient 1000.

[0144] In some forms, the phase output Φ, known as discrete phase determination, is a discrete variable. According to one embodiment of the discrete phase determination, a binary phase output Φ having a value of inspiration or expiration is obtained. This value is represented as values of, for example, 0 revolutions and 0.5 revolutions respectively when the start of each of the spontaneous inspiration and expiration is detected. The RPT device 4000 that "triggers" and "cycles" effectively performs discrete phase determination. This is because the trigger point and the cycle point are the instants at which the phase changes from expiration to inspiration and from inspiration to expiration respectively. In one embodiment of the binary phase determination, the phase output Φ has a discrete value of 0 when the respiratory flow rate Qr has a value exceeding a positive threshold (thereby "triggering" the RPT device 4000), and has a discrete value of 0.5 revolutions when the value of the respiratory flow rate Qr is a negative value greater than a negative threshold (thereby "cycling" the RPT device 4000). The inspiratory time Ti and the expiratory time Te can be typical values estimated over many respiratory cycles of the time spent with the phase Φ equal to 0 (indicating inspiration) and 0.5 (indicating expiration) respectively.

[0145] Another embodiment of discrete phase determination yields a three-valued phase output Φ with one of the values of inspiration, apnea during inspiration, and expiration.

[0146] In other forms, the phase output Φ, known as continuous phase determination, is a continuous variable and varies, for example, between 0 revolutions to 1 revolution or 0 to 2π radians. The RPT device 4000 that performs continuous phase determination can be triggered and cycled when the continuous phase reaches 0 revolutions and 0.5 revolutions respectively. In one embodiment of continuous phase determination, the continuous value Φ of the phase is determined using fuzzy logic analysis of the respiratory flow rate Qr. The continuous values of the phase executed in this embodiment are often called "fuzzy phases". In one embodiment of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow rate Qr: 1. If the respiratory flow rate increases rapidly after reaching zero, the phase is 0 revolutions. 2. If the respiratory flow rate is a large positive value and stable, the phase is 0.25 revolutions. 3. If the respiratory flow rate is zero and decreases rapidly, the phase is 0.5 revolutions. 4. If the respiratory flow rate is a large negative value and stable, the phase is 0.75 revolutions. 5. If the respiratory flow rate is zero and stable, and the absolute value of the 5-second low-pass filtered respiratory flow rate is large, the phase is 0.9 revolutions. 6. If the respiratory flow rate is positive and the phase is expiration, the phase is 0 revolutions. 7. If the respiratory flow rate is negative, the phase is inspiration, and the phase is 0.5 revolutions. 8. If the absolute value of the 5-second low-pass filtered respiratory flow rate is large, the phase increases at a constant rate equal to the patient's respiratory rate low-pass filtered by a time constant of 20 seconds.

[0147] The output of each rule can be represented as a vector where the phase is the result of the rule and the magnitude is the fuzzy range for which the rule is true. Fuzzy ranges such as "large" or "stable" for the respiratory flow rate are determined by appropriate membership functions. The results of the rules are represented as vectors and then combined by several functions such as taking the centroid. In such combinations, the rules may be weighted equally or weighted in different ways.

[0148] In another embodiment of the continuous phase determination, the phase Φ is first individually estimated from the respiratory flow rate Qr as described above, similar to the inhalation time Ti and the exhalation time Te. Then, the continuous phase Φ at any instant is determined as the value obtained by adding half of the ratio of the inhalation time Ti elapsed from the preceding trigger instant or the ratio of the exhalation time Te elapsed from the preceding cycle instant for 0.5 rotations (whichever is the more recent instant). 4.4.2.2.2 Waveform determination

[0149] In one form of the present technology, the treatment parameter determination algorithm 4329 provides a substantially constant treatment pressure throughout the patient's respiratory cycle.

[0150] In another form of the present technology, the treatment control module 4330 controls the pressure generator 4140 to provide a treatment pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to the waveform template Π(Φ).

[0151] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ). The waveform template has values within the range of [0,1] for the range of phase values Φ provided by the phase determination algorithm 4321 that is intended to be used by the treatment parameter determination algorithm 4329.

[0152] In one form, suitable for a phase that takes values discretely or continuously, the waveform template Π(Φ) is a square wave template, having a value of 1 for phase values up to 0.5 rotations and a value of 0 for phase values exceeding 0.5 rotations. In one form, suitable for a phase that takes values continuously, the waveform template Π(Φ) includes two smoothly curved portions (i.e., a smooth (e.g., rising cosine) rise from 0 to 1 for phase values up to 0.5 rotations and a smooth (e.g., exponential) fall from 1 to 0 for phase values exceeding 0.5 rotations). In one form, suitable for a phase that takes values continuously, the waveform template Π(Φ) is based on a square wave but has a smooth rise from 0 to 1 for phase values up to a “rise time” lower than 0.5 rotations and a smooth fall from 1 to 0 for phase values within the “fall time” after 0.5 rotations, having a “fall time” lower than 0.5 rotations.

[0153] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates according to the settings of the RPT device. Each waveform template Π(Φ) in the library can be provided as a look-up table value Π for the phase value Φ. In other forms, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) “on the fly” using a predetermined functional form (possibly parameterized by one or more parameters (e.g., the time constant of an exponentially curved portion)). The parameters of the functional form may be predetermined or may depend on the current state of the patient 1000.

[0154] In some forms of the present technology suitable for discrete binary phases of inspiration (Φ = 0 rotations) or expiration (Φ = 0.5 rotations), the waveform determination algorithm 4322 calculates the waveform template Π "on the fly" as a function of the discrete phase Φ and time t measured from the most recent trigger instant. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ,t) in two parts (inspiration and expiration) as follows. JPEG0007717234000001.jpg1983

[0155] Here, Πi(t) and Πe(t) are the inspiration and expiration parts of the waveform template Π(Φ,t). In one such form, the inspiration part Πi(t) of the waveform template is a smooth rise from 0 to 1 parameterized by the rise time, and the expiration part Πe(t) of the waveform template is a smooth fall from 1 to 0 parameterized by the fall time. 4.4.2.2.3 Ventilation determination

[0156] In one form of the present technology, the ventilation determination algorithm 4323 receives the respiratory flow Qr as an input and determines a measurement indicative of the current patient ventilation Vent.

[0157] In some embodiments, the ventilation determination algorithm 4323 determines a measurement of the ventilation Vent, which is an estimate of the actual patient ventilation. As one such embodiment, it may take half the absolute value of the respiratory flow Qr, which is optionally filtered by a low-pass filter (e.g., a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz).

[0158] In another embodiment, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is highly proportional to the actual patient ventilation. In one such embodiment, the peak respiratory flow rate Qpeak is estimated during the inspiratory portion of the cycle. Through the above and many other procedures including sampling of the respiratory flow rate Qr, a measurement that is highly proportional to ventilation is obtained, but in these measurements, the variation in the flow waveform shape is not very large (where the shapes of two breaths are taken to be the same as when the flow waveforms of the breaths normalized in time and amplitude are similar). To give some simple examples, there are the median of the positive respiratory flow rates, the median of the absolute values of the respiratory flow rates, and the standard deviation of the flow rates. Any linear combination of any order statistics of the absolute values of the respiratory flow rates using positive coefficients (and even some using both positive and negative coefficients) is approximately proportional to ventilation. As another example, it is the average of the respiratory flow rates at the central K percentage (with respect to time) of the inspiratory portion, where 0 < K < 1. When the flow shape is constant, there are any number of measurements that are highly proportional to ventilation. 4.4.2.2.4 Determination of Inspiratory Flow Limitation

[0159] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the range of inspiratory flow limitation.

[0160] In one embodiment, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow rate signal Qr as an input and provides, as an output, a measure of the range in which the inspiratory portion of the breath indicates an inspiratory flow limitation.

[0161] In one form of the present technology, the inhalation portion of each breath is identified by a zero-crossing detector. A plurality of (e.g., 65) equally spaced points that indicate time points are interpolated by an interpolator along the inhalation flow-rate vs. time curve for each breath. Subsequently, the curve described by these points is scaled by a scaler to have unit length (duration / period) and unit area, thereby removing the effects due to changes in respiratory rate and depth. Next, the scaled breath is compared in a comparator with a pre-stored template (similar to the inhalation portion of the breath shown in FIG. 6A) that represents a normal unobstructed breath. At any time during inhalation, a deviation of the breath from this template due to, for example, cough, exhalation, swallowing, and hiccups as determined by the test element exceeds a specified threshold (typically, 1 scale unit) then the breath is rejected. For the data without rejection, the moving average of the first such scaled point is calculated by the central controller 4230 for several preceding inhalation events. This is repeated for the second such point over the same inhalation event, and so on. Thus, for example, 65 scaled data points are generated by the central controller 4230, indicating the moving average of several preceding inhalation events (e.g., 3 events). Hereinafter in this specification, the moving average of the values of continuously updated (e.g., 65) points is referred to as the "scaled flow rate" and is denoted by Qs(t). Alternatively, a single inhalation event may be used instead of the moving average.

[0162] Two shape elements related to the determination of partial obstruction can be calculated from the scaled flow rate.

[0163] The shape factor 1 is the ratio of the average of the intermediate (e.g., 32) scaled flow points to the average of the overall (e.g., 65) scaled flow points. If this ratio exceeds 1, the respiration is considered normal. If this ratio is less than 1, the respiration is considered to have an obstruction. When the ratio is about 1.17, it is considered as the threshold between partial obstruction and non-obstructed respiration, equivalent to a certain level of obstruction that enables the maintenance of appropriate oxygen supplementation in typical patients.

[0164] The shape factor 2 is calculated as the mean square deviation from the unit-scaled flow over the intermediate (e.g., 32) points. When the mean square deviation is about 0.2 units, it is considered normal. When the mean square deviation is zero, the respiration is considered to be overall flow-restricted. The closer the mean square deviation approaches zero, the more the respiration is considered to be flow-restricted.

[0165] The shape factors 1 and 2 may be used alternatively or in combination. In other forms of the present technology, the number of sampled points, respiration, and intermediate points may be different from those described above. Furthermore, the threshold values may also be different from those described above. 4.4.2.2.5 Determination of apnea and hypopnea

[0166] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 for determining the presence of apnea and / or hypopnea.

[0167] In one form, the apnea / hypopnea detection algorithm 4325 receives the respiratory flow signal Qr as an input and provides a flag indicating whether apnea or hypopnea has been detected as an output.

[0168] In one form, apnea is detected when a function of the respiratory flow rate Qr falls below a flow threshold over a predetermined period. This function can determine peak flow, relatively short-term average flow, or a flow intermediate value of relatively short-term average and peak flow (e.g., RMS flow). The flow threshold can be a relatively long-term measurement of the flow rate.

[0169] In one form, hypopnea is detected when a function of the respiratory flow rate Qr falls below a second flow threshold over a predetermined period. This function can determine peak flow, relatively short-term average flow, or a flow intermediate value of relatively short-term average and peak flow (e.g., RMS flow). The second flow threshold can be a relatively long-term measurement of the flow rate. The second flow threshold is higher than the flow threshold used for apnea detection. 4.4.2.2.6 Determination of snoring

[0170] In one form of the present technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the snoring range.

[0171] In one form, the snoring detection algorithm 4326 receives the respiratory flow signal Qr as an input and provides measurements of the range where snoring exists as an output.

[0172] The snoring detection algorithm 4326 may include steps of determining the intensity of the flow signal within the range of 30 - 300 Hz. Further, the snoring determination algorithm 4326 may include steps of filtering the respiratory flow signal Qr to reduce background noise (e.g., airflow sounds in the system from a blower). 4.4.2.2.7 Determination of airway patency

[0173] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining the range of airway patency.

[0174] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as an input and determines the output of the signal within a frequency range of about 0.75 Hz to about 3 Hz. The presence of a peak within this frequency range is considered to indicate airway opening. The absence of a peak is considered an indication of airway closure.

[0175] In one form, the frequency range in which the peak is sought is the frequency range that is the frequency of a small forced oscillation at the therapeutic pressure Pt. In one embodiment, the forced oscillation is at a frequency of 2 Hz with an amplitude of about 1 cmH2O.

[0176] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as an input and determines the presence or absence of a cardiac-generated signal. The absence of a cardiac-generated signal is considered an indication of airway closure. 4.4.2.2.8 Determination of Target Ventilation

[0177] In one form of the present technology, the central controller 4230 takes the measurement of the current ventilation Vent as an input and executes one or more target ventilation determination algorithms 4328 for determining a target value Vtgt for the ventilation measurement.

[0178] In some forms of the present technology, the target ventilation determination algorithm 4328 does not exist and the target value Vtgt is predetermined and obtained, for example, by hard coding at the time of configuration of the RPT device 4000 or by manual input through the input device 4220.

[0179] In other forms of the present technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp indicative of the patient's typical recent ventilation.

[0180] In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a value that is high and less than the typical recent ventilation Vtyp. Such a high percentage in such forms can be within the ranges (80%, 100%), or (85%, 95%), or (87%, 92%).

[0181] In other forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a value that slightly exceeds a multiple of 1 of the typical recent ventilation Vtyp.

[0182] The typical recent ventilation Vtyp is a value around which the measurements of the current ventilation Vent are distributed over a plurality of time instants over some predetermined time scale and tend to cluster (i.e., a measure of the central tendency of the measurements of the current ventilation in the recent history). The target ventilation determination a In one embodiment of the target ventilation determination algorithm 4328, the recent history is on the order of a few minutes, but in any case must be longer than the time scale of the chain - Stokes increment and decrement cycles. The target ventilation determination algorithm 4328 can determine the typical recent ventilation Vtyp from the measurements of the current ventilation Vent using any of a variety of well - known measures of central tendency. One such measure is the low - pass filter output for the measurements of the current ventilation Vent, with a time constant equal to 100 seconds. 4.4.2.2.9 Determination of treatment parameters

[0183] In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 for the determination of one or more treatment parameters using values returned from one or more of the other algorithms in the treatment engine module 4320.

[0184] In one form of the present technology, the treatment parameter is the instantaneous treatment pressure Pt. In one embodiment of this form, the treatment parameter determination algorithm 4329 determines the treatment pressure Pt using the following equation. JPEG0007717234000002.jpg1060 (1)

[0185] Here: ● A is the amplitude, ● Π(Φ,t) is the waveform template value (in the range from 0 to 1) at the current value Φ of the phase and at time t, ● P0 is the base pressure.

[0186] If the waveform determination algorithm 4322 provides the waveform template Π(Φ) as a look-up table of values Π indexed by the phase Φ, the treatment parameter determination algorithm 4329 locates the nearest look-up table input for the current value Φ of the phase returned from the phase determination algorithm 4321 or otherwise between two inputs straddling the current value Φ of the phase and applies equation (1).

[0187] The values of the amplitude A and the base pressure P0 can be set by the treatment parameter determination algorithm 4329 according to the selected respiratory pressure treatment mode. 4.4.2.3 Treatment control module

[0188] The treatment control module 4330 according to one aspect of the present technology receives, as inputs, the treatment parameters from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 and controls the pressure generator so as to deliver an air flow from the pressure generator 4140 in accordance with these treatment parameters.

[0189] In one form of the present technology, the treatment parameter is the treatment pressure Pt, and the treatment control module 4330 controls the pressure generator so as to deliver an air flow from the pressure generator 4140 such that the interface pressure Pm at the patient interface 3000 or 3800 is equal to the treatment pressure Pt. 4.4.2.4 Detection of fault states

[0190] In one form of the technology, the central controller 4230 executes one or more methods 4340 for detecting a fault condition. The fault condition detected by the one or more methods 4340 may include at least one of the following: ● Power outage (no power or insufficient power) ● Detection of converter failure ● Failure to detect the presence of a component ● Operating parameters are outside the recommended range (e.g., pressure, flow rate, temperature, PaO2) ● Failure to perform a test warning for generating a detectable warning signal.

[0191] When a fault condition is detected, the corresponding algorithm 4340 signal signals the presence of the fault by one or more of the following: ● Initiation of audible, visual and / or kinetic (e.g., vibratory) warnings ● Sending a message to an external device ● Logging of incidents 4.5 Air circuit

[0192] An air circuit 4170 according to one aspect of the technology is a conduit or tube constructed and arranged such that an air flow moves between two components (e.g., the RPT device 4000 and the patient interface 3000 or 3800) during use. 4.6 Humidifier 4.6.1 Overview of the humidifier

[0193] In one form of the technology, a humidifier 5000 is provided for changing the absolute humidity of the air or gas to be delivered to the patient relative to the ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and the temperature of the air flow before delivery to the patient airway.

[0194] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. In some forms as shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240. 4.6.2 Humidifier Components 4.6.2.1 Heating Element

[0195] In some cases, the heating element 5240 may be provided to the humidifier 5000 that provides heat input to one or more of the water quantity in the humidifier reservoir 5110 and / or the water quantity to the air flow. The heating element 5240 may include a heat generating component such as an electric resistance heating track. One suitable example of the heating element 5240 is, for example, the layered heating element described in PCT Patent Application Publication No. WO2012 / ******. In this specification, the entire document is incorporated by reference for reference purposes.

[0196] In some forms, the heating element 5240 may be provided into the humidifier base 5006. In the humidifier base 5006, heat may be sent to the humidifier reservoir 5110 mainly by conduction as shown in FIG. 5B. 4.6.2.2 Humidifier Controller

[0197] According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250 as shown in FIG. 5C. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that can communicate with the central controller 4230.

[0198] In one form, the humidifier controller 5250 may receive, as input, measurements of characteristics (e.g., temperature, humidity, pressure, and / or flow rate) (e.g., air flow, water measurements in reservoir 5110 and / or in humidifier 5000). The humidifier controller 5250 may also be configured to execute or implement a humidifier algorithm and / or deliver one or more output signals.

[0199] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240). 4.7 Respiratory waveform

[0200] FIG. 6A shows a model of a typical respiratory waveform of a human during sleep. The horizontal axis is time and the vertical axis is respiratory flow rate. Since the parameter values can vary, a typical respiration may have the following approximate values: tidal volume, Vt, 0.5 L, inspiratory time, Ti, 1.6 s, peak inspiratory flow rate, Qpeak, 0.4 L / s, expiratory time, Te, 2.4 s, peak expiratory flow rate, Qpeak, -0.5 L / s. The total duration of respiration Ttot is about 4 s. A human typically breathes about 15 times per minute (BPM), and the ventilation Vent is about 7.5 L / min. The ratio of a typical duty cycle, Ti to Ttot, is about 40%. 4.8 Screening, diagnosis, monitoring system 4.8.1 Sleep polysomnogram

[0201] Figure 7A shows a patient 1000 undergoing a polysomnogram (PSG). The PSG system includes a headbox 2000. The headbox 2000 receives and records signals from the following sensors: EOG electrodes 2015, EEG electrodes 2020, ECG electrodes 2025, submental EMG electrodes 2030, snoring sensor 2035, respiratory inductance plethysmogram (respiratory effort sensor) 2040 on a chest belt, respiratory inductance plethysmogram (respiratory effort sensor) 2045 on an abdominal belt, a nasal cannula 2050 with an oral thermistor, a photoplethysmogram (pulse oximeter) 2055, and a body position sensor 2060. The electrical signals are referred to as a ground electrode (ISOG) 2010 positioned at the center of the forehead. 4.8.2 Non-Obstructive Monitoring System

[0202] An example of a monitoring device 7100 for monitoring the respiration of a patient 1000 during sleep is shown in Figure 7B. The monitoring device 7100 includes a non-contact motion sensor mainly directed towards the patient 1000. This motion sensor is configured to generate one or more signals indicating the movement of the body of the patient 1000. From these signals, a signal indicating the respiratory movement of the patient can be obtained. 4.8.3 Respiratory Polygraphy

[0203] Respiratory polygraphy (RPG) is a term referring to a simple form of PSG and does not use electrical signals (EOG, EEG, EMG), snoring, or body position sensors. RPG includes at least the following: a chest movement signal from a respiratory inductance plethysmogram (motion sensor) on a chest band (e.g., motion sensor 2040), a nasal pressure signal sensed via a nasal cannula, and an oxygen saturation signal from a pulse oximeter (e.g., pulse oximeter 2055). These three RPG signals or channels are received by an RPG headbox similar to the PSG headbox 2000.

[0204] In a particular configuration, the nasal pressure signal is an excellent proxy for the nasal flow signal generated by a flow transducer that is hardwired to a sealed nasal mask because the shape of the nasal pressure signal is similar to that of the nasal flow signal. As a result, when the patient's mouth remains closed (i.e., there is no leakage from the mouth), the nasal flow is equal to the respiratory flow. 4.9 Respiratory Therapy Modes

[0205] A variety of respiratory therapy modes can be implemented by the RPT device 4000. 4.9.1 CPAP Therapy

[0206] In some implementations of respiratory pressure therapy, the central controller 4230 sets the therapy pressure Pt as part of a therapy parameter determination algorithm 4329 according to the therapy pressure equation (1). In some such embodiments, since the amplitude A is equally zero, the therapy pressure Pt (which represents the target value achieved by the interface pressure Pm at the current instant in time) is likewise equal to the base pressure P0 throughout the respiratory cycle. Such embodiments are mainly grouped under the heading of CPAP therapy. In such embodiments, a therapy engine module 4320 for determining the phase Φ or the waveform template Π(Φ) is not required.

[0207] In CPAP therapy, the base pressure P0 can be a constant value, either hard-coded or manually input into the RPT device 4000. The central controller 4230 can repeatedly calculate the base pressure P0 as a function of an indicator or measurement of sleep disordered breathing (e.g., one or more of flow limitation, apnea, hypopnea, patency, and snoring) returned from each algorithm in the therapy engine module 4320. This alternative is also referred to as APAP therapy.

[0208] Figure 4E is a flowchart showing a method 4500 executed by a central controller 4230. In method 4500, when the pressure support A is equal to zero, the base pressure P0 is continuously calculated as part of the execution of the APAP treatment of the treatment parameter determination algorithm 4329.

[0209] Method 4500 starts from step 4520. In step 4520, the central controller 4230 compares the measurement of the presence of apnea / hypopnea with a first threshold, and determines whether the measurement of the presence of apnea / hypopnea exceeds the first threshold over a pre-determined period (which indicates the occurrence of apnea / hypopnea). If the measurement of the presence of apnea / hypopnea exceeds the first threshold over a pre-determined period, method 4500 proceeds to step 4540; if the measurement of the presence of apnea / hypopnea does not exceed the first threshold over a pre-determined period, method 4500 proceeds to step 4530. In step 4540, the central controller 4230 compares the measurement of airway patency with a second threshold. If the measurement of airway patency exceeds the second threshold, it indicates that the airway is open and the detected apnea / hypopnea is considered to be central, and method 4500 proceeds to step 4560. If the measurement of airway patency does not exceed the second threshold, the apnea / hypopnea is considered to be obstructive, and method 4500 proceeds to step 4550.

[0210] In step 4530, the central controller 4230 compares the measurement of flow limitation with a third threshold. If the measurement of flow limitation exceeds the third threshold, it indicates that the inspiratory flow is restricted. In that case, method 4500 proceeds to step 4550. If the measurement of flow limitation does not exceed the third threshold, method 4500 proceeds to step 4560.

[0211] In step 4550, if the obtained treatment pressure Pt does not exceed the maximum treatment pressure Pmax, the central controller 4230 increases the base pressure P0 by a pre-determined pressure increment ΔP. In one implementation, the pre-determined pressure increment ΔP and the maximum treatment pressure Pmax are 1 cmH2O and 25 cmH2O respectively. In other implementations, the pressure increment ΔP can be as low as 0.1 cmH2O and as high as 3 cmH2O, or as low as 0.5 cmH2O and as high as 2 cmH2O. In other implementations, the maximum treatment pressure Pmax can be as low as 15 cmH2O and as high as 35 cmH2O, or as low as 20 cmH2O and as high as 30 cmH2O. Next, the method 4500 returns to step 4520. In other implementations, the pressure increment ΔP can be as low as 0.1 cmH2O and as high as 3 cmH2O, or as low as 0.5 cmH2O and as high as 2 cmH2O. In other implementations, the maximum treatment pressure Pmax can be as low as 15 cmH2O and as high as 35 cmH2O, or as low as 20 cmH2O and as high as 30 cmH2O. Next, the method 4500 returns to step 4520.

[0212] In step 4560, if the decreased base pressure P0 does not fall below the minimum treatment pressure Pmin, the central controller 4230 decreases the base pressure P0 by a decrement. Next, the method 4500 returns to step 4520. In one implementation, since the decrement is proportional to the value of P0 - Pmin, in the absence of detected events, the decrease of P0 to the minimum treatment pressure Pmin is exponential. In one implementation, the constant of the proportional relationship is set such that the time constant τ of the exponential decrease of P0 is 60 minutes and the minimum treatment pressure Pmin is 4 cmH2O. In other implementations, the time constant τ can be as short as 1 minute and as long as 300 minutes, or as short as 5 minutes and as long as 180 minutes. In other implementations, the minimum treatment pressure Pmin can be as low as 0 cmH2O and as high as 8 cmH2O, or as low as 2 cmH2O and as high as 6 cmH2O. Alternatively, the decrement of P0 may be pre-determined such that the decrease of P0 to the minimum treatment pressure Pmin is linear in the absence of detected events. 4.9.2 Bilevel Therapy

[0213] In other embodiments of this form of the technology, the value of the amplitude A in equation (1) can be positive. Such an implementation is known as bilevel therapy. This is because when the therapeutic pressure Pt is determined using equation (1) with a positive amplitude A, the treatment parameter determination algorithm 4329 oscillates the therapeutic pressure Pt between two values or levels in synchronization with the patient 1000's spontaneous breathing effort. That is, based on the typical waveform template Π(Φ,t) described above, the treatment parameter determination algorithm 4329 increases the therapeutic pressure Pt to P0+A (known as IPAP) at the start or during inspiration, and decreases the therapeutic pressure Pt to the base pressure P0 (known as EPAP) at the start or during expiration.

[0214] In some forms of bilevel therapy, IPAP is the therapeutic pressure for the same purpose as the therapeutic pressure in the CPAP treatment mode, and EPAP is the value obtained by subtracting the amplitude A from IPAP and has a "small" value (a few cmH2O), also called expiratory pressure relief (EPR). Such a form is also called CPAP treatment using EPR and is generally considered to be more comfortable than direct CPAP treatment. In the case of CPAP treatment using EPR, either or both of IPAP and EPAP can be constant values, either hard-coded or manually input into the RPT device 4000. Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate IPAP and / or EPAP during CPAP using EPR. In this alternative, the treatment parameter determination algorithm 4329 repeatedly calculates EPAP and / or IPAP as a function of the indices or measurements of sleep disordered breathing returned from each algorithm in the treatment engine module 4320. This is done in the same way as the calculation of the base pressure P0 in the APAP treatment described above.

[0215] In other forms of bilevel therapy, the amplitude A is large enough that the RPT device 4000 performs some or all of the patient 1000's respiratory movements. In such forms known as pressure-assisted ventilation therapy, the amplitude A is referred to as pressure assistance or swing. In pressure-assisted ventilation therapy, IPAP is the base pressure P0 + the pressure assistance A, and EPAP is the base pressure P0.

[0216] In some forms of pressure-assisted ventilation therapy known as constant pressure-assisted ventilation therapy, the pressure assistance A is fixed at a predetermined value (e.g., 10 cmH2O). The predetermined pressure assistance value is a setting of the R PT device 4000 and can be hard-coded, for example, at the time of configuring the RPT device 4000 or set by manual input through the input device 4220.

[0217] In other forms of pressure-assisted ventilation therapy widely known as servo ventilation, the treatment parameter determination algorithm 4329 takes as inputs a certain currently measured or estimated parameter of the respiratory cycle (e.g., the currently measured Vent of ventilation) and a target value of the respiratory parameter (e.g., the target value Vtgt of ventilation), and continuously adjusts the parameters of Equation (1) to bring the current measurement of the respiratory parameter closer to the target value. In the form of servo-ventilation known as adaptive servo ventilation (ASV) used in CSR therapy, the respiratory parameter is ventilation, and the target ventilation value Vtgt is calculated by the target ventilation determination algorithm 4328 from the typical recent ventilation Vtyp as described above.

[0218] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control method that repeatedly calculates the pressure assistance A so that the current measurement of the respiratory parameter reaches the target value. One such control method is proportional-integral (PI) control. In one embodiment of PI control suitable for the ASV mode set such that the target ventilation Vtgt is slightly lower than the typical recent ventilation Vtyp, the pressure assistance A is repeatedly calculated as follows: JPEG0007717234000003.jpg1478 (2)

[0219] Here, G is the gain of the PI control. When the value of the gain G increases, the feedback in the treatment engine module 4320 can become positive. When the value of the gain G decreases, a certain remaining untreated CSR or central sleep apnea may occur. In some embodiments, the gain G is fixed at a predetermined value (for example, -0.4 cmH2O / (L / min) / sec). Alternatively, the gain G can be changed between treatment sessions until a value substantially free of CSR is reached (starting from a low value initially and increasing between sessions). Conventional means for retrospectively analyzing the parameters of a treatment session to evaluate the severity of CSR during the treatment session can be used in such embodiments. In yet other embodiments, the gain G can vary according to the difference between the current measurement of ventilation Vent and the target ventilation Vtgt.

[0220] Other servo ventilation control methods that can be applied by the treatment parameter determination algorithm 4329 include proportional (P), proportional derivative (PD), and proportional integral derivative (PID).

[0221] The value of the pressure assist A calculated via equation (2) can be clipped to the range defined as [Amin, Amax]. In this embodiment, the pressure assist A is set as default at the minimum pressure assist Amin until the measurement of the current ventilation Vent is below the target ventilation Vtgt. When the measurement of the current ventilation Vent falls below the target ventilation Vtgt, A begins to increase and decreases back to Amin only when Vent exceeds Vtgt again.

[0222] The pressure assist limits Amin and Amax are settings of the RPT device 4000 and are, for example, hard-coded during the configuration of the RPT device 4000 or set by manual input through the input device 4220.

[0223] In the pressure-assisted ventilation treatment mode, EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP treatment, EPAP can be a constant value and is specified or determined during titration. Such a constant EPAP can be set, for example, by hard-coding during the configuration of the RPT device 4000 or by manual input through the input device 4220. This alternative is also called fixed EPAP pressure-assisted ventilation treatment. The titration of EPAP for a given patient can be performed by a clinician during a titration session using PSG for the purpose of preventing obstructive apnea, whereby airway patency is maintained for pressure-assisted ventilation treatment in a manner similar to the titration of the base pressure P0 in constant CPAP treatment.

[0224] Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate the base pressure P0 during pressure-assisted ventilation treatment. In such an embodiment, the treatment parameter determination algorithm 4329 repeatedly calculates EPAP as a function of the indices or measurements of sleep disordered breathing (e.g., one or more of flow limitation, apnea, hypopnea, patency, and snoring) returned from each algorithm in the treatment engine module 4320. Since the continuous calculation of EPAP is similar to the manual adjustment of EPAP by a clinician during the titration of EPAP, this process is also called automatic titration of EPAP, and the treatment mode is known as automatic titration EPAP pressure-assisted ventilation treatment or automatic EPAP pressure-assisted ventilation treatment. 4.9.3 High-flow treatment

[0225] In other forms of respiratory therapy, the pressure of the airflow is not controlled as it is used for respiratory pressure therapy. That is, the central controller 4230 controls the pressure generator 4140 to deliver an airflow (where the device flow Qd is controlled to be the therapeutic or target flow Qtgt). Such forms are primarily grouped under the heading of flow therapy. In flow therapy, the therapeutic flow Qtgt may be a constant value, hard-coded or manually entered into the RPT device 4000. When the therapeutic flow Qtgt is sufficient to exceed the patient's peak inspiratory flow, the therapy is primarily referred to as high flow therapy (HFT). Alternatively, the therapeutic flow may be a profile Qtgt(t) that varies over the respiratory cycle. 4.10 Data Transmission

[0226] FIG. 8 shows a block diagram illustrating one implementation of an RPT system according to the present technology. The RPT system includes an RPT device 4000 configured to provide respiratory pressure therapy to a patient 1000, a data server 7100, and a patient computing device 7050 associated with the patient 1000. The patient computing device 7050 may be co-located with the patient 1000 and the RPT device 4000. In the implementation shown in FIG. 8, the RPT device 4000, the patient computing device 7050, and the data server 7100 are connected to a wide area network 7090 (e.g., the Internet, an intranet, the cloud, or the Internet). The connection to the network may be wired or wireless. The network may be identified with the remote external communications network 4282 in FIG. 4C, and the data server 7100 may be identified with the remote external device 4286 in FIG. 4C. The patient computing device 7050 may be a personal computer, a mobile phone, a tablet computer, or other device. The patient computing device 7050 is configured to interface between the patient 1000 and the data server 7100 over a wide area network 7090. In one implementation, this intermediation is performed by a software application program 7060 executing on the patient computing device 7050. The patient program 7060 may be a dedicated application called a "patient application" that interacts with a complementary process hosted by the data server 7100. In another implementation, the patient program 7060 is a web browser that interacts with a secure portal through a website hosted by the data server 7100. In yet another implementation, the patient program 7060 060 is an email client.

[0227] In other examples, the RPT device 4000 communicates with the patient computing device 7050 via a local (wired or wireless) communication protocol (e.g., a local network protocol (e.g., Bluetooth®)). In an alternative implementation, the local network can be identified with the local external communication network 4284 of FIG. 4C, and the patient computing device 7050 can be identified with the local external device 4288 of FIG. 4C. In an alternative implementation, the patient computing device 7050 is configured via the patient program 7060 to mediate between the patient 1000 and the data server 7100 via the network 7090 and to mediate between the RPT device 4000 and the data server 7100 via the network 7090.

[0228] The RPT system may include other RPT devices (not shown) associated with each patient having an associated computing device as well. Further, the RPT system 7000 may include other monitoring or treatment devices that can interface with the controller 4230 or the patient computing device 7050. All patients of the RPT system 7000 are managed by the data server 7100.

[0229] The RPT device 4000 is configured to store in the memory 4260 the treatment data delivered to the patient 1000 from each RPT session. The treatment data regarding an RPT session includes the settings of the RPT device 4000 and treatment variable data indicating one or more variables of the respiratory pressure treatment throughout the RPT session.

[0230] The data server 7100 can also be configured to receive data from the patient computing device 7050. Such can include data input by the patient 1000 into the patient program 7060 or treatment / usage data in the alternative implementation 7000B described above.

[0231] The data server 7100 is also configured to send electronic messages to the patient computing device 7050. These messages may take the form of detailed emails, SMS messages, automated voice messages or notifications within the patient program 7060.

[0232] The RPT device 4000 may be configured to be alerted about its therapy mode or settings for a particular therapy mode when a corresponding command is received over its wide area network connection or local area network connection. In such an implementation, the data server 7100 may be configured to send such commands directly to the RPT device 4000 (in implementation 7000) or indirectly to the RPT device 4000 for relay via the patient computing device 7050 (in implementation 7000B).

[0233] The server 7100 and database 7200 may be a single server and database combination or may include multiple combinations of servers 7100 and databases 7200 at different locations. For example, the RPT device 4000 may be connected to one or more server 7100 and database 7200 combinations that store and communicate various data features (e.g., treatment settings or parameters) and other data over the network 7090.

[0234] For example, a system may include a general patient system 8100 and a prescription system 8200, each of which includes a combination of a server 7100 and a database 7200. In the database 7200, prescription system 8200 may store prescriptions for patient 1000 referenced to a unique identifier for patient 1000. The prescription data stored in database 7200 may include data indicating prescribed pressure levels (e.g., minimum and maximum pressures), treatment modes, and other respiratory treatment parameters.

[0235] In some instances, additional data and preference information related to a patient's treatment (excluding the patient's defined treatment parameters) may be stored on the general patient system 8100 (rather than the prescription system 8200) on the associated database 7200. For example, all of the profile data, other preference information, account information, etc. of patient 1000 may be stored on a separate database 7200. A reason this can be advantageous is that if any database 8200 and system contains data indicating a physician's defined treatment parameters, compliance with privacy laws and / or certain statutes may be required. Thus, by storing non-defined settings on the general patient system 8100, it may not be necessary to comply with as many statutes. In other instances, both prescription-related parameters and non-prescription-related parameters are stored on the same server 7100 and database 7200. Treatment settings

[0236] Generally, the treatment settings stored on the database 7200 may include data indicating a treatment pressure Pt. The treatment pressure Pt may be implemented by a controller 4230 that sets the pressure using different treatment parameter determination algorithms 4329. In some cases, the treatment pressure may include a minimum and a maximum pressure. These treatment settings may also include a constant pressure for CPA, or alternatively, the treatment system may enable the calculation of a base pressure based on the treatment pressure and various indices as described above in APAP treatment.

[0237] These treatment settings may include various modes (e.g., CPAP, APAP, bilevel treatment, high-flow treatment). Further, the treatment settings may include humidification or temperature settings and other features or characteristics of the respiratory treatment that can be controlled or manipulated.

[0238] These treatment settings can be stored in a database 7200 that is referenced for patient 1000 (e.g., through a unique identifier), and can also reference the type and / or model number of the respiratory treatment device 4000 for which the treatment settings are valid. In some examples, the prescription settings, including treatment pressure, can be referenced against: (1) the date of the prescription, (2) the prescribing physician, (3) the prescribed treatment mode, (4) the prescribed type, model, and serial number of the respiratory treatment device 4000, and (5) other information. 4.11 Transfer of Treatment Settings

[0239] One form of the technology includes a method and system for automatically porting respiratory treatment settings to a new respiratory treatment device 4000. Currently, when patient 1000 receives a replacement respiratory treatment device 4000, an upgraded respiratory treatment device 4000, or an additional / new type of respiratory treatment device 4000, it is necessary to manually port the prescription settings through human intervention. For example, for patient 1000 to obtain a new RPT device 4000 while already having an existing device and prescription (REPAP), patient 1000 needs to order the new device from a provider, and the provider needs to either manually install the settings onto the RPT device 4000 or the provider may manually update its database 7200 through server 7100 to add the new RPT device 4000. This operation includes adding the model number of the new RPT device 4000, the network address, and the prescription treatment settings corresponding to the RPT device 4000. Therefore, patient 1000 does not face difficulties or a long installation process when ordering a new device from the current provider.

[0240] Therefore, the inventors have developed a new technique for automatically porting respiratory therapy settings to new RPT devices 4000. This is highly advantageous because it provides the opportunity to purchase RPT devices 4000 from any vendor without pre-installed prescription therapy settings or units pre-registered with the provider's server 7100 and database 7200. This allows for automation of ordering and installation of new RPT devices 4000, reducing the need for human intervention.

[0241] Additionally, the inventors have developed several features for the implementation of this technology, including: (1) Converting a treatment setting to a different make or model of RPT Device 4000 (2) the process for determining whether a prescription is valid; (3) the process for determining whether a prescription is valid; (4) A process for validating the patient's 1000 identification information and determining whether the patient 1000 has an existing RPT device 4000 . (5) a process for validating data for other patients 1000 and identifying changes in data for patients 1000 that may require new prescriptions; (6) monitoring the treatment quality indicators of the RPT device 4000 after porting of the treatment setting to determine whether the prescription is appropriate for the new RPT device 4000; and (7) Other things. These novel features are described in several examples herein, and various combinations of these features may be employed in the present technology.

[0242] FIG. 9 is a flowchart of one way to transfer a treatment setting to a new RPT device 4000. First, the system may receive a request 9000 to port a treatment setting to the new RPT device 4000. This may be done through the patient computing device 7050, through the interface 4229 on the new RPT device 4000, or through another computing device. In some examples, the new RPT device 4000 is locked until a new setting (such as a key to unlock the device for use) is received from the cloud. This allows the device to be shipped to the patient without already set settings based on the patient's prescription. Additionally, different labeling or legal regulations for future specific products may be made possible.

[0243] In some examples, the patient 1000 may log in to an account on their patient computing device 7050 using a unique user ID and password 9100 and may indicate through the interface a desire to port settings since a further RPT device 4000 has been received. In other examples, when the patient 1000 powers on the new RPT device 4000, the new device may request account information or may otherwise initiate the process of porting treatment settings.

[0244] In some examples, the patient computing device 7050 or other computing device may request the serial number of the replacement RPT device 9200. In other examples, the computing device may send a request for the serial number of an existing RPT device 9200 to confirm that patient 1000 owns the device. In other examples, an existing RPT device 4000 may display a new and unique code on the display 4294. This new and unique code is a code that patient 1000 needs to enter into the patient computing device 7050 or other computing device to confirm that patient 1000 currently owns the existing RPT device 4000 associated with their account.

[0245] In one example, one of the server 7100 and the database 7200 may check the information including the serial number or code to determine whether it matches the information associated with the patient ID stored in the database 7200.

[0246] The server 7100 then transmits the prescribed treatment settings to the RPT device 4000 if the information is valid (9300), and the prescribed treatment settings are saved in the memory of the new RPT device 4000. Various methods can be used to transfer the settings to the new RPT device 4000 (e.g., porting the settings via a Bluetooth® connection 9450 between the patient computing device 7050 and the new RPT device 4000). In this example, if a patient account is logged in on the patient computing device 7050, the patient computing device 7050 can establish a connection to the new RPT device 4000 via Bluetooth®. In other examples, the setting data can be transmitted via a cellular network to the cellular antenna 9460 of the RPT device 4000 or can be transmitted to the new RPT device 4000 via a Wi-Fi connection 9470. In some examples, these settings are sent in encrypted form from the server 7100 to the RPT device 4000 (using the patient computing device 7050 as a conduit via Bluetooth). In this example, the patient computing device 7050 is not able to decrypt or store these settings, so these settings are sent in encrypted form from at least one of the servers 7100 to the new RPT device 4000. Treatment Configuration Porting Conversion and Activation Processes

[0247] Figure 10 shows a block diagram illustrating an embodiment of an RPT system according to the present technology. In this example, the technology includes programs for a prescription setting converter 10020 and a portability check 10030. These programs are resident in one of a combination of a database 7200 and a server 7100 or are resident in an RPT device 4000 or a patient computing device 7050. The program for the check 10030 and the program for the converter 10020 are used for processing prescription treatment settings 10060 and any other general patient data 10050, preference information, or other information that needs to be ported to the new RPT device 4000.

[0248] Figure 11 shows an exemplary method of performing the conversion and check. For example, in some examples, referring to Figure 9, after the serial number and account ID are enabled (9100 and 9200), in the present technology, after performing the check and conversion, the treatment settings 11400 are paired. Enabling process for porting treatment settings

[0249] The system may perform the following process for the check 11400 or enabling process. If any of these end in failure, the patient 1000 may be flagged for follow-up and the settings are not ported (11400): (1) A valid prescription; (2) The date of the prescription; (3) Changes in patient data; (4) Treatment quality indicators; (5) Oximeter readings 11460; and (6) Others. For example, before transmitting prescription treatment settings, comfort settings, or other settings by the server 7100, the present technology may check various data (e.g., data output from the RPT device 4000) to confirm whether the treatment settings should be ported. If the server 7100 determines that any of these checks fail, the server 7100 will use a new RPT device For 4000 or patient computing device 7050, send a response indicating that the port for the treatment setting is not available and that patient 1000 is flagged as a follow-up target so that the patient can receive an updated prescription.

[0250] For example, by checking the date associated with the current prescription treatment setting (e.g., the timestamp of the date when the prescription was entered, written, or received in database 7200) against the current date, it may be possible to confirm that the time threshold has not elapsed (e.g., 1 year, 2 years, 5 years, etc. since the initial input or prescription of the prescription). This avoids situations where patient 1000 continues to use an expired prescription or situations where there is a risk of rejection or delay from the insurance provider or payer due to the expiration of the prescription for the patient.

[0251] Furthermore, patient data change 11480 can be evaluated to determine if there are any significant changes associated with the prescription change in patient 1000. For example, the system can perform an age check on patient 1000 based on the patient's profile data and determine if patient 1000 has reached any milestones (where an update to the treatment setting is generally required due to physiological changes associated with aging). This can be checked by examining the date of birth on patient 1000's profile data 10050 stored on general patient system 8100 and comparing it to the current date.

[0252] Furthermore, patient data change 11480 can be information or data obtained by sending a questionnaire to the patient interface (on any of the various computing devices or RPT device inputs 4220) when the port for the setting is initiated. For example, the questionnaire can be used to ask patient 1000 questions to evaluate the following: (1) Weight; (2) BMI; (3) Subjective sleep quality; (4) Changes in the mattress or other sleep environment; (5) Relocation; and (6) Other information. For example, if it is determined that the weight or BMI of patient 1000 has changed relative to a threshold amount, the pressure assessment may need to be performed based on a known threshold change in BMI or the position of patient 1000 that requires a change in the new pressure or other treatment parameters in the weight or BMI curve (when gender, race, etc. are known). Additionally, inquiries may be made about other factors that can affect the settings.

[0253] In some examples, these elements can be automatically evaluated using various imaging or other data processing techniques for the estimation of relevant characteristics of patient 1000. For example, an image of patient 1000 can be processed by a self - imaging tool and compared to the previous image of patient 1000 to determine whether the change in the image indicates a change in BMI. This can include methods for determining the relative dimensional shape of patient 1000 (e.g., measuring the diameter of an eye feature (that does not change over time) such as the pupil or iris). Additionally, the relative size can also be determined using the measurement of eye features by the self - imaging tool (e.g., scale compensation based on the difference between images in the distance from the face to the camera).

[0254] In some examples, in the case of a self - imaging tool, patient 1000 may need to bring the camera closer to patient 1000's face until it is determined by the eye measurement (or other common feature) that patient 1000 is holding the camera at an acceptable distance, a predetermined distance, or the same distance as the previous image. In some examples, the camera may include depth - sensor technology, which can improve the estimation of changes in the patient's face related to treatment changes.

[0255] In some examples, in the present technology, first, a treatment quality indicator can be checked, and then a treatment setting can be ported. For example, if the treatment quality indicator is below an acceptable threshold or indicates that there is a problem with the treatment of patient 1000, according to the present technology, the porting of setting 11500 can be rejected, and the patient can be flagged for follow-up. The treatment quality indicator can include: (1) Output of usage data from the RPT device 4000 - The usage pattern can indicate the prescription of patient 1000 or other settings that have caused interruption or minimization of use of patient 1000; (2) Treatment quality index; (3) Hypopnea events; (4) Other sleep disturbances; (5) Sleep score; (6) Data output from a pulse oximeter; and (7) Others.

[0256] In some examples, according to the present technology, questions can be presented to patient 1000 to determine or evaluate whether patient 1000 can switch to a new RPT device 4000 without a physician's evaluation and prescription. For example, if patient 1000 wants to switch from a full mask to a nasal-only mask, according to the present technology, a request such as take a photo for evaluation of the nasal area or process the voice data of patient 1000 during sleep may be made to determine whether the patient is breathing through the mouth or the nose. In these cases, according to the present technology, if there is any problem, the porting of setting 11500 can be automatically rejected.

[0257] Furthermore, according to the present technology, the same treatment quality indicator can be further checked over a specific period after the start of use of the new RPT device 4000, and the initial check of the quality of patient 1000 can be performed using the same parameters on the replacement RPT device 4000. This can include time windows of one day, two days, one week, one month, or other suitable periods. Thus, in the present technology, the baseline level of respiratory treatment quality or the amount of threshold decrease in respiratory treatment quality can be checked in comparison to the respiratory treatment quality of the current respiratory treatment device 4000. Setting converter

[0258] In addition to flagging problems prior to porting of treatment settings, in the present technology, conversion, calibration, or adjustment of settings of a new unit, model, or type of respiratory treatment device 4000 can also be performed. The prescription setting converter 10020 can include various features for performing mapping, conversion, calibration, or other forms of adaptation from the current RPT device 4000 to the new device 4000.

[0259] For example, the database 7200 can include mappings between models, types, and units of the RPT device 4000. For example, the treatment pressure can be slightly adjusted to compensate for the pressure difference between specific units. This can include listings and mappings to a database spreadsheet or other ontologies for mapping multiple units, and equations for converting pressure or other modes and settings into forms for the new device.

[0260] Furthermore, adjustment of non-prescription settings, modes, and other features can be performed based on the known calibration amounts between devices. For example, in the case where, for example, the pressure of a specific model is slightly higher or it is known that the patient responds better to a lower pressure, in the automatic ramp-up algorithm the intensity of the RAMP feature or the rate of increase and / or decrease of pressure can be changed between devices of different model types.

[0261] In some examples, according to the present technology, non-prescription features and the like can be learned over time between units based on the adjustment of these features after patient use. Thus, according to the present technology, it may be possible to predict the mapping between units for a particular type of patient based on patient data and context. 4.12 Glossary

[0262] For the purposes of disclosing the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may also apply. 4.12.1 General

[0263] Air: In certain forms of the present technology, air may mean the atmosphere, and in other forms of the present technology, air may mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0264] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) outside the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

[0265] For example, the atmospheric humidity for a humidifier can be the humidity of the air directly surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such atmospheric humidity may be different from the humidity outside the room where the patient is sleeping.

[0266] In another example, the atmospheric pressure can be the pressure directly surrounding or outside the body.

[0267] In certain forms, the atmospheric (e.g., acoustic) noise can be considered the background noise level in the room where the patient is located, for example, other than the noise generated from the RPT device or from the mask or patient interface. The atmospheric noise can be generated from a source outside the room.

[0268] Automated Positive Airway Pressure (APAP) Therapy: A form of CPAP therapy that can automatically adjust the therapeutic pressure between a minimum and a maximum limit, for example, in response to the presence or absence of signs of SDB during the breathing cycle.

[0269] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the therapeutic pressure remains substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different breathing cycles of the patient (e.g., increases in response to detection of signs of partial upper airway obstruction and decreases in the absence of notification of partial upper airway obstruction).

[0270] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to the instantaneous amount. In some cases, when referring to flow rate, it refers to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to flow rate, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may be abbreviated as "flow" or "airflow" in some cases.

[0271] In an example of a patient's breathing, the flow rate can be nominally positive pressure with respect to the inhalation portion of the patient's breathing cycle and thus negative with respect to the exhalation portion of the patient's breathing cycle. The devi The device flow rate Qd is the flow rate of air exiting the RPT device. The total flow rate Qt is the flow rate of air reaching the patient interface via the air circuit and any supplemental gas. The ventilation flow rate Qv is the flow rate of air exiting the ventilation section to allow the outflow of the exhaled gas. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The respiratory flow rate Qr is the flow rate of air received in the patient's respiratory system.

[0272] Humidifier: The term "humidifier" is construed to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor into an air stream to improve a patient's medical breathing condition.

[0273] Leakage: The term "leakage" is taken as an unintended air flow. In one embodiment, leakage may occur due to an incomplete seal between the mask and the patient's face. In another embodiment, leakage may occur at the ambient elbow.

[0274] Noise Conduction (Acoustic): As used herein, conductive noise refers to noise conveyed to the patient by a pneumatic path (e.g., an air circuit and the patient interface and the air within it). In one form, conductive noise may be quantified by measuring the sound pressure level at the end of the air circuit.

[0275] Noise Radiation (Acoustic): As used herein, radiated noise refers to noise conveyed to the patient by the ambient air. In one form, radiated noise may be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO3744.

[0276] Noise Ventilation (Acoustic): As used herein, ventilation noise refers to noise generated by an air flow through any ventilation (e.g., ventilation holes in the patient interface).

[0277] Patient: A person with or without a respiratory disease.

[0278] Pressure: Force per unit area. Pressure may be expressed in various units (e.g., cmH2O, g-f / cm 2 , and hectopascal). 1 cmH2O is equal to 1 g-f / cm 2 and approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m 2is from 1 millibar to 0.001 atm). In this specification, unless otherwise specified, pressure is given in units of cmH2O.

[0279] The pressure in the patient interface is denoted by the symbol Pm, and the treatment pressure, which represents the target value to be achieved by the interface pressure Pm at the current time, is denoted by the symbol Pt.

[0280] Respiratory pressure therapy (RPT): Addition of an air supply to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0281] Ventilator: A mechanical device that provides pressure assistance when a patient performs some or all of the breathing movements. 4.12.1.1 Materials

[0282] Silicone or silicone elastomer: A synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this registered trademark). Another LSR manufacturer is Wacker.

[0283] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate. 4.12.2 Respiratory cycle

[0284] Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, for example, 10 seconds. Obstructive apnea is said to occur when, despite the patient's effort, air flow is not permitted due to some airway obstruction. Central apnea refers to a state in which apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to a state in which a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0285] Respiratory rate: The spontaneous respiratory rate of the patient, usually measured as the number of breaths per minute.

[0286] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0287] Work (respiration): Respiratory effort is said to refer to the movement performed by the spontaneous respiration of a person attempting to breathe.

[0288] Expiratory part of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0289] Flow limitation: Flow limitation is interpreted as a situation in the patient's respiration where an increase in the patient's work does not cause a corresponding increase in the flow. When flow limitation occurs in the inspiratory part of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. When flow restriction occurs in the expiratory part of the respiratory cycle, the flow restriction can be referred to as expiratory flow limitation.

[0290] Types of waveforms of flow-limited inspiration: (i) Flattening: After rising, a relatively flat part follows, and then a decline occurs. (ii) M-shaped: It has two local peaks, one at the rise and one at the fall, and there is a relatively flat part between these two peaks. (iii) Chair-shaped: It has a single local peak that occurs in the rising part, followed by a relatively flat part. (iv) Inverse chair-shaped: A single local peak follows a relatively flat part, and this peak occurs in the falling part.

[0291] Hypopnea: According to some definitions, hypopnea means a decrease in flow rather than an interruption of flow. In one form, hypopnea is said to have occurred when a decrease in flow below a threshold velocity persists over a duration. When hypopnea is detected due to a decrease in respiratory effort, it is said that central hypopnea has occurred. In one form in adults, any of the following may be considered hypopnea: (i) A decrease of 30% in patient breathing for at least 10 seconds + associated 4% desaturation, or, (ii) A decrease (less than 50%) in patient breathing that persists for at least 10 seconds, with associated desaturation of at least 3% or arousal occurring.

[0292] Hyperventilation: An increase in flow to a level higher than normal flow.

[0293] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0294] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Quantification of airway patency can be done, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction ).

[0295] Positive end-expiratory pressure (PEEP): A pressure above atmospheric pressure in the lungs that exists at the end of expiration.

[0296] Peak flow (Qpeak): The maximum flow value in the inspiratory portion of the respiratory flow waveform.

[0297] Respiratory gas flow, air flow, patient air flow, respiratory gas air flow (Qr): These terms can be understood to refer to the estimation of the respiratory air flow of an RPT device and are used in contrast to the "true respiratory flow" or "true respiratory gas flow", which is the actual respiratory flow of the patient, usually expressed in liters per minute.

[0298] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume Vi (volume of air inhaled) is equal to the exhaled volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inhaled volume Vi and the exhaled volume Ve).

[0299] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0300] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0301] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0302] Typical Recent Ventilation: The ventilation value around which recent values of ventilationVent over a given time scale tend to cluster (i.e., the degree to which recent values of ventilation tend to be centered).

[0303] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).

[0304] Vent: A measure of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inspiratory and expiratory flow per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood as volume per minute. 4.12.3 Ventilation

[0305] Adaptive servo-ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation but is variable. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's breathing characteristics).

[0306] Backup rate: A parameter of the ventilator that establishes the minimum respiratory rate (typically, breaths per minute) delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0307] Cycle: The end of the inspiratory phase of the ventilator. When delivering breaths from the ventilator to a patient who is breathing spontaneously, the ventilator is said to cycle to stop breath delivery at the end of the inspiratory portion of the breathing cycle.

[0308] Expiratory positive airway pressure (EPAP): The base pressure to which a pressure that varies within the breath is added for the generation of a desired interface pressure that the ventilator attempts to achieve at a given time. The base pressure to which a pressure that varies within the breath is added for the generation of a desired interface pressure that the ventilator attempts to achieve at a given time.

[0309] End expiratory pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) is zero at the end of expiration (i.e., Π(Φ)=0 when Φ = 1), EEP is equal to EPAP.

[0310] Inspiratory positive airway pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0311] Pressure support: A number indicating the pressure increase during ventilator inspiration compared to ventilator expiration, mainly meaning the pressure difference between the maximum value during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support means the difference that the ventilator attempts to achieve (rather than the difference that the ventilator actually achieves).

[0312] Servo ventilator: A ventilator with patient ventilation and target ventilation that adjusts the pressure support level to bring patient ventilation closer to the target ventilation.

[0313] Spontaneous / Triggering (S / T): A mode of a ventilator or other device that attempts to detect the start of a breath in a patient who is breathing spontaneously. However, if the device is unable to detect a breath within a predetermined period, the device automatically initiates breath delivery.

[0314] Swing: A term corresponding to pressure assistance.

[0315] Trigger: When a ventilator delivers a breath of air to a patient who is breathing spontaneously, when the patient himself / herself starts the breathing part of the breathing cycle, it is said that the ventilator is triggered to perform breath delivery. 4.13 Other Precautions

[0316] Part of the disclosure of this patent document includes content that is given copyright protection. The copyright owner has no objection if anyone reproduces this patent document or this patent disclosure by fax, provided that it is for the purpose of what is described in the patent file or record of the Patent Office, but retains all copyrights for other purposes.

[0317] Unless otherwise clearly apparent from the context and unless a range of values is provided, each intervening value between one-tenth of the unit of the lower limit, between the upper and lower limits of the range, and any other stated value or intervening value in the stated range of the description is understood to be encompassed by the technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limitations in the stated range, they are still encompassed by the technology. If the stated range includes one or both of these limitations, ranges exceeding either or both of these stated limitations are also encompassed by the technology.

[0318] Furthermore, when a value (singular or plural) is embodied as part of the technology in this specification, unless otherwise specified, it is understood that such a value can be approximated and such a value can be used to any appropriate significant digit up to the extent permitted or required by the actual technical implementation.

[0319] Unless otherwise specified, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described in this specification can be used in the practice or testing of this technology, only a limited number of exemplary methods and materials are described in this specification. are described herein.

[0320] Although specific materials are described as being preferably used in the construction of components, obvious alternative materials with similar properties can be used as substitutes. Further, unless stated to the contrary, any and all components described in this specification are understood to be manufacturable and can be manufactured either collectively or individually.

[0321] As used in this specification and the appended claims, it should be noted that the singular forms "a", "an", and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0322] All of the publications described in this specification are hereby incorporated by reference for the disclosure and description of the methods and / or materials for which they are the subject. The publications described in this specification are provided only for their disclosure prior to the filing date of this application. Nothing in this specification should be construed as an admission that the technology described herein does not antedate such publications by virtue of prior invention. Further, the dates of the publications described may be different from the actual publication dates and may need to be individually verified.

[0323] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the recited elements, components, or steps can be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0324] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the entire scope of the claims. These headings should not be used in the interpretation of the claims or the scope of the limitations of the claims.

[0325] Regarding the technology in this specification, specific embodiments have been described with reference to them, but it should be understood that these embodiments are merely illustrative of the principles and applications of this technology. In some cases, terms and symbols may indicate specific details that are unnecessary for the implementation of this technology. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Furthermore, when describing or exemplifying the process steps in this method, they may be presented in an ordered manner, but such an order is not necessary. A person skilled in the art will recognize that such an order can be changed and / or that it is possible to perform the manner simultaneously or further synchronously.

[0326] Therefore, it should be understood that numerous variations are possible in the exemplary embodiments and that other arrangements can be devised without departing from the spirit and scope of this technology.

Claims

Claim 1. A method comprising: receiving, from an interface, an input indicating that a patient desires to port a prescription treatment setting from a first respiratory therapy device to a second respiratory therapy device; receiving, through the interface, an account ID associated with the patient, a hardware identifier associated with the first respiratory therapy device, and a hardware identifier associated with the second respiratory therapy device; and sending a request including the account ID and the hardware identifier associated with the first respiratory therapy device to a prescription server to obtain the prescription treatment setting of the first respiratory therapy device from the prescription server, and retrieving the prescription treatment setting of the first respiratory therapy device from the prescription server; receiving the prescription treatment setting of the first respiratory therapy device from the prescription server based on the account ID; and storing the prescription treatment setting of the first respiratory therapy device in a memory of the second respiratory therapy device. Claim 2. Receiving a prescription treatment setting from the prescription server comprises: retrieving a respiratory quality indicator referenced for the account ID based on a respiratory therapy data output from the first respiratory therapy device; and determining whether the respiratory quality indicator exceeds a threshold; and if the respiratory quality indicator is below the threshold, flagging the patient for follow-up and rejecting the request to port the prescription treatment setting. The method according to claim 1, further comprising. Claim 3. The method according to claim 2, wherein the respiratory quality indicator is an apnea hypopnea index. Claim 4. Receiving a prescription treatment setting from the prescription server comprises: determining an elapsed time from a date associated with a current prescription treatment setting to a current date; determining whether the elapsed time exceeds a threshold; and if the elapsed time exceeds the threshold, flagging the patient in a prescription treatment database for follow-up and rejecting the request to port the prescription treatment setting. The method according to claim 1 or 2, further comprising. Claim 5. Receiving a prescription treatment setting from the prescription server comprises: requesting a set of information from the patient; Determining whether a significant change has occurred in relation to the prescription treatment setting based on the evaluation of the information; and if the significant change has occurred, further comprising flagging the patient in a prescription database for follow-up and rejecting the request to port the prescription treatment setting, the method according to claim 1. **Claim 6** The method according to claim 5, wherein the set of information includes at least one of a change in body weight, a change in BMI, and a change in muscle tone. **Claim 7** Receiving the prescription treatment setting from the prescription server comprises: requesting a set of oximeter data outputs from a pulse oximeter; determining whether the prescription treatment setting should be updated by processing the oximeter data; and if the prescription treatment setting should not be updated, further comprising flagging the patient in a prescription treatment database for follow-up and rejecting the request to port the prescription treatment setting, the method according to claim 1. **Claim 8** The method according to claim 5 or claim 6, wherein the set of information includes voice data received through a microphone, and determining whether there is a significant change in the tone of the patient's voice by processing the voice data. **Claim 9** The method according to claim 5 or claim 6, wherein the set of information includes face image data, and identifying a significant face change by comparing the face image data with pre-captured image data. **Claim 10** The method according to claim 9, wherein the significant face change indicates a significant change in BMI. **Claim 11** The method according to claim 1, wherein the prescription treatment setting is received via a cellular antenna connected to the first respiratory treatment device. **Claim 12** The method according to claim 1, wherein the prescription treatment setting is received via a Bluetooth (registered trademark) or Wi-Fi connection to a device connected to the first respiratory treatment device. **Claim 13** The method according to claim 11 or 12, wherein the prescription treatment setting is encrypted from the prescription server to the first respiratory treatment device. **Claim 14** The method according to claim 1, wherein the prescription treatment setting includes minimum and maximum pressures and a treatment mode. **Claim 15** Receiving, via the interface, an account ID associated with the patient's account and a serial number associated with the second respiratory therapy device: Displaying a code on a display of the first respiratory therapy device; Requesting an input of the code on the interface; and When the code is validated, receiving only general settings and prescription treatment settings, the method according to claim 1.

16. Receiving the prescription treatment settings further includes performing a conversion of the prescription treatment settings by a predetermined conversion factor based on a difference between the first and second respiratory therapy devices, the method according to claim 1.

17. A method comprising: Receiving, from an interface, an input indicating that a patient wishes to port prescription treatment settings from a second respiratory therapy device; Receiving, through the interface, an account ID associated with the patient and a serial number associated with the second respiratory therapy device; and Sending a request including the account ID and the serial number to a patient server to retrieve the prescription treatment settings of the second respiratory therapy device from a prescription server; When the serial number is validly associated with the account ID, receiving the prescription treatment settings of the second respiratory therapy device from the patient server based on a prescription ID; and Storing the prescription treatment settings of the second respiratory therapy device in a memory of the first respiratory therapy device, the method.

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