System and method for monitoring patient interface

Abstract

In one form of the present technology, a system for analyzing high flow respiratory therapy may include: a blower; a nasal cannula wherein an airflow travels along a flow path from the blower to the nasal cannula during administration of the high flow rate respiratory therapy; a sensor provided along the flow path; and a processor configured to perform the steps of: receiving data from the sensor; comparing the data received from the sensor to a threshold value; determining, based at least in part on the comparison, whether the nasal cannula is misaligned on or displaced from the patient; when it is determined that the nasal cannula is misaligned on the patient or displaced from the patient, an alarm signal is sent, and the alarm signal indicates that the nasal cannula is misaligned on the patient or displaced from the patient.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Application No. 63 / 489,295, filed March 9, 2023, the entire contents of which are incorporated herein by reference. Background Art 2.1 Technical Field

[0003] This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0004] 2.2 Description of relevant technologies

[0005] 2.2.1 The Human Respiratory System and Its Disorders

[0006] The human respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0007] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is known as the respiratory zone. See John B. West's *Respiratory Physiology*, 9th edition, Lippincott Williams & Wilkins, 2012.

[0008] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0009] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related malventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0010] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may cover some or all of the following disorders.

[0011] Patients with respiratory insufficiency (a form of respiratory failure) may experience unusual shortness of breath during exercise.

[0012] Obesity-induced dyspnea syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness in the absence of other known causes of dyspnea. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These characteristics include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0014] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0015] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0016] A range of therapies have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these therapies have many drawbacks.

[0017] 2.2.2 Treatment

[0018] Various respiratory therapies, such as non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0019] 2.2.2.1 Respiratory pressure therapy

[0020] Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic ventilators).

[0021] 2.2.2.2 Flow Therapy

[0022] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one example, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that can be maintained substantially constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway inlet improves ventilation efficiency by flushing or removing exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead-zone therapy (DST). Other benefits may include increased warmth and humidification (which may be beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies with the respiratory cycle.

[0023] 2.2.2.3 Supplementing oxygen

[0024] For some patients, oxygen therapy can be combined with respiratory pressure therapy (RPT) or high-pressure airflow (HFT) by adding supplemental oxygen to the pressurized airflow. When oxygen is added to RPT, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0025] 2.2.3 Respiratory Therapy System

[0026] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0027] A respiratory therapy system may include a respiratory pressure therapy device (RPT device) or other respiratory therapy device (RT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0028] 2.2.3.1 Patient Interface

[0029] Patient interfaces can be used to attach respiratory devices to their wearers, for example, by providing airflow to the airway inlet. For flow-based therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0030] 2.2.3.2 Respiratory Therapy (RT) Device

[0031] RT devices can be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an airflow for delivery to an interface in the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, RT devices can also be used as flow therapy devices. Examples of RT devices include CPAP devices and ventilators.

[0032] Device designers may face an almost limitless number of choices. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute variations in one or more parameters.

[0033] 2.2.3.3 Air Circuit

[0034] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system (such as an RT device and a patient interface) during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0035] 2.2.3.4 Humidifier

[0036] Delivering an airflow without humidification can lead to airway dryness. Using a humidifier with an RT device and patient interface produces humidified gas that minimizes nasal mucosal dryness and increases patient airway comfort. Additionally, in cooler climates, warm air applied to the area inside and around the patient interface is generally more comfortable than cold air.

[0037] 2.2.3.5 Data Management

[0038] There may be clinical reasons for obtaining data to determine whether a patient receiving respiratory therapy has "adhered" to treatment, such as the patient having used their RT device according to one or more "adherence rules." To determine patient adherence, the RT device provider (such as a healthcare provider) may manually obtain data describing the treatment used by patients using the RT device, calculate usage rates over a predetermined time period, and compare them to adherence rules. Once the healthcare provider has determined that the patient has used their RT device according to adherence rules, the healthcare provider may notify a third party that the patient is adherent.

[0039] The patient's treatment may benefit from other aspects of communicating treatment data to third parties or external systems.

[0040] Existing processes for communicating and managing this type of data may suffer from one or more of the following problems: high cost, time-consuming, and error-prone.

[0041] 2.2.4 Screening, Diagnosis and Monitoring System

[0042] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary diseases, and it typically involves clinical specialists applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalograms (EEG), electrocardiograms (ECG), electrooculograms (EOG), and electromyograms (EMG). PSG used to treat sleep-disordered breathing involves two nights of observation in a clinic: one night for pure diagnosis, and the second night for titration of treatment parameters by a clinician. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0043] Screening and diagnosis are generally described as identifying a condition based on its signs and symptoms. Screening typically provides a true / false result, indicating whether a patient's SDB is severe enough to require further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis are often one-off processes, while monitoring the progression of the condition can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0044] Clinicians may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may be unavailable or patients may not be able to afford clinician fees. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Summary of the Invention

[0045] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0046] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0047] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0048] One aspect of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0049] Another aspect of this technology is a series of modular elements that can be interconnected to form different styles of patient interfaces.

[0050] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably to form different modular components.

[0051] In one form of the present technology, a system for analyzing high-flow-rate respiratory therapy may include: a blower; a nasal cannula, wherein during administration of the high-flow-rate respiratory therapy, airflow travels along a flow path from the blower to the nasal cannula; a sensor disposed along the flow path; and a processor configured to perform the following steps: receiving data from the sensor; comparing the data received from the sensor with a threshold; determining, at least in part, whether the nasal cannula is misaligned or displaced from the patient; and, upon determining that the nasal cannula is misaligned or displaced from the patient, sending an alarm signal indicating that the nasal cannula is misaligned or displaced from the patient.

[0052] In some forms, the processor and the blower can be located within a respiratory therapy device.

[0053] In various aspects, the system may further include a conduit that connects to the nasal cannula at an interface, where the sensor is located.

[0054] In at least some examples, the sensor is a pressure sensor, and the threshold is the amplitude of the pressure waveform.

[0055] In various forms, this threshold can be a patient-specific threshold.

[0056] In a further form, the patient-specific threshold can be based on the analysis of data obtained from the sensor during calibration.

[0057] In each of these aspects, the patient-specific thresholds can be generated based on machine learning.

[0058] In at least some forms, the sensor may be a first sensor, and the system may further include a second sensor, the step of which further includes: receiving data from the second sensor; and evaluating the efficacy of the breathing therapy based at least in part on the data received from the second sensor.

[0059] The alarm signal can be sent to the patient in various forms.

[0060] In various aspects, the alarm signal may include a report provided to the healthcare provider.

[0061] In another form, a system for analyzing high-flow-rate respiratory therapy may include: a respiratory therapy device; a nasal cannula; a conduit configured to connect to the nasal cannula at an interface, wherein during administration of the high-flow-rate respiratory therapy, airflow passes from the respiratory therapy device through the conduit and travels to the nasal cannula; a pressure sensor disposed in, on, or at the interface of the nasal cannula; and a processor configured to perform the following steps: receiving data from the pressure sensor; analyzing the data received from the pressure sensor; determining, at least in part based on the analysis, whether the nasal cannula is misaligned or displaced from the patient by comparing the amplitude of the pressure waveform of the received data with a threshold amplitude; and, upon determining that the nasal cannula is misaligned or displaced from the patient, sending an alarm signal indicating that the nasal cannula is misaligned or displaced from the patient.

[0062] In various forms, the processor can be incorporated into the respiratory therapy device.

[0063] In various aspects, the analysis includes comparing the data received from the pressure sensor with patient-specific thresholds.

[0064] In some forms, the patient-specific threshold can be based on analysis of data obtained from the pressure sensor during calibration.

[0065] In a further form, the patient-specific threshold can be generated based on machine learning.

[0066] In various aspects, the system may include a second sensor, and the step further includes: receiving data from the second sensor; and evaluating the efficacy of the respiratory therapy from the respiratory therapy device based at least in part on the data received from the second sensor.

[0067] In other forms, the system may include a second sensor, which is a different type of sensor from the first sensor.

[0068] The alarm signal can be sent to the patient in various forms.

[0069] In some respects, the alarm signal may include a report provided to the healthcare provider.

[0070] In yet another example, a system for analyzing high-flow-rate respiratory therapy may include: a blower; a nasal cannula, wherein during administration of the high-flow-rate respiratory therapy, airflow travels along a flow path from the blower to the nasal cannula; a pressure sensor disposed along the flow path; and a processor configured to perform the following steps: receiving data from the pressure sensor; comparing the amplitude of a pressure waveform of the data received from the pressure sensor with a patient-specific threshold; analyzing, based on the comparison, the positioning of the nasal cannula or an aspect of the patient's breathing; and, based on the analysis, sending an alarm signal to the patient when the analysis indicates an incorrect positioning of the nasal cannula or a deviation in that aspect of the patient's breathing.

[0071] One aspect of this technology is a method for manufacturing equipment.

[0072] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0073] One aspect of this technology is a portable RT device that can be carried by a person (e.g., in that person's home).

[0074] The described methods, systems, apparatuses, and devices can be implemented to improve the functionality of processors (such as processors in dedicated computers, respiratory monitors, and / or respiratory therapy devices). Furthermore, the described methods, systems, apparatuses, and devices can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0075] Of course, the various parts of these aspects can form sub-aspects of this technology. Furthermore, these sub-aspects and / or the various sub-aspects and / or aspects within these aspects can be combined in various ways and also constitute additional aspects or sub-aspects of this technology.

[0076] Other features of the present technology will become apparent from the following detailed description, summary of the specification, drawings and claims. Attached Figure Description

[0077] The technology is illustrated in the accompanying drawings by way of example and not limitation, wherein similar reference numerals refer to similar elements, including:

[0078] 4.1 Breathing Therapy System

[0079] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000, receiving an air (e.g., positive pressure air) supply from a respiratory therapy (“RT”) device 4000. The air from the RT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine position.

[0080] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000, receiving an air supply from an RT device 4000. The air from the RT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0081] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000, receiving an air supply from an air reflux device 4000. The air from the air reflux device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a side-lying position.

[0082] 4.2 Respiratory System and Facial Anatomy

[0083] Figure 2 A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0084] 4.3 Patient Interface

[0085] Figure 3 A patient interface in the form of a nasal cannula according to the present technology is shown.

[0086] 4.4RT device

[0087] Figure 4A An RT device of one form according to the present technology is shown.

[0088] Figure 4BThis is a schematic diagram of the pneumatic path of one form of RT device according to the present technology. The upstream and downstream directions are indicated with reference to a blower and a patient interface. The blower is positioned upstream of the patient interface, and the patient interface is positioned downstream of the blower, regardless of the actual flow direction at any given moment. Objects located within the pneumatic path between the blower and the patient interface are positioned downstream of the blower and upstream of the patient interface.

[0089] Figure 4C This is a schematic diagram of the electrical components of one type of RT device according to the present technology.

[0090] Figure 4D This is a schematic diagram of an algorithm implemented in an RT device according to one form of the present technology.

[0091] Figure 5A A system is described for detecting and / or communicating patient interface deviation, for assessing therapy, or for assessing patient breathing.

[0092] Figure 5B Depicting and Figure 5A The system uses various aspects of the patient interface.

[0093] Figure 6A A flowchart of a method for detecting patient interface deviation is shown.

[0094] Figure 6B A flowchart is shown for a method of evaluating and adjusting therapy.

[0095] Figure 6C A flowchart is shown for a method of generating patient-specific thresholds for evaluation.

[0096] Figure 6D A flowchart is shown that uses patient-specific thresholds to assess patient interface positioning, therapy parameters, or patient respiratory parameters.

[0097] 4.5 Respiratory waveform

[0098] Figure 7A A typical breathing waveform model of a person sleeping is shown.

[0099] Figure 7B The typical pressure waveform of the respiratory cycle is shown. Detailed Implementation

[0100] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and the specific examples described herein may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples discussed herein and is not intended to be limiting.

[0101] The following description provides various examples of which may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Furthermore, any single feature or combination of features from any of the examples may constitute another example.

[0102] 5.1 Therapy

[0103] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the inlet of the airway of a patient 1000.

[0104] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0105] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0106] 5.2 Respiratory Therapy System

[0107] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0108] 5.3 Patient Interface

[0109] like Figure 3As shown, the unsealed patient interface 3800 in the form of a nasal cannula includes nasal forks 3810a, 3810b that can deliver air to the corresponding nostrils of a patient 1000 via corresponding orifices in their tips. Such nasal forks typically do not form a seal with the inner or outer skin surface of the nostril. This type of interface creates one or more gaps that are intentionally present by design during use, but they are generally not fixed in size, making them susceptible to unpredictable changes due to movement during use. Unlike other types of mask-based respiratory therapy systems, this allows for complex aerodynamic variables in the respiratory therapy system when control and / or evaluation are achieved. Air to the nasal forks can be delivered via one or more air supply lumens 3820a, 3820b coupled to the unsealed patient interface 3800 in the form of a nasal cannula. Lumens 3820a, 3820b extend from the unsealed patient interface 3800 in the form of a nasal cannula to the respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivering flow therapy, where the RT device generates an airflow at a controlled flow rate rather than a controlled pressure. The “vent” or gap at the unsealed patient interface 3800 is a passage between the ends of the forks 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800, leading to the atmosphere via the patient's nostrils. Excess airflow escapes into the environment through this “vent” or gap.

[0110] 5.4 Therapeutic Device

[0111] RT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as any of the methods described herein, in whole or in part. RT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0112] In one embodiment, the RT device 4000 is configured and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0113] The RT device 4000 may have an outer housing 4010, which is formed in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RT device 4000 includes a chassis 4016 that supports one or more internal components of the RT device 4000. The RT device 4000 may include a handle 4018.

[0114] The pneumatic path of the RT device 4000 may include one or more air path objects, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0115] One or more of the air path components may be located within a removable integral structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be located within an outer housing 4010. In one form, pneumatic block 4020 is supported by or formed as part of a chassis 4016.

[0116] like Figure 4C As shown, the RT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230 (e.g., a processor), a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. Alternatively, the RT device 4000 may include more than one PCBA 4202.

[0117] 5.4.1 Mechanical and pneumatic components of the RT device

[0118] The therapeutic device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be positioned as respective individual units.

[0119] 5.4.1.1 Air Filter

[0120] A therapeutic device of this technology (such as RT device 4000) may include an air filter 4110 or a plurality of air filters 4110.

[0121] exist Figure 4B In one of the illustrated configurations, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0122] exist Figure 4B In one of the illustrated forms, an outlet air filter 4114, such as an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0123] 5.4.1.2 Muffler

[0124] One form of RT device according to the present technology may include one or more silencers 4120.

[0125] In one form of this technology (see, for example, see...) Figure 4B The inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0126] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0127] 5.4.1.3 Pressure Generator

[0128] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may deliver an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0129] The pressure generator 4140 can be controlled by the therapy device controller 4240.

[0130] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0131] 5.4.1.4 Transducer

[0132] The transducer can be inside or outside the RT device. An external transducer can be located on, for example, an air circuit (e.g., a patient interface) or form part of an air circuit. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that sends or transmits data to or from the RT device.

[0133] In one form of this technology (see example) Figure 4BOne or more transducers 4270 are located upstream and / or downstream of pressure generator 4140. One or more transducers 4270 may be configured and arranged to generate signals representing characteristics of airflow, such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0134] In one form of this technology, one or more transducers 4270 may be located near the patient interface 3000 or 3800.

[0135] In one embodiment, the signal from transducer 4270 can be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0136] 5.4.1.4.1 Flow Sensor

[0137] The flow sensor 4274 according to this technology can be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from SENSIRION, Switzerland.

[0138] In one configuration, the signal generated by the flow sensor 4274 and representing the flow rate is received by the central controller 4230.

[0139] 5.4.1.4.2 Pressure Sensor

[0140] The pressure sensor 4272 according to this technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. An alternative suitable pressure sensor is a transducer from the GENERALELECTRIC NPA series.

[0141] In one configuration, the signal generated by pressure sensor 4272 and representing pressure is received by central controller 4230.

[0142] 5.4.1.4.3 Motor speed transducer

[0143] In one embodiment of this technology, a motor speed transducer 4276 is used to determine the rotational speed of a motor 4144 and / or a blower 4142. The motor speed signal from the motor speed transducer 4276 can be provided to a therapy device controller 4240. The motor speed transducer 4276 can be, for example, a speed sensor, such as a Hall effect sensor.

[0144] 5.4.1.5 Anti-overflow valve

[0145] like Figure 4B As shown, in one form of this technology, an anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0146] 5.4.2 Electrical components of the RT device

[0147] 5.4.2.1 Input Device

[0148] In one form of this technology, the RT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow human interaction with the device. The buttons, switches, or dials can be physical devices or software devices accessible via a touchscreen. In one form, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another form, they can communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0149] In one form, the input device 4220 may be configured and arranged to allow a person to select values ​​and / or menu options.

[0150] 5.4.2.2 Central Controller

[0151] In one embodiment of this technology, the central controller 4230 is one or more processors adapted to control the RT device 4000. The central controller 4230 in... Figure 4C Shown in.

[0152] Suitable processors may include x86 Intel processors, based on ARM Holdings' architecture. Processors such as ST Microelectronics' STM32 series microcontrollers. In some alternative forms of this technology, 32-bit RISC CPUs, such as ST Microelectronics' STR9 series microcontrollers, or 16-bit RISC CPUs, such as processors from Texas Instruments' MSP430 family of microcontrollers, can also be used.

[0153] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0154] In one form, the central controller 4230 is an application-specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0155] The central controller 4230 can be configured to receive input signals from one or more transducers 4270, one or more input devices 4220, and / or the humidifier 5000.

[0156] The central controller 4230 can be configured to provide output signals to one or more of the output device 4290, pressure generator 4140, therapy device controller 4240, data communication interface 4280, and humidifier 5000.

[0157] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that can be implemented using processor control instructions, which are represented as a computer program stored in a non-transitory computer-readable storage medium (such as memory 4260). In some forms of this technology, the central controller 4230 may be integrated with the RT device 4000. However, in some forms of this technology, some methods may be performed by a remotely located device. For example, a remotely located device may determine the control settings of a ventilator or detect respiratory-related events by analyzing stored data (such as data from any of the sensors described herein).

[0158] 5.4.2.3 Clock

[0159] The RT device 4000 may include a clock 4232 connected to the central controller 4230.

[0160] 5.4.2.4 Therapeutic Device Controller

[0161] In one form of this technology, the therapy device controller 4240 is a therapy control module 4330, which forms part of an algorithm 4300 executed by the central controller 4230.

[0162] In one embodiment of this technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0163] 5.4.2.5 Protection Circuit

[0164] One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0165] 5.4.2.6 Memory

[0166] According to one embodiment of the present technology, the RT device 4000 includes a memory 4260, such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0167] The memory 4260 can be located on PCBA 4202. The memory 4260 can be in the form of EEPROM or NAND flash memory.

[0168] Additionally or alternatively, the RT device 4000 includes a removable memory 4260, such as a memory card manufactured according to the Secure Digital (SD) standard.

[0169] In one form of the present technology, memory 4260 acts as a non-transitory computer-readable storage medium storing computer program instructions, such as one or more algorithms 4300, representing one or more methods described herein.

[0170] 5.4.2.7 Data Communication System

[0171] In one form of this technology, a data communication interface 4280 is provided, which is connected to a central controller 4230 (see, for example, [link to relevant documentation]). Figure 4C The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0172] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0173] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0174] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0175] In one form, the remote external device 4286 is one or more computers, such as a cluster of networked computers. In another form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible to a properly authorized person, such as a clinician.

[0176] The local external device 4288 can be a personal computer, mobile phone, tablet or remote control device.

[0177] 5.4.2.8 Includes optional display and alarm output devices.

[0178] The output device 4290 according to this technology can take the form of one or more of a visual, audio, and tactile unit. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0179] 5.4.2.8.1 Display Driver

[0180] The display driver 4292 receives characters, symbols, or images to be displayed on the display 4294 as input and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0181] 5.4.2.8.2 Monitor

[0182] Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals that indicate whether the eight corresponding segments will be activated to display a specific character or symbol.

[0183] 5.4.3 RT Device Algorithm

[0184] As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer-readable storage medium (such as memory 4260). The algorithms 4300 are typically grouped into groups called modules.

[0185] In other forms of this technology, a portion or all of algorithm 4300 may be implemented by the controller of an external device, such as a local external device 4288 or a remote external device 4286. In this form, the input signals and / or intermediate algorithm outputs required to represent the portion of algorithm 4300 to be executed at the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In this type of form, the portion of algorithm 4300 to be executed at the external device may be represented as a computer program, such as having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute portions of algorithm 4300.

[0186] In this form, therapeutic parameters generated by an external device via the therapeutic engine module 4320 (if thus forming part of the algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 to be passed to the therapeutic control module 4330.

[0187] 5.4.3.1 Preprocessing Module

[0188] According to one form of the present technology, a preprocessing module 4310 receives a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272) as input and performs one or more processing steps to calculate one or more output values ​​that will be used as input to another module (e.g., a therapy engine module 4320).

[0189] In one form of this technology, the output values ​​include interface pressure Pm, ventilation flow rate Qv, breathing flow rate Qr, and leakage flow rate Ql.

[0190] In various forms of this technology, the preprocessing module 4310 includes one or more of the following algorithms: interface pressure estimation 4312, ventilation flow estimation 4314, leakage flow estimation 4316, and breathing flow estimation 4318.

[0191] 5.4.3.1.1 Interface stress estimation

[0192] In one form of this technology, the interface pressure estimation algorithm 4312 receives a signal from pressure sensor 4272 representing the pressure (device pressure Pd) in the pneumatic path near the pneumatic block outlet and a signal from flow sensor 4274 representing the flow rate (device flow rate Qd) of the airflow leaving the RT device 4000 as inputs. The device flow rate Qd without any supplementary gas 4180 can be used as the total flow rate Qt. The interface pressure algorithm 4312 estimates the pressure drop P through the air circuit 4170. For a given air circuit 4170, the dependence of the pressure drop P on the total flow rate Qt can be modeled by the pressure drop characteristic P(Q). The interface pressure estimation algorithm 4312 then provides an estimated pressure Pm as output in the patient interface 3000 or 3800. The pressure Pm in the patient interface 3000 or 3800 can be estimated as the device pressure Pd minus the air circuit pressure drop P.

[0193] 5.4.3.1.2 Ventilation flow rate estimation

[0194] In one form of this technology, the ventilation flow rate estimation algorithm 4314 receives the estimated pressure Pm in the patient interface 3000 or 3800 as input from the interface pressure estimation algorithm 4312, and estimates the air ventilation flow rate Qv from the vent 3400 in the patient interface 3000 or 3800. For a specific vent 3400 in use, the dependence of the ventilation flow rate Qv on the interface pressure Pm can be modeled by the ventilation characteristic Qv(Pm).

[0195] 5.4.3.1.3 Leakage Flow Estimation

[0196] In one form of this technology, the leakage flow estimation algorithm 4316 receives the total flow rate Qt and the ventilation flow rate Qv as inputs and provides an estimate of the leakage flow rate Ql as output. In another form, the leakage flow estimation algorithm estimates the leakage flow rate Ql by calculating the average of the difference between the total flow rate Qt and the ventilation flow rate Qv over a sufficiently long time period (e.g., approximately 10 seconds) that includes several respiratory cycles.

[0197] In one form, the leakage flow estimation algorithm 4316 receives the total flow rate Qt, ventilation flow rate Qv, and estimated pressure Pm from the patient interface 3000 or 3800 as input and provides the leakage flow rate Ql as output. It calculates the leakage conductance and determines that the leakage flow rate Ql is a function of the leakage conductance and pressure Pm. The leakage conductance is calculated as the low-pass filtered non-ventilation flow rate equal to the quotient of the difference between the total flow rate Qt and the ventilation flow rate Qv and the square root of the low-pass filtered pressure Pm, where the low-pass filtered time constant has a sufficiently long time to include values ​​over several respiratory cycles, for example, approximately 10 seconds. The leakage flow rate Ql can be estimated as the product of the leakage conductance and the pressure function Pm.

[0198] 5.4.3.1.4 Respiratory Flow Estimation

[0199] In one form of this technology, the respiratory flow estimation algorithm 4318 receives total flow Qt, ventilation flow Qv, and leakage flow Ql as inputs, and estimates the patient's air respiratory flow Qr by subtracting ventilation flow Qv and leakage flow Ql from the total flow Qt.

[0200] 5.4.3.2 Therapy Engine Module

[0201] In one form of this technology, the therapy engine module 4320 receives one or more of the pressure Pm in the patient interface 3000 or 3800 and the respiratory flow rate Qr of the air to the patient as input, and provides one or more therapy parameters as output.

[0202] In one form of this technique, the therapeutic parameter is the therapeutic pressure Pt.

[0203] In one form of this technique, the therapeutic parameters are one or more of the following: pressure variation amplitude, baseline pressure, and target ventilation.

[0204] In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow restriction determination 4324, apnea / insufficiency determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapy parameter determination 4329.

[0205] 5.4.3.2.1 Phase Determination

[0206] In one form of this technology, the RT device has an uncertain phase of 4000.

[0207] In one form of this technology, the phase determination algorithm 4321 receives a signal indicating respiratory flow Qr as input and provides the phase of the patient's current respiratory cycle 1000 as output.

[0208] In some forms, this is called discrete phase determination, where the phase output is a discrete variable. One specific implementation of discrete phase determination provides a dual-valued phase output with either an inhalation or exhalation value, for example, values ​​represented as 0 revolutions and 0.5 revolutions respectively when spontaneous inhalation and exhalation are detected. The “triggering” and “cycling” RT device 4000 effectively performs discrete phase determination because the trigger point and cycling point are the moments when the phase changes from exhalation to inhalation and from inhalation to exhalation, respectively. In one specific implementation of dual-valued phase determination, the phase output is determined to have a discrete value of 0 when the respiratory flow Qr has a value exceeding a positive threshold (thus “triggering” the RT device 4000), and a discrete value of 0.5 revolutions when the respiratory flow Qr has a value more negative than a negative threshold (thus “cycling” the RT device 4000). The inhalation time Ti and exhalation time Te can be estimated as typical values ​​over many respiratory cycles of the time taken for the phase to be equal to 0 (indicating inspiration) and 0.5 (indicating exhalation), respectively.

[0209] Another implementation of discrete phase determination provides a three-valued phase output having a value of one of inhalation, intermediate inspiratory pause, and exhalation.

[0210] In other forms known as continuous phase determination, the phase output is a continuous variable, such as changing from 0 revolutions to 1 revolution, or from 0 to 2 radians. The RT device 4000 performing continuous phase determination can be triggered and cycled when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one specific implementation of continuous phase determination, fuzzy logic analysis of the respiratory flow rate Qr is used to determine the continuous value of the phase. The continuous value of the phase determined in this specific implementation is often referred to as the "fuzzy phase." In one embodiment of the fuzzy phase determination algorithm 4321, the following rule is applied to the respiratory flow rate Qr:

[0211] 1. If Qr is zero and increases rapidly, then it is 0 revolutions.

[0212] 2. If Qr is a large positive value and stable, then it is 0.25 revolutions.

[0213] 3. If Qr is zero and decreases rapidly, then it is 0.5 revolutions.

[0214] 4. If Qr is a large negative value and stable, then it is 0.75 revolutions.

[0215] 5. If Qr is zero and stable, and the absolute value of the 5-second low-pass filter for Qr is large, then it is 0.9 revolutions.

[0216] 6. If Qr is positive and the phase is exhalation, then it is 0 revolutions.

[0217] 7. If Qr is negative and the phase is intake, then it is 0.5 revolutions.

[0218] 8. If the absolute value of the 5-second low-pass filter for Qr is large, then increase it at a steady rate equal to the patient’s respiratory rate and low-pass filter it with a time constant of 20 seconds.

[0219] The output of each rule can be represented as a vector, where the phase of the vector is the result of the rule, and its magnitude is the degree of ambiguity of the rule being true. Appropriate membership functions are used to determine the degree of ambiguity for terms such as "larger" or "stable" respiratory flow. The results of the rules are represented as vectors and then combined using a function such as centroid. In such combinations, rules can be weighted equally or differently.

[0220] In another embodiment of continuous phase determination, the phase is first estimated discretely based on the respiratory flow rate Qr as described above, as are the inhalation time Ti and exhalation time Te. The continuous phase at any given time can be determined as half of the inhalation time Ti that has elapsed since the previous trigger time, or 0.5 revolutions plus half of the exhalation time Te that has elapsed since the previous cycle time (whichever time is more recent).

[0221] 5.4.3.2.2 Waveform Determination

[0222] In one form of this technology, the therapy parameter determination algorithm 4329 provides an approximately constant therapeutic pressure throughout the patient's respiratory cycle.

[0223] In other forms of this technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapeutic pressure Pt that varies as a function of the phase of the patient's respiratory cycle, based on a waveform template.

[0224] In one form of this technology, waveform determination algorithm 4322 provides a waveform template () whose value in the range of [0,1] over the phase value range provided by phase determination algorithm 4321 will be used by therapy parameter determination algorithm 4329.

[0225] In a form suitable for discrete or continuous phase values, the waveform template ( ) is a square wave template with a value of 1 for phase values ​​up to and including 0.5 revolutions, and a value of 0 for phase values ​​greater than 0.5 revolutions. In a form suitable for continuous phase values, the waveform template ( ) includes two smooth curve portions: for phase values ​​up to 0.5 revolutions, the smooth curve portion (e.g., raised cosine) rises from 0 to 1, while for phase values ​​greater than 0.5 revolutions, the smooth curve portion (e.g., exponential) decays from 1 to 0. In a form suitable for continuous phase values, the waveform template ( ) is based on a square wave, but for phase values, it smoothly rises from 0 to 1 until the "rise time" is less than 0.5 revolutions, and for phase values, it smoothly falls from 1 to 0 within a "fall time" after 0.5 revolutions, where the "fall time" is less than 0.5 revolutions.

[0226] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template from a waveform template library based on the settings of the RT device. Each waveform template in the library can be provided as a lookup table of values ​​relative to the phase value. In other forms, the waveform determination algorithm 4322 calculates the waveform template "on the fly" using a predetermined function form that may be parameterized by one or more parameters (e.g., the time constant of the exponentially curved portion). The parameters of the function form can be predetermined or depend on the current state of the patient 1000.

[0227] In some forms of this technique applicable to discrete two-valued phases of inhalation (=0 rpm) or exhalation (=0.5 rpm), waveform determination algorithm 4322 calculates the waveform template "on demand, instantly," as a function of the discrete phase and the time t measured from the most recent trigger moment. In one such form, waveform determination algorithm 4322 calculates the waveform template (,t) in two parts (inhalation and exhalation) as follows:

[0228]

[0229] in i (t) and e (t) represents the inspiratory and exhalatory portions of the waveform template (,t). In one such form, the inspiratory portion of the waveform template... i (t) is a smooth rise from 0 to 1 parameterized by the rise time, and the expiratory portion of the waveform template. e (t) is a smooth descent from 1 to 0 parameterized by the descent time.

[0230] 5.4.3.2.3 Determination of ventilation volume

[0231] In one form of this technology, the ventilation determination algorithm 4323 receives input of respiratory flow Qr and determines a measurement indicating the current patient ventilation Vent.

[0232] In some implementations, the ventilation determination algorithm 4323 determines a measure of the ventilation volume Vent, which is an estimate of the actual patient ventilation volume. One such implementation is to take half the absolute value of the respiratory flow Qr, which may optionally be filtered by a low-pass filter such as a second-order Bessel low-pass filter with an angular frequency of 0.11 Hz.

[0233] In other implementations, the ventilation determination algorithm 4323 determines a measure of ventilation (Vent) that is approximately proportional to the actual patient ventilation. One such implementation estimates the peak respiratory flow (Q-peak) on the inspiratory portion of the cycle. If the shape of the flow waveform does not change significantly (here, the shapes of two breaths are considered similar when the flow waveforms of breaths normalized in time and amplitude are similar), this procedure, involving sampling the respiratory flow (Qr), and many other procedures, produces measurements that are approximately proportional to the ventilation. Some simple examples include the median of positive respiratory flow, the median of the absolute values ​​of respiratory flow, and the standard deviation of the flow. Any linear combination of any order of statistics for the absolute values ​​of respiratory flow with positive coefficients, and even some linear combinations of any order of statistics for the absolute values ​​of respiratory flow with both positive and negative coefficients, are approximately proportional to the ventilation. Another example is the average of the respiratory flow in the middle K proportion (by time) of the inspiratory portion, where 0 < K < 1. If the flow shape is constant, there are arbitrarily large numbers of measurements that are precisely proportional to the ventilation.

[0234] 5.4.3.2.4 Determination of Inspiratory Flow Limit

[0235] In one embodiment of this technology, the central controller 4230 executes an intake flow limit determination algorithm 4324 to determine the degree of intake flow limit.

[0236] In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow signal Qr as input and provides a measure of the degree to which the inspiratory portion of the breath exhibits inspiratory flow limitation as output.

[0237] In one form of this technique, the inspiratory portion of each breath is identified by a zero-crossing detector. An interpolator interpolates along the inspiratory flow-time curve of each breath to multiple evenly spaced points (e.g., 65) representing the time points. The curve described by the points is then scaled by a scalar to have a uniform length (duration / cycle) and a uniform area to eliminate the effects of variations in respiratory rate and depth. The scaled breath is then compared in a comparator to a pre-stored template representing normal unobstructed breathing, similar to... Figure 7AThe diagram shows the inspiratory portion of the breath. At any time during the inspiratory period from this template, breaths deviating beyond a specified threshold (typically 1 scaling unit) are rejected, such as those caused by coughing, sighing, swallowing, and hiccups as determined by the test element. For non-rejected data, the central controller 4230 calculates a moving average of the first such scaling point of the preceding few inspiratory events. For the second such point, this is repeated on the same inspiratory event, and so on. Thus, for example, 65 scaling data points are generated by the central controller 4230 and represent the moving average of the preceding few inspiratory events (e.g., three events). The moving average of the continuously updated values ​​of (e.g., 65) points is referred to below as the “scaling flow,” denoted as Qs(t). Alternatively, a single inspiratory event can be used instead of a moving average.

[0238] Based on the scaled flow rate, two shape factors can be calculated to determine the partial blockage.

[0239] The shape factor 1 is the ratio of the average of intermediate (e.g., 32) scaled flow points to the average of the total (e.g., 65) scaled flow points. When this ratio is greater than 1, breathing is considered normal. When the ratio is 1 or less, breathing is considered obstructed. A ratio of approximately 1.17 is considered the threshold between partially obstructed and unobstructed breathing, and is equivalent to the degree of obstruction that allows adequate oxygenation to be maintained in a typical patient.

[0240] The shape factor 2 is calculated as the RMS deviation from a unit scaled flow rate at an intermediate (e.g., 32) point. An RMS deviation of approximately 0.2 units is considered normal. Zero RMS deviation is considered a fully flow-restricted breath. The closer the RMS deviation is to zero, the more flow-restricted the breath will be considered.

[0241] Shape factors 1 and 2 can be used as alternatives or in combination. In other forms of this technique, the number of sampling points, breaths, and intermediate points can differ from those described above. Furthermore, the threshold can differ from the thresholds described.

[0242] 5.4.3.2.5 Determination of Apnea and Insufficient Respiration

[0243] In one form of this technology, the central controller 4230 executes an apnea / hypoventricular dysfunction determination algorithm 4325 to determine the presence of apnea and / or hypoventricular dysfunction.

[0244] In one form, the apnea / insufficiency determination algorithm 4325 receives the respiratory flow signal Qr as input and provides a flag indicating that apnea or insufficiency has been detected as output.

[0245] In one form, apnea is considered detected when a function of respiratory flow Qr falls below a flow threshold within a predetermined time period. This function can be determined as peak flow, a relatively short-term average flow, or an intermediate flow between the relatively short-term average and peak flow, such as RMS flow. The flow threshold can be a relatively long-term measurement of flow.

[0246] In one form, insufficiency is considered detected when a function of respiratory flow Qr falls below a second flow threshold within a predetermined time period. This function can be a peak flow, a relatively short-term average flow, or an intermediate flow between the relatively short-term average and peak flow, such as RMS flow. The second flow threshold can be a relatively long-term measurement of the flow. The second flow threshold is greater than the flow threshold used to detect apnea.

[0247] 5.4.3.2.6 Determining Snoring

[0248] In one form of this technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the degree of snoring.

[0249] In one form, the snoring determination algorithm 4326 receives a respiratory flow signal Qr as input and provides a measure of the degree of snoring presence as output.

[0250] The snoring determination algorithm 4326 may include the step of determining the intensity of the flow signal in the range of 30 Hz to 300 Hz. Furthermore, the snoring determination algorithm 4326 may include the step of filtering the respiratory flow signal Qr to reduce background noise (e.g., the sound of airflow from a blower in the system).

[0251] 5.4.3.2.7 Determination of airway patency

[0252] In one form of this technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 to determine the degree of airway patency.

[0253] In one embodiment, the airway patency determination algorithm 4327 receives a respiratory flow signal Qr as input and determines the power of the signal in a frequency range of approximately 0.75 Hz to approximately 3 Hz. The presence of a peak within this frequency range is considered an indication of an open airway. The absence of a peak is considered an indication of a closed airway.

[0254] In one form, the frequency range within which the peak is sought is the frequency of small forced oscillations in the therapeutic pressure Pt. In one embodiment, the forced oscillation frequency is 2 Hz, and the amplitude is approximately 1 cmH2O.

[0255] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as input and determines whether a cardiac signal is present. The absence of a cardiac signal is considered an indication of a closed airway.

[0256] 5.4.3.2.8 Determination of target ventilation

[0257] In one form of this technology, the central controller 4230 takes the measured value of the current ventilation volume Vent as input and executes one or more target ventilation volume determination algorithms 4328 to determine a target value Vtgt of the measured ventilation volume.

[0258] In some forms of this technology, there is no target ventilation determination algorithm 4328, and the target value Vtgt is predetermined, for example, by hard coding during the configuration of the RT device 4000 or by manual input via the input device 4220.

[0259] In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt based on the value Vtyp indicating the patient's typical recent ventilation.

[0260] In some forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated as a high percentage of the typical recent ventilation volume Vtyp, but less than that typical recent ventilation volume. This high percentage can be in the range of (80%, 100%), (85%, 95%), or (87%, 92%).

[0261] In other forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated as an integer multiple slightly larger than the typical recent ventilation volume Vtyp.

[0262] Typical recent ventilation (Vtyp) is the value at which the current ventilation measurement (Vent) tends to cluster over several moments on some predetermined time scales; that is, it is a measure of the central tendency of the current ventilation measurement in recent history. In one implementation of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case, it should be longer than the Cheyne-Stokes rise-fall cycle. The target ventilation determination algorithm 4328 can use any of a variety of known methods of measuring central tendency to determine the typical recent ventilation (Vtyp) based on the current ventilation measurement (Vent). One such measurement is the output of a low-pass filter on the current ventilation measurement (Vent), where the time constant is equal to 100 seconds.

[0263] 5.4.3.2.9 Determination of Therapeutic Parameters

[0264] In some forms of this technology, the central controller 4230 executes one or more therapy parameter determination algorithms 4329 to determine one or more therapy parameters using values ​​returned by one or more other algorithms in the therapy engine module 4320.

[0265] In one form of this technology, the therapeutic parameter is the instantaneous therapeutic pressure Pt. In a specific implementation of this form, the therapeutic parameter determination algorithm 4329 uses the following equation to determine the therapeutic pressure Pt:

[0266] Pt=AΠ(Φ,t)+P0 (1)

[0267] in:

[0268] A is the amplitude.

[0269] ·(t) is the waveform template value (in the range of 0 to 1) at the current value of the phase and time t, and

[0270] P0 is the base pressure.

[0271] If waveform determination algorithm 4322 provides waveform template (t) as a lookup table of values ​​indexed by phase, then therapeutic parameter determination algorithm 4329 applies equation (1) by locating the nearest lookup table entry to the current value of the phase returned by phase determination algorithm 4321, or by interpolating between two entries that span the current value of the phase.

[0272] Amplitude A and base pressure P The value of 0 can be determined by the therapy parameters. Algorithm 4329 sets the value according to the selected respiratory pressure therapy mode in the following manner.

[0273] 5.4.3.3 Therapy Control Module

[0274] According to one aspect of the present technology, the therapy control module 4330 receives therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 as input, and controls the pressure generator 4140 to deliver an airflow according to the therapy parameters.

[0275] In one form of this technology, the therapeutic parameter is the therapeutic pressure Pt, and the therapeutic control module 4330 controls the pressure generator 4140 to deliver an airflow at an interface pressure Pm equal to the therapeutic pressure Pt at the patient interface 3000 or 3800.

[0276] 5.4.3.4 Fault Detection

[0277] In one form of this technology, the central controller 4230 executes one or more methods 4340 for detecting fault conditions. The fault conditions detected by the one or more methods 4340 may include at least one of the following:

[0278] • Power failure (no power or insufficient power)

[0279] • Transducer fault detection

[0280] • The presence of the component cannot be detected

[0281] • Operating parameters are outside the recommended range (e.g., pressure, flow rate, temperature, PaO2).

[0282] • The test alarm failed to generate a detectable alarm signal.

[0283] When a fault condition is detected, the corresponding algorithm 4340 signals the presence of the fault through one or more of the following:

[0284] • Activate auditory, visual, and / or dynamic (e.g., vibration) alarms

[0285] • Send messages to external devices

[0286] Event Log

[0287] 5.4.3.5 Interface Parameter Detection

[0288] 5.4.3.5.1 Systems and apparatus for detecting interface parameters

[0289] During use, patient interface 3000 or 3800 may shift away from its original location and move out of patient 1000's nostrils, or may be incorrectly positioned relative to patient 1000's nostrils. Although patient interface 3800 is specifically referenced below, it should be understood that the systems and techniques described below are also applicable to other types of interfaces 3000. In some examples, patient interface 3800 may be completely detached from patient 1000's nostrils / patient 1000's face. In other examples, one or more of the forks 3810a, 3810b of patient interface 3800 may detach from patient 1000's nostrils (e.g., slide out). When patient interface 3800 is partially or entirely displaced, causing HFT not to be applied to patient 1000 as intended, HFT may be less effective. For example, patient 1000 may receive less air / oxygen than prescribed, and / or may receive air / oxygen for a shorter time than prescribed.

[0290] Figure 5AA system 8000 is described for detecting and / or communicating deviations of interface 3800, for assessing / analyzing therapy, or for assessing patient respiration. System 8000 may include an RT device 4000 and a patient interface 3800 (or an alternative patient interface). Figure 5B Further details of the patient interface 3800 are shown. The system 8000 may also optionally include an external device 8030.

[0291] like Figure 5A As shown, one or more of the patient interface 3800 or RT device 4000 may include one or more sensors 8010 or another type of transducer, such as any transducer discussed above for the RT device 4000. For example, the RT device 4000 may include a flow sensor, such as flow sensor 4274, which may be positioned upstream of blower 4142. Additionally or alternatively, the RT device 4000 may include an atmospheric pressure sensor, which may be used, for example, to correct for changes in air density with altitude and to improve the accuracy of the estimated PEEP. Sensor 8010 in Figure 5A The sensor 8010 is shown in dashed lines because it may be located in only one or the other of the patient interface 3800 or the RT device 4000 (or not in either of them). In some examples, the sensor 8010 may include a pressure sensor. Alternatively or additionally, the sensor 8010 may include any other suitable type of sensor. For example, some types of sensors 8010 may measure or detect respiration (e.g., via a pressure sensor, a temperature sensor (e.g., a thermocouple), a humidity sensor, or a carbon dioxide concentration monitor). Other types of sensors may measure, for example, the proximity of the patient interface 3800 to the patient's anatomy (e.g., the nostrils) (e.g., a light sensor / emitter, a temperature sensor, or a sensor for measuring impedance, capacitive touch, or resistive touch). Other types of sensors may also be used as, for example, secondary sensors (e.g., accelerometers, orientation sensors, pulse oximeters, or inertial measurement units (“IMUs”). If sensor 8010 is disposed in / located at RT device 4000, sensor 8010 may have any of the characteristics of pressure sensor 4272 or any other sensor discussed above. In some examples, sensor 8010 may be located at or near the outlet of blower 4142 (e.g., upstream of humidifier 5000), at or near the outlet of humidifier 5000, upstream of blower 4142, at or near the inlet of patient interface 3800, or any other suitable location.

[0292] like Figure 5BAs shown, the patient interface 3800 may include a conduit 3830 extending from lumens 3820a, 3820b to the RT device 4000. This conduit may be an example of an air circuit 4170. The conduit 3830 may connect to lumens 3820a, 3820b at the interface 3840. The conduit 3830 may be connected to the RT device 4000 via a connector 3850, such that the patient interface 3800 is in fluid communication with the outlet of the RT device 4000. Air and / or oxygen may flow along the flow path through the RT device 4000, the conduit 3830, and the patient interface 3800. In some aspects, the conduit 3830 may be heated. The conduit 3830 may have different dimensions.

[0293] like Figure 5B As shown, in some examples, sensor 8010 may be located at interface 3480. However, such a location is merely exemplary. Additionally or alternatively, sensor 8010 may be located in / on one or more of lumens 3820a, 3820b and / or one or more of forks 3810a, 3810b. Additionally or alternatively, sensor 8010 may be located in or on a bridging portion 3860 extending between forks 3810a, 3810b, at connector 3850, or along the length of conduit 3830. In addition to or instead of sensor 8010, patient interface 3800 may also include sensor 8020. Figure 5B As shown, sensor 8020 may be disposed in or on one or both of fork tubes 3810a and 3810b. Alternatively or additionally, sensor 8020 may be disposed at any of the locations discussed above with respect to sensor 8010. Sensor 8020 may be a sensor of the same type as sensor 8010, or may be a sensor of a different type. Sensor 8020 may be any type of sensor, including but not limited to the sensor types listed above for sensor 8010.

[0294] like Figure 5AAs shown, external device 8030 may include sensor 8040, which may have any of the characteristics of sensors 8010 and 8020. In one example, external device 8030 may include a device for attachment to a patient, and sensor 8040 may include a pulse oximeter. For example, external device 8030 may include a clip or strap for attachment to a finger of patient 1000. Alternatively, external device 8030 and sensor 8040 may be configured to measure alternative characteristics of patient 1000 (e.g., heart rate, respiratory rate, blood pressure, movement, etc.). The external device may include a strap (e.g., a wristband or chest strap, electrodes, or a smartphone). Alternatively, external device 8030 may be located in a room, and sensor 8040 may be configured to measure room conditions. In another alternative, external device 8030 may be associated with another medical device (e.g., a medical device for delivering treatment or performing diagnosis).

[0295] 5.4.3.5.2 Methods for detecting interface parameters

[0296] Pressure measurements can be used to determine flow parameters for therapy delivered to patient 1000. For example, U.S. Patent Application Publication No. 2022 / 0160979, published May 26, 2022, which is incorporated herein by reference in its entirety, discloses a system and method for estimating outlet pressure (e.g., pressure drop across the air circuit and patient interface 3800), respiratory flow, and connection parameters. U.S. Patent Application Publication No. 2022 / 0160979 also discloses that outlet pressure, flushing flow, and respiratory flow can be used to output one or more therapy parameters for use by RT device 4000. U.S. Patent Application Publication No. 2022 / 0160979 also discloses that certain parameters are reported by a central controller 4230. U.S. Patent Application Publication No. 2022 / 0160979 also includes other relevant disclosures not specifically identified above but related to this disclosure. The methods described herein are not mutually exclusive. The steps of the methods can be combined in any suitable manner, and steps can be omitted or repeated as needed.

[0297] Figure 6A A flowchart of an exemplary method 9000 for detecting one or more interface parameters is depicted. In step 9010, data may be received (e.g., by a central controller 4230) from one or more of sensors 8010, 8020, and 8040. Although the central controller 4230 is referred to herein as performing the steps of method 9000, it should be understood that alternative local or remote controllers of the RT device 4000 (such as a remote external device 4286 (e.g., a cloud-based controller)) may perform one or more steps of method 9000.

[0298] In one example, the data could reflect the pressure at one or more locations of the RT device 4000, one or more locations along the air circuit 4170 (e.g., along pipe 3830), one or more locations within the patient interface 3800, or at the outlet of the fork pipes 3810a, 3810b of the patient interface 3800. For example, as Figure 5B As shown, sensor 8010 can measure pressure at interface 3840, where patient interface 3800 and conduit 3830 are connected to each other. In additional or alternative examples, sensor 8010 can measure pressure downstream of humidifier 5000, at or near the outlet of blower 4142, at or near the inlet of patient interface 3800, or at any other suitable location.

[0299] In step 9020, the central controller 4230 can use the data received in step 9010 to analyze / determine whether the patient interface 3800 is completely misaligned or displaced. For example, the central controller 4230 can compare the measured pressure to a threshold or threshold range. This threshold can indicate the value expected to be measured by one or more sensors 8010 when the patient interface is correctly positioned. This threshold can depend at least in part on the settings of the RT device 4000 at the time (e.g., airflow settings, humidity settings, the amount of oxygen being delivered (e.g., a mixture of air and oxygen), the size or type of the patient interface being worn, or other variables. Therefore, if the measured pressure differs sufficiently from the threshold, the comparison of the measured pressure to the threshold may indicate misalignment. In some aspects, the degree to which the measured pressure differs from the threshold may be related to the degree and / or manner of misalignment of the patient interface 3800.

[0300] Typically, the pressure of the air and / or oxygen flow after the humidifier 5000 will be lower than the pressure at the outlet of the blower 4142, and will decrease again after passing through the duct 3830 (e.g., at the interface 3840). Outside the bifurcations 3810a and 3810b, this pressure generally matches the pressure inside the patient's nostrils. The air and / or oxygen flow rates through the bifurcations 3810a and 3810b can be high enough compared to ambient pressure to increase the pressure in the nostrils. The pressure drop between each consecutive location along the air / oxygen flow rate can be characterized by the following equation: Pressure Drop = A * Flow Rate + B * Flow Rate 2The pressure drop is measured in cmH2O, and the flow rate is measured in L / s. Coefficient "A" is attributed to frictional losses (laminar resistance), which is proportional to the flow rate. Coefficient "B" is attributed to turbulent resistance (i.e., Bernoulli's equation), where the pressure drop is proportional to the square of the flow rate. These coefficients can be empirically determined by fitting curves to flow rate versus pressure plots at the inlet of the air delivery hose upstream of the patient interface 3800 and the air delivery hose. In some examples, the pressure sensor may be placed at multiple locations. For example, the pressure sensor may be located before and after a continuous flow segment.

[0301] These coefficients can vary depending on the different configurations of the RT device 4000, humidifier 5000, air circuit 4170 (e.g., duct 3830), and / or patient interface 3800. For example, the patient interface can have multiple sizes (e.g., small, medium, large), or the air circuit 4170 can have different lengths and / or diameters. The humidifier 5000 can be included in the same model as the RT device 4000 (described above), or it can be modeled separately as a series component. U.S. Patent Application Publication No. 2004 / 0074495, published April 22, 2004, further describes the calculation of pressure drop, which is incorporated herein by reference in its entirety. In some aspects, the impedance of the nasal cannula-type unsealed patient interface 3800 can dominate the impedance of the air delivery hose.

[0302] As discussed above, memory 4260 (or other storage device) may store thresholds or threshold ranges thereon. For example, the threshold could be the expected reading of sensor 8010 when it is correctly positioned in the nostril of patient 1000. This threshold can vary based on, for example, the positioning of pressure sensor 8010 within system 8000. This threshold can explain the pressure drop described above as air and / or oxygen pass through RT device 4000, air circuit 4170, and patient interface 3800. For example, if the pressure reading from sensor 8010 is higher / lower than this threshold, central controller 4230 can determine that patient interface 3800 is not correctly positioned in the patient's nostril. Certain values ​​from the pressure sensor 8010 reading (e.g., values ​​indicating that fork tubes 3810a / 3810b flow into the room rather than into the nostrils of patient 1000) can indicate that the patient interface is completely displaced from the face of patient 1000. Other values ​​can indicate that the patient interface is partially displaced from the face of patient 1000.

[0303] In some respects, the threshold used can be adjustable / customizable. For example, the threshold can be set for a specific patent to determine only when the patient interface 3800 is completely detached from the patient 1000's face. Alternatively, the threshold can be set to determine when the patient interface 3800 is slightly off-center, moderately off-center, etc.

[0304] Readings obtained from multiple pressure sensors 8010, 8020, 8040 can be acquired and combined, compared, correlated, filtered, or otherwise analyzed during step 9020. For example, multiple sensors of the same type (e.g., multiple sensors 8010) can be located at different locations, such as in the RT device 3000, patient interface 3800, or air circuit 4170. Alternatively or additionally, various types of sensors can be used. Readings from these different sensors can be combined, synthesized, filtered, or otherwise analyzed or calibrated. For example, stored thresholds (e.g., numerical values, ranges, waveforms, etc.) can interpret readings from multiple sensors, or readings from multiple sensors can be calibrated before comparison with such thresholds.

[0305] Step 9020 may further include: interpreting the respiratory cycle of patient 1000. At some points during the respiratory cycle of patient 1000 (e.g., expiration), the pressure drop may be small. At other points, such as during inspiration, the pressure drop may be large. The central controller 4230 may be programmed to determine at which point during the respiratory cycle a measurement is obtained from sensor 8010. Additionally or alternatively, step 9010 may include: obtaining multiple measurements from sensor 8010; and step 9020 may include: synthesizing the multiple measurements to interpret the respiratory cycle. Additionally or alternatively, step 9020 may include: filtering the data received in step 9010 to interpret the respiratory cycle / breathing pattern of patient 1000. In addition, step 9020 may include one or more of the following: compensation for the nasal cycle; whether patient 1000 is sedentary, active, or sleeping; the prognosis of patient 1000; the patient 1000's position (e.g., sitting, lying down, standing, moving); whether patient 1000 is speaking, coughing, eating, drinking; or performing other actions with the mouth or nose. See below for method 9100 (…). Figure 6C As discussed in further detail, various aspects of patient respiration (e.g., the respiratory cycles of patient 1000) can be used to calibrate thresholds or adjust the analysis of the measurements received in step 9010.

[0306] Additionally or alternatively, step 9020 may include comparing the respiratory waveform with an expected threshold respiratory waveform. For example, a typical respiratory waveform might look like this: Figure 7A The waveform.

[0307] Figure 7B An exemplary waveform of pressure versus time measured during the respiratory cycle is shown. During the exhalation time (T... e During the inhalation time (T), the pressure measured by the sensor can be higher than during the inhalation time (T). iThe pressure measured during the period. If the patient interface 3800 is slightly or moderately off-center, the amplitude, period / frequency, periodicity, slope, component waveforms, or other aspects of the patient's respiratory waveform may differ from the expected waveform and / or the measured pressure plot. For example, if the patient interface 3800 is off-center, the pressure versus time plot (such as...) Figure 7B (As shown) can have an amplitude lower than 3800 when the patient interface is correctly positioned (corresponding to the maximum pressure (P)). max ) and / or minimum pressure (P min If the patient interface 3800 is disconnected from the patient, the pressure-time graph may be a horizontal straight line. As used herein, the term "threshold" may encompass at least a single threshold, a threshold range, an expected / threshold respiratory waveform, a graph, and / or a pattern. For example, a threshold may include the amplitude of the pressure waveform, such as... Figure 7B As shown. Step 9020 may include comparing a pressure waveform representing pressure data from sensor 8010 (and / or other sensors, such as sensors 8020, 8040) with a threshold. In some examples, the threshold may be a threshold amplitude, and the comparison may be a comparison between the amplitude of the threshold waveform associated with the received data and the threshold amplitude. If the patient interface 3800 is off-center, the amplitude of the pressure waveform received from sensors 8010, 8020, and / or 8040 may be lower than the threshold. The amplitude of the pressure waveform may be the average amplitude over multiple respiratory cycles, or it may be obtained from a single respiratory cycle. This amplitude can be determined based on the maximum pressure P. max Minimum pressure P min or P max and P min The combination of values ​​determines the outcome.

[0308] Variations in the amplitude, period / frequency, periodicity, slope, component waveforms, or other aspects of a patient's respiratory waveform may occur normally from one breath to another. The comparison in step 9020 can interpret natural variations in individual respiration and can compare general trends associated with the rising and falling patterns of respiration. In the example above, the general amplitude trend of the rising and falling patterns of patient respiration can be used as an indicator of the positioning of the patient interface 3800. In some respects, certain patterns of the waveform can be used to refine the detection of the positioning of the patient interface 3800.

[0309] In step 9030, upon determining that the patient interface 3800 has deviated from the desired position (e.g., based on the comparison in step 9020), an alert may be provided to the patient 1000 and / or the medical / healthcare provider. For example, output device 4290 may provide such an alert. The alert may be visual, auditory, tactile, or a combination thereof. The alert may, for example, remind the patient 1000 that the patient interface 3800 has deviated from its position and needs to be properly worn. The alert may be qualitative (e.g., informing the patient 1000 that the patient interface 3800 is not properly positioned and needs repositioning, e.g., in a specific manner), or may include lights, sounds, vibrations, or text messages. The alert may provide different warning signals depending on the positioning problem and / or the action the patient needs to take, or it may provide the same warning signal regardless of the positioning problem and / or the action required. Additionally or alternatively, the alert may be sent to a remote device via data communication interface 4280. For example, the alert may be sent to the patient's device (such as a computer or smartphone) or to the healthcare provider's device. In various aspects, step 9030 may include: displaying a dashboard to a healthcare provider (e.g., a doctor, nurse, therapist, etc.), which may, for example, provide the provider with a point of contact. Step 9030 may also include: transmitting reports on positioning over time. For example, such reports may indicate the percentage of time the patient interface 3800 is properly positioned, and / or pattern analysis related to the positioning of the patient interface 3800 (e.g., time of day, patient position, patient activity level, etc.). Step 9030 may also include: comparing the positioning data of the patient interface 3800 with the prescribed usage of the RT device 4000 and the patient interface 3800. The data obtained in step 9010 may be timestamped, and the reports may provide detailed feedback on patient compliance, the positioning of the patient interface 3800, the patient's breathing patterns, etc.

[0310] In step 9030, if a respiratory deterioration is detected exceeding the indication requiring adjustment, an alarm may instruct the patient to consult a doctor, go to a hospital, contact a healthcare provider or other party, call for emergency assistance, or otherwise convey the patient's need for medical assistance. Additionally or alternatively, system 8000 may automatically dial an emergency number, contact a doctor or designated emergency contact, or otherwise take automated actions.

[0311] The discussion above includes the data being collected from sensor 8010, which is an example of a pressure sensor. Method 9000 may also include collecting data from other sensors (such as sensor 8020) (further details regarding the use of sensor 3840 are provided below). Sensor 8020 may also be a pressure sensor. Alternatively, sensor 8020 may be a different type of sensor. For example, sensor 8020 may be a light sensor positioned on the fork tube 3810b, such as... Figure 5B As shown. A light emitter (not shown) can be positioned on another fork tube 3810a. The light sensor can determine whether the fork tubes 3810a, 3810b are positioned in the nostrils based on the amount of light measured by sensor 8020. For example, if the amount of light measured by sensor 8020 exceeds a threshold, then in step 9020, the central controller 4230 can determine that the fork tubes 3810a, 3810b are not correctly positioned in the nostrils of patient 1000. Additionally or alternatively, the light emitter can transmit light through tissue, and sensor 8020 can measure / detect the heart pulse based on light absorption to determine whether the fork tubes 3810a, 3810b are correctly positioned or to determine other aspects of treatment delivery, efficacy, etc. In other alternatives, sensor 8020 can measure other parameters (e.g., temperature, humidity, location, flow rate, etc.) that can indicate whether the patient interface 3800 is correctly positioned.

[0312] The steps of method 9000 may be repeated periodically (e.g., at set intervals), irregularly, continuously, after a certain stage of treatment, at a certain time during treatment, or after a patient adjustment (e.g., checking whether an adjustment has been made due to misalignment of the patient interface 3800). Step 9030 may include providing one or more progress reports showing how the positioning of the patient interface 3800 changes over time (e.g., in minutes, hours, days, weeks, months, or years).

[0313] Figure 6BAnother method 9050 is described, which allows control of the RT device 4000. Method 9050 can utilize any step of method 9000, as described above. In step 9060, the central controller 4230 can receive data from one or more sensors. Step 9060 may include receiving any data described above. Additionally, step 9060 may include receiving data from sensor 8040 of external device 8030. Sensor 8040 may include sensors that acquire data indicating the effectiveness of treatment administered by the RT device 4000. In one example, sensor 8040 may be a pulse oximeter configured to measure the blood oxygen saturation of patient 1000. Alternatively, sensor 8040 may be configured to measure patient movement (e.g., sensor 8040 may include an IMU, accelerometer, position sensor, heart rate sensor, etc.). In some aspects, a decrease in the activity level of patient 1000 may indicate a decrease in the effectiveness of treatment. Sensor 8040 may alternatively measure other types of data.

[0314] In step 9070, the central controller 4230 may evaluate / analyze the effectiveness of treatment using the RT device 4000. Step 9070 may include determining whether data from sensor 8040 indicates sufficient efficacy of the therapy (e.g., by comparing data from sensor 8040 to a threshold (e.g., a threshold, a threshold range, or a threshold waveform)). Step 9070 may include some or all of the analysis of the method 9000 discussed above. For example, step 9070 may interpret the duration for which the patient interface 3800 is properly positioned. If the central controller 4230 determines that the patient interface 3800 is properly positioned for an acceptable duration (e.g., above a threshold for duration or percentage of time), and the therapy is not sufficiently effective (e.g., because data from sensor 8040 is above / below a threshold), then step 9070 may determine that the prescribed therapy is inadequate. In other words, the central controller 4230 may determine that, despite patient interface 3800 being compliant and correctly positioned, the prescribed therapy is not providing the expected results. Alternatively, if step 9070 determines that the patient interface 3800 has not been correctly positioned for a sufficient duration (e.g., misaligned for too long a time or a percentage of the time), step 9070 may determine that the efficacy of the prescribed therapy cannot be evaluated. The output device 4290 (or other device) or a healthcare professional may notify the patient 1000 that the patient interface 3800 is not being worn correctly and may instruct the patient 1000 to wear it correctly (or a different patient interface 3000 or 3800 may be specified). In another alternative, the central controller 4230 may determine that adjustments to the therapy can compensate for improper positioning of the patient interface 3800.

[0315] Based on the above, in step 9080, the central controller 4230 can determine whether adjustments to the prescribed therapy are needed. For example, in step 9080, the central controller 4230 can determine, based on analysis of data from sensors 8040 and / or 8010, 8020, that adjustments are needed to the flow rate of air and / or oxygen, the amount of oxygen delivered (e.g., an air / oxygen mixture), the duration of wear of the patient interface, the type of wear of the patient interface, the size of the patient interface, etc., to address any lack of efficacy. Alternatively or additionally, the central controller 4230 can notify the healthcare provider of this analysis. In some aspects, step 9080 may include: determining the adjustments to be made.

[0316] If adjustments are required, in step 9090, parameters of the therapy can be adjusted based on the analysis of steps 9070 and / or 9080 (e.g., using the therapy device controller 4240). For example, the flow rate or the amount of oxygen delivered (e.g., an air / oxygen mixture) can be changed. Based on the analysis of steps 9070 and / or 9080, step 9090 can be performed automatically, causing system 8000 to form a closed-loop system. Alternatively, step 9090 can be performed manually, for example, by the patient or healthcare provider. Alternatively, if it is determined in step 9080 that no adjustments are required, method 9050 can terminate in step 9095. The steps of method 9050 can be repeated periodically (e.g., at set intervals), continuously, irregularly, after a certain phase of treatment, at a certain time during treatment, or after the patient adjusts the treatment (e.g., checking whether the adjustment made is a result of a misalignment of the patient interface 3800). In some respects, if an adjustment is determined in step 9080, for example, to assess whether the determined adjustment works, the steps of method 9050 can be performed more frequently.

[0317] As discussed above regarding step 9030, step 9090 may further include: if the patient's breathing deteriorates to a specified degree (e.g., exceeding a threshold), alerting the patient to seek medical care or automatically contacting a doctor or other party for medical assistance.

[0318] The thresholds (e.g., numerical values, ranges, or waveforms) used in steps 9020 and 9070 can be patient-specific. For example, Figure 6CMethod 9100 includes step 9110: receiving baseline data and / or previous patient history data of patient 1000 from one or more of sensors 8010, 8020, 8040 (or other sensors). This baseline data may be obtained when patient 1000 is breathing normally, or from a long-term average expected to reflect normal breathing. In the example, this baseline data may be obtained when patient interface 3800 is correctly / ideally positioned. Additional baseline data may be obtained when patient interface 3800 deviates from its position in one or more configurations (e.g., baseline data may be obtained for different types and degrees of positioning errors). In some aspects, this type of data may be initially acquired when setting up a patient using RT device 4000. During data acquisition in step 9110, RT device 4000 may perform a specific set of actions to acquire the desired data. For example, memory 4260 may store a data acquisition / calibration protocol to be executed by central controller 4230. For example, the RT device 4000 can deliver air and / or oxygen under different parameters (e.g., different flow rates, different air / oxygen mixtures, etc.) and can acquire data from sensors 8010, 8020, and 8040 under different parameters. In step 9110, data about the environment can also be acquired. For example, data about the patient's location can be acquired, including weather conditions, altitude, ambient pressure, or pollution levels at that location.

[0319] In step 9120, the baseline data acquired in step 9110 can be used to generate patient-specific thresholds (e.g., numerical values, ranges, patterns, graphs, and / or waveforms). These thresholds can be any type of threshold discussed above in methods 9000 and 9050. For example, the threshold could be a pressure threshold indicating the pressure at an ideal location on the patient interface 3800, as well as various pressures with different positioning errors. Additionally or alternatively, other types of thresholds or patterns (e.g., breathing patterns, variations between inhalation and exhalation, etc.) can be generated. For example, typical baseline respiratory rate, inhalation / exhalation volume, or other parameters can be acquired. Curves / graphs / waveforms reflecting the patient's baseline breathing pattern can be generated.

[0320] In step 9130, the threshold and / or pattern generated in step 9120 can be stored, for example, in memory 4260. The stored threshold and / or pattern can be used, for example, in steps 9020, 1970, and / or 9080 of methods 9000 and / or 9050.

[0321] In some examples, method 9100 may be repeated periodically (e.g., during regular wear by patient 1000 or after prompting patient 1000 to begin the calibration process). The patient interface on RT device 4000 or other devices may prompt patient 1000 to position patient interface 3800 in a specific manner and / or perform certain steps on the RT device or other interface. When method 9100 is performed / repeated, the user interface may prompt patient 1000 to input data (e.g., how bad / good the patient feels, whether the patient has a respiratory infection or allergies, whether the patient smokes, environmental details, etc.). In this way, the obtained baseline information is calibrated at least in part based on other factors that may affect the patient's breathing and therefore information detected by one or more sensors.

[0322] In some examples, machine learning can be used to perform step 9120. For instance, population-based data or patient-specific data (or a combination thereof) can be used to train the machine learning model. Step 9110 can be repeated at a later date, and the trained machine learning model can be used to update the threshold / pattern in step 9120. In some respects, machine learning algorithms can be used over time to develop models of the breathing patterns / features of patient 1000. Machine learning algorithms can also be used to characterize the breathing of patient 1000 under different conditions (e.g., when the patient has a respiratory infection or allergies, when weather conditions change, when pollution is better / worse, when at different altitudes, etc.).

[0323] Figure 6D An exemplary method 9200 is depicted using a patient-specific threshold generated in method 9100. Methods 9000 and 9050 may also use patient-specific thresholds (e.g., in steps 9020, 9070, and 9080). Specifically, any aspect of step 9220 described below may be used in steps 9020, 9070, and 9080.

[0324] In step 9210, data may be received from one or more sensors 8010, 8020, 8040. Step 9210 may include any aspect of the various aspects of steps 9010, 9060, 9110 described above.

[0325] In step 9220, the data obtained in step 9210 may be compared with patient-specific thresholds generated in method 9100 to characterize / analyze the location (e.g., correct or incorrect location) of patient interface 3800. Additionally or alternatively, the data obtained in step 9210 may be compared with thresholds and / or other data (e.g., curves or graphs of patient 1000's breathing) regarding various aspects of patient 1000's breathing. The analysis in step 9220 may be used to characterize various aspects of patient 1000's breathing. For example, the analysis in step 9220 may be used to assess whether patient 1000 has an obstruction, is coughing (characterized as a brief, impulsive burst), is smoking, or is in an environment with specific temperature, humidity, pollution levels, altitude, or other quality. The analysis may also determine patient 1000's location or characterize the progression (or lack thereof) of patient 1000's disease. Step 9220 may also include evaluating the therapy being administered, as described in step 9070 or method 9050.

[0326] In step 9230, an alert or other update may be provided to patient 1000 or a healthcare provider. Such an alert or update may be provided when it is determined that it is needed. As discussed above, the alert or information may be provided in any suitable manner (e.g., via auditory or visual signals, via text on a user interface, or via a provider dashboard). Additionally or alternatively, the analysis may be used to adjust the therapy, as described in steps 9080 and 9090 of method 9050. As discussed above, regarding step 9030, step 9230 may include: notifying patient 1000 to obtain healthcare assistance if breathing deteriorates to a defined degree, and / or automatically notifying a physician or emergency medical personnel.

[0327] The methods described above can be performed at any suitable interval. For example, methods 9000 and 9200 can be performed at short intervals (e.g., continuously or almost continuously). Alternatively, longer intervals can be used. The length of the interval can be customized for a specific patient 1000 and / or the length of the interval can vary based on any suitable variable (e.g., time of day, location of patient 1000, parameters of the therapy being administered, patient 1000's position, or any other relevant parameter). One or more of methods 9000, 9050, 9100, or 9200 can be performed independently of each other or in combination with each other.

[0328] 5.5 Air Circuit

[0329] According to one aspect of the technology, the air circuit 4170 is a conduit or tube that is constructed and arranged to allow airflow to travel between two components (such as the RT device 4000 and the patient interface 3000 or 3800) during use.

[0330] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block 4020. This air circuit may be referred to as an air delivery tube. In some cases, separate branches for inhalation and exhalation may exist in the circuit. In other cases, a single branch is used.

[0331] In some forms, air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or raise the temperature of the air. The heating elements may be in the form of a heating wire loop and may include one or more transducers, such as temperature sensors. In one form, the heating wire loop may be helically wound around an axis of air circuit 4170. The heating elements may be communicated with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0332] 5.5.1 Supplemental Gas Delivery

[0333] In one form of the technology, supplemental gas (e.g., oxygen) 4180 is delivered to one or more points in the pneumatic path (such as upstream of pneumatic block 4020), air circuit 4170 and / or patient interface 3000 or 3800.

[0334] 5.6 Respiratory waveform

[0335] Figure 7 shows a typical respiratory waveform of a person during sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow. Although parameter values ​​can vary, typical breathing may have the following approximations: 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, and peak expiratory flow rate Qpeak – 0.5 L / s. The total duration of breathing Ttot is approximately 4 s. A person typically breathes at a rate of approximately 15 breaths per minute (BPM), with a tidal volume Vent of approximately 7.5 L / min. The typical duty cycle (the ratio of Ti to Ttot) is approximately 40%.

[0336] 5.7 Breathing Therapy Mode

[0337] Various breathing therapy modalities can be implemented through the publicly available breathing therapy system.

[0338] 5.7.1 High-flow therapy

[0339] In other forms of respiratory therapy, the pressure of the airflow is not controlled as in respiratory pressure therapy. Instead, a central controller 4230 controls a pressure generator 4140 to deliver an airflow at a device flow rate Qd controlled as a therapeutic flow rate or target flow rate Qtgt, which is typically positive throughout the patient's respiratory cycle. Such forms are often grouped under the heading of flow therapy. In flow therapy, the therapeutic flow rate Qtgt can be a constant value, either hard-coded or manually entered into the RT device 4000. If the therapeutic flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, the therapy is often referred to as high-flow therapy (HFT). Alternatively, the therapeutic flow rate can be a curve Qtgt(t) that varies with the respiratory cycle.

[0340] 5.8 Glossary

[0341] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. In other forms of this technology, alternative definitions may be applied.

[0342] 5.8.1 General Terminology

[0343] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0344] Environment: In some forms of this technology, the term environment is considered to mean (i) the exterior of the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0345] For example, the environment relative to a humidifier humidity This could be the humidity of the air directly surrounding the humidifier, such as the humidity in the patient's bedroom. This type of ambient humidity can differ from the humidity outside the patient's bedroom.

[0346] In another example, environmental stress can be stress that is either close to the body or outside the body.

[0347] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the room where the patient is located, rather than noise generated by, for example, the RT device or emitted from the mask or patient interface. Ambient noise may be generated by sources outside the room.

[0348] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum (e.g., varying with each breath) depending on the presence of an indication of an SDB event.

[0349] Continuous positive airway pressure (CPAP) therapy: a respiratory pressure therapy in which the treatment pressure remains substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between the patient's different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when no indication of partial upper airway obstruction is detected.

[0350] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate will be a scalar quantity, that is, a quantity that only has magnitude. In other cases, a reference to flow rate will be a vector quantity, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. "Flow rate" is sometimes simply abbreviated as "flow" or "airflow".

[0351] In the example of patient breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air leaving the RT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the flow rate of air leaving the vent to allow flushing of exhaled gas. Leakage flow rate Ql is the flow rate leaking from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received from the patient's respiratory system.

[0352] Flow therapy: This includes respiratory therapy that delivers a flow of air to the inlet of the airway at a controlled flow rate known as the therapeutic flow rate, which is generally positive throughout the patient’s respiratory cycle.

[0353] Humidifier: The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or has a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to alleviate a patient’s medical respiratory symptoms.

[0354] Leakage: The term "leakage" will be considered as an unintended flow of air. In one example, a leak might occur due to an incomplete seal between the mask and the patient's face. In another example, a leak might occur in a swivel bend leading to the environment.

[0355] Conducted noise (acoustic): In this document, conducted noise refers to noise transmitted to the patient through pneumatic paths, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0356] Radiated noise (acoustics): In this document, radiated noise refers to noise transmitted to the patient by ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object under discussion.

[0357] Vent noise (acoustic): Vent noise in this document refers to the noise generated by the airflow through any vent (such as the vent hole of a patient interface).

[0358] Oxygen-enriched air: Air with an oxygen concentration greater than that of atmospheric air (21%), for example, at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen-enriched air” is sometimes abbreviated as “oxygen”.

[0359] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0360] Patient: A person, regardless of whether they have a respiratory illness.

[0361] Pressure: Force per unit area. Pressure can be expressed in units, including cmH2O and gf / cm². 2 And 1000 pascals. 1 cmH2O equals 1 g-f / cm 2 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 = 1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0362] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0363] Respiratory pressure therapy: Applying an air supply to the airway entrance at a therapeutic pressure that is normally positive relative to the atmosphere.

[0364] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0365] 5.8.2 Respiratory cycle

[0366] Apnea: According to some definitions, apnea is considered to have occurred when airflow drops below a predetermined threshold for a sustained period (e.g., 10 seconds). Obstructive apnea is considered to occur when, despite the patient's efforts, some form of airway obstruction prevents airflow. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with an obstructed airway.

[0367] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured as the number of breaths per minute.

[0368] Duty cycle: The ratio of inhalation time Ti to total respiratory time Ttot.

[0369] Effort (breathing): The work that a person who breathes spontaneously tries to do while breathing.

[0370] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0371] Flow restriction: Flow restriction is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. If flow restriction occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow restriction. If flow restriction occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow restriction.

[0372] Types of flow-limited inhalation waveforms:

[0373] (i) Flat-top shape: It rises first, followed by a relatively flat section, and then falls.

[0374] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0375] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0376] (iv) Inverted chair shape: has a relatively flat section followed by a single local peak at the trailing edge.

[0377] Insufficient breathing: Under certain conditions, insufficient breathing is considered a reduction in flow, not an interruption of flow. In one form, insufficient breathing is considered to have occurred when the flow rate drops below a threshold rate for a sustained period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to reduced respiratory effort. In one form in adults, any of the following can be considered insufficient breathing:

[0378] (i) The patient's breathing decreases by 30% for at least 10 seconds, plus an associated 4% desaturation; or

[0379] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% associated desaturation or arousal.

[0380] Hyperventilation: The flow rate increases to a level higher than normal.

[0381] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0382] Airway patency: The degree to which the airway is open or the extent to which the airway is open. A patent airway is open. Airway patency can be quantified, for example, a value of one (1) indicates patentness, and a value of zero (0) indicates closure (obstruction).

[0383] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.

[0384] Peak flow (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0385] Respiratory flow, patient airflow, and respiratory airflow rate (Qr): These terms can be understood as estimates of the respiratory flow rate of the RT device, as opposed to “true respiratory flow rate,” which is the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.

[0386] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) equals the expiratory volume Ve (the volume of air exhaled), and therefore a single tidal volume Vt can be defined as equal to either volume. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0387] Inhalation time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0388] Exhalation time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0389] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.

[0390] Typical recent ventilation: Vent values ​​tend to cluster around their recent values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0391] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or may even decrease as the pressure differential across the upper airway increases (Starling resistance behavior).

[0392] Ventilation: A measurement of the total amount of gas exchanged by a patient's respiratory system. Ventilation can be measured by one or both of inspiratory flow rate and expiratory flow rate (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and is understood as volume per minute.

[0393] 5.9 Other Remarks

[0394] This patent document contains a portion of copyrighted material. The copyright holder does not object to any fax copying of the patent document or patent disclosure appearing in the patent office's patent documents or records, but otherwise reserves all copyright rights.

[0395] Unless the context clearly indicates otherwise and a range of values ​​is provided, it should be understood that every intermediate value (to one-tenth of the lower limit unit) between the upper and lower limits of the range, as well as any other said or intermediate values ​​within the range, are covered by this technique. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also covered by this technique, but are subject to any explicit exclusions within the range. Where the range includes one or both of these limitations, the range excluding any one or both of those included limitations is also included in this technique.

[0396] Furthermore, where one or more values ​​described herein are implemented as part of this technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used for any suitable significant number to the extent that the actual technical implementation may allow or require.

[0397] Furthermore, as used herein, “approximately,” “substantially,” “about,” or any similar terms mean + / - 5-10% of the stated values.

[0398] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0399] When a particular material is identified for use in constructing a component, an obvious alternative material with similar properties may be used as a substitute. Furthermore, unless otherwise stated, any and all components described herein should be understood as capable of being manufactured, and therefore can be manufactured together or separately.

[0400] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.

[0401] All publications mentioned herein are incorporated in their entirety by reference to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology is not entitled to any prior disclosure by virtue of a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0402] The terms “comprising” and “including” should be interpreted as referring to an element, component or step in a non-exclusive manner, indicating that the referenced element, component or step may be present, used or combined with other elements, components or steps not expressly referenced.

[0403] The headings used in the detailed embodiments are for convenience of the reader only and should not be used to limit the subject matter found throughout this disclosure or the claims. The headings should not be used to interpret the claims or to limit the scope of the claims.

[0404] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details that are not required for practicing the techniques. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but may be used to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such sequence is not required. Those skilled in the art will recognize that such sequence may be modified and / or its aspects may be performed concurrently or even simultaneously.

[0405] Therefore, it should be understood that numerous modifications can be made to the exemplary examples and other arrangements can be designed without departing from the spirit and scope of this technology.

[0406] 5.10 List of reference numerals

[0407]

[0408]

[0409]

Claims

1. A system for analyzing high-flow respiratory therapy, the system comprising: Blower; Nasal intubation, wherein during the administration of the high-flow respiratory therapy, airflow travels along a flow path from the blower to the nasal intubation; Sensors are disposed along the flow path; and A processor configured to perform the following steps: Receive data from the sensor; The data received from the sensor is compared with a threshold. Based at least in part on the comparison, determine whether the nasal cannula is misplaced or displaced from the patient; and When it is determined that the nasal cannula is misplaced or displaced from the patient, an alarm signal is sent, indicating that the nasal cannula is misplaced or displaced from the patient.

2. The system according to claim 1, wherein the processor and the blower are disposed within the respiratory therapy device.

3. The system according to any one of claims 1 or 2, the system further comprising a conduit connected to the nasal cannula at an interface, wherein the sensor is disposed at the interface.

4. The system of claim 3, wherein the sensor is a pressure sensor, and wherein the threshold is the amplitude of the pressure waveform.

5. The system according to any one of claims 1 to 4, wherein the threshold is a patient-specific threshold.

6. The system of claim 5, wherein the patient-specific threshold is based on analysis of data obtained from the sensor during calibration.

7. The system according to any one of claims 5 to 6, wherein the patient-specific threshold is generated based on machine learning.

8. The system according to any one of claims 1 to 7, wherein the sensor is a first sensor, and the system further includes a second sensor, the step further comprising: Receive data from the second sensor; as well as The efficacy of the respiratory therapy is evaluated, at least in part, based on data received from the second sensor.

9. The system according to any one of claims 1 to 8, wherein the alarm signal is sent to the patient.

10. The system according to any one of claims 1 to 9, wherein the alarm signal includes a report provided to a healthcare provider.

11. A system for analyzing high-flow respiratory therapy, the system comprising: Breathing therapy device; Nasal intubation; A conduit configured to connect to the nasal cannula at an interface, wherein during the administration of the high-flow respiratory therapy, airflow passes from the respiratory therapy device through the conduit and travels to the nasal cannula; A pressure sensor, wherein the pressure sensor is disposed in the nasal cannula, on the nasal cannula, or at the interface; and A processor configured to perform the following steps: Receive data from the pressure sensor; Analyze the data received from the pressure sensor; Based at least in part on the analysis, by comparing the amplitude of the pressure waveform of the received data with a threshold amplitude, it is determined whether the nasal cannula is misaligned or displaced from the patient; and When it is determined that the nasal cannula is misplaced or displaced from the patient, an alarm signal is sent, indicating that the nasal cannula is misplaced or displaced from the patient.

12. The system of claim 11, wherein the processor is disposed within the respiratory therapy device.

13. The system according to any one of claims 11 to 12, wherein the analysis comprises: The data received from the pressure sensor is compared with a patient-specific threshold.

14. The system of claim 13, wherein the patient-specific threshold is based on analysis of data obtained from the pressure sensor during calibration.

15. The system according to any one of claims 13 to 14, wherein the patient-specific threshold is generated based on machine learning.

16. The system according to any one of claims 11 to 15, wherein the system includes a second sensor, and the step further includes: Receive data from the second sensor; as well as The efficacy of the respiratory therapy from the respiratory therapy device is evaluated at least in part based on data received from the second sensor.

17. The system according to any one of claims 11 to 16, wherein the system includes a second sensor, and the second sensor is a sensor of a different type than the first sensor.

18. The system according to any one of claims 11 to 17, wherein the alarm signal is sent to the patient.

19. The system according to any one of claims 11 to 18, wherein the alarm signal includes a report provided to a healthcare provider.

20. A system for analyzing high-flow respiratory therapy, the system comprising: Blower; Nasal intubation, wherein during the administration of the high-flow respiratory therapy, airflow travels along a flow path from the blower to the nasal intubation; A pressure sensor is disposed along the flow path; and A processor configured to perform the following steps: Receive data from the pressure sensor; The amplitude of the pressure waveform from the data received from the pressure sensor is compared with a patient-specific threshold. Based on the comparison, the positioning of the nasal cannula or one aspect of the patient's breathing is analyzed. as well as When the analysis indicates that the nasal cannula is mispositioned or that there is a deviation in the patient's breathing, an alarm signal is sent to the patient based on the analysis.

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