A method for determining whether a high-flow therapy device is being used on a patient, a device for delivering high-flow therapy to a patient, and a high-flow therapy system.

Abstract

To provide improved medical devices or apparatus for the detection, diagnosis, treatment, prevention, etc. of respiratory-related diseases.SOLUTION: A method used in a regulator or the like associated with a respiratory therapy device may include determining whether a high flow therapy is being used by a patient and determining whether a property of a flow of air being delivered by a respiratory therapy device along an air circuit to an unsealed patient interface contains a significant oscillation within a breathing rate frequency band. The method may also include generating, dependent on the determination, a notification of whether high flow therapy is being used by the patient.SELECTED DRAWING: Figure 7a

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims the benefit of Australian Provisional Application No. 2015900 907, filed on 13 March 2015. The entire disclosure of the document is incorporated herein by reference for all purposes.

[0002] 2 Statement regarding federally - supported research or development Not applicable

[0003] 3 Name of the group for joint research and development Not applicable

[0004] 4 Sequence listing Not applicable

[0005] [Field of the Invention] This technology relates to one or more of the detection, diagnosis, treatment, avoidance and improvement of respiratory - related diseases. This technology also relates to medical devices or apparatuses or their uses.

Background Art

[0006] 5.2.1 The human respiratory system and its diseases The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway .

[0007] These airways include a series of branching tubes that become narrower, shorter and more numerous as they progress deeper into the lungs. The main function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, and these main bronchi further divide and ultimately become terminal bronchioles. The bronchi form the conducting airways and are not involved in gas exchange. When the airways further divide, respiratory bronchioles These become bronchi, and eventually alveoli. Gas exchange takes place in the alveolar region of the lungs. This is called the respiratory zone. See below: "Respiratory Physiol John B. West, Lippincott Willia ms & Wilkins, 9th edition published 2011 .

[0008] A certain range of respiratory diseases exist. Specific diseases have specific onsets (e.g., apnea, respiratory problems). It can be characterized by decreased inhalation and hyperventilation.

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB), and sleep It is characterized by the onset of symptoms such as obstruction or blockage of the airways during sleep. Normal deficiencies in muscle tone in the superior airway and tongue region, and combinations of the soft palate and posterior oropharynx wall. This is caused by [unspecified cause]. As a result of this condition, the patient's respiratory arrest typically lasts 30 to 120 seconds. During this time, breathing sometimes stops 200 to 300 times a night. As a result, daytime sleepiness occurs. When it becomes excessive, it can cause cardiovascular disease and brain injury. This symptom is a common condition. It is particularly common in overweight middle-aged men, but patients often have no noticeable symptoms. (USA 4,944,3) Please refer to issue 10 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a condition in which patients... This is a disease of the respiratory control system, characterized by alternating periods of increased and decreased ventilation known as the CSR cycle. These cycles repeat periodically. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. It can be caused. CSR may become harmful due to repeated exposure to low oxygen. Some patients wake up from sleep several times due to CSR, and insomnia worsens, sympathetic nerve activity increases, and afterload increases. See U.S. Patent No. 6,532,959 (Berthon-Jo nes).

[0011] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases with certain common characteristics. Such characteristics include increased resistance to airflow, increased expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD include emphysema and chronic bronchitis. The causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea during exertion, chronic cough, and sputum production.

[0012] To treat or improve such conditions, a range of treatments are used. Additionally, even otherwise healthy individuals can benefit from preventive treatment for respiratory diseases. However, there are several drawbacks to these.

[0013] 5.2.2 Respiratory Therapy Respiratory pressure therapy (e.g., nasal continuous positive airway pressure (CPAP) therapy) is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is, for example, that nasal continuous positive airway pressure therapy functions as an air splint by pushing the soft palate and tongue forward or backward against the posterior pharyngeal wall, thereby avoiding upper airway closure.

[0014] Compared with respiratory pressure therapy, in the case of high-flow therapy (HFT), a sealed patient interface Rather than depending on positive airway pressure delivered to the nose, it may depend on air delivery at the treatment flow rate near the patient airway inlet(s) through an unsealed patient interface that is largely open to the atmosphere. High-flow therapy is used in the treatment of OSA, CSR, and COPD. As a hypothesized mechanism of action, air delivered at high flow exits the patient's anatomic dead space, reducing the amount of rebreathing CO2, thereby increasing gas exchange efficiency. near the patient airway inlet(s) through an unsealed patient interface that is largely open to the atmosphere It may depend on air delivery at the treatment flow rate. High-flow therapy is used in the treatment of OSA, CSR, and COPD. As a hypothesized mechanism of action, air delivered at high flow exits the patient's anatomic dead space, reducing the amount of rebreathing CO2, thereby increasing gas exchange efficiency. As a hypothesized mechanism of action, air delivered at high flow exits the patient's anatomic dead space, reducing the amount of rebreathing CO2, thereby increasing gas exchange efficiency. exits the patient's anatomic dead space, reducing the amount of rebreathing CO2, thereby increasing gas exchange efficiency. thereby increasing gas exchange efficiency.

[0015] The range of high flow delivered is from about 0 to 120 liters per minute, preferably from about 0 to 75 liters per minute, more preferably from about 0 to about 5 0 liters per minute, and a preferred range is from about 10 to about 35 liters per minute.

[0016] The delivered air temperature can range from about 0°C to about 50°C, more preferably from about +4°C to about +45 °C, even more preferably up to room temperature of 40°C, and for providing comfort and effectiveness the most preferred range can be from 30°C to 37°C.

[0017] The relative humidity of the delivered air can be up to room humidity of 100% (e.g., in the range of about 50% to about 100% range or about 70% to about 100% range, or about 80% to about 95% range), and for providing comfort and effectiveness, a preferred range is 80% to 90%. The absolute humidity range is preferably from about 0 to about 82 mg / liter, or more preferably from about 27 to about 44 mg / liter.

[0018] Regarding high-flow therapy, on May 28, 2009, International Patent Application PCT / AU09 / 00 It is described in U.S. Patent Application Publication No. 2011-0253136, filed as 671. This specification references the entire document in question for informational purposes. High-flow therapy is used in conjunction with respiratory pressure therapy. It is possible.

[0019] 5.2.3 Treatment System Respiratory therapy can be provided by a therapy system or device. A therapy system provides respiratory therapy. RT devices (RT devices), air circuits, humidifiers, patient interfaces, and data This may include management.

[0020] 5.2.3.1 Patient Interface The patient interface provides, for example, airflow to the airway entrance, thereby assisting the respiratory system. It can be used to provide the wearer with an interface to the device. The airflow is through the nose. Provided via a mask to the mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. It is possible. Depending on the therapy applied, the patient interface may include, for example, the area of ​​the patient's face and This can form a sealed section, thereby providing sufficient pressure dispersion along with the ambient pressure for therapeutic execution. In (for example, in a positive pressure of approximately 10 cmH2O relative to the ambient pressure) To facilitate delivery. The sealed interface provides gas exhaust to the atmosphere. It may also have one or more vents. In other forms of therapy (e.g., high-flow therapy), the patient The interface may not be sealed (i.e., the sealing portion with the airway inlet). (In some cases, it may not form.) Airflow is through a cannula to the nose, a tube to the mouth, or the patient's breath. It can be supplied via a tracheostomy tube into the tube. This type of unsealed patient interface When used in combination with high-flow therapy, it substantially enables a significant therapeutic airflow, inter Air escapes through the gap between the face and the patient's nostrils. Under these conditions where air can escape... In this context, the pressure control environment (for example, between the patient and the cannula interface) is controlled. Due to the lack of this, sensing or detection related to the patient's use of therapy and / or the patient's respiration. The conditions may become somewhat confusing. Therefore, the embodiments of this technology are different from conventional systems. This is done to overcome the difficulty of obtaining a measurement method for such therapies while using the sar. obtain.

[0021] 5.2.3.2 Respiratory Therapy (RT) Devices Air pressure generators are well known in a certain range of applications (industrial-scale ventilation systems). However, in the case of pneumatic generators for medical use, there are specific requirements that cannot be met by more general-purpose pneumatic generators. There are requirements (for example, reliability, size, and weight requirements for medical devices). In addition, medical Even if a device is designed for a specific purpose, it may have one or more of the following drawbacks: There are: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost and Reliability.

[0022] One known RT device used to treat sleep-disordered breathing is the ResMed L There is the S9 sleep therapy system manufactured by Imited. Another example of an RT device is There is a ventilation system. ResMed Stellar (Registered) is a ventilation system for adults and children. Ventilation devices such as the registered trademark series have multiple conditions (to give non-limiting examples, CSR and Invasive and non-invasive, non-dependent exchange for a certain range of patients for the treatment of COPD They can provide energy support.

[0023] RT devices are typically pressure generators (e.g., motor-driven blowers or compressed gas storage devices). It includes a storage device and is configured to deliver airflow to the patient's airway. RT device outlet. It is connected to the patient interface via an air circuit as described above.

[0024] 5.2.3.3 Humidifier If airflow is delivered without humidification, it can cause dryness of the airways. Use a humidifier. When used with the T device and patient interface, a humidifying gas is generated, Dryness of the nasal and / or pharyngeal mucosa is minimized, and patient airway comfort is increased. In addition, In cold weather, warm air is blown onto the patient's face at and around the patient interface. In many cases, this provides more comfort than cold air. A certain range of artificial humidifiers and systems Although the technology is publicly known, it does not meet the specific requirements of medical humidifiers.

[0025] 5.2.3.4 Data Management Whether patients prescribed respiratory therapy are "complying" (for example, whether the patient is In accordance with the specific "compliance rules" related to the respiratory therapy performed, your RT device There may be clinical reasons for obtaining data to determine whether or not a product is being used. As an example of compliance rules for CPAP therapy, patients must adhere to the rules. For a patient to be considered to have the RT device, they must have used it continuously for at least 21-30 days. It is required to use the RT device for at least 4 hours per night. (High-flow therapy setting) In addition, similar compliance rules may be implemented. Determining patient compliance. Therefore, RT device suppliers (e.g., healthcare suppliers) provide patients with respiratory therapy. The therapeutic data to be described is obtained manually using an RT device, over a specified period of time. It is possible to infer / calculate usage and compare it with compliance regulations. Healthcare provider determined that patient used RT device in accordance with compliance regulations. Afterward, the healthcare provider informs a third party (e.g., an insurance company) that the patient You may notify us that you are complying with the regulations. You may not share therapeutic data with third parties or external parties. Regarding therapies for patients that benefit from communicating with the system, there may be other aspects. ru.

[0026] When a patient uses their own RT device to deliver CPAP therapy or other respiratory pressure therapy Conventional methods exist for analyzing therapeutic data to determine this. However, these methods are usually closed off. Due to the different air pressures in high-flow therapy caused by the characters not being displayed, this method is When used to determine whether the RT device is being used for high-flow therapy delivery, the results were It becomes inaccurate. Therefore, when RT devices are used or used in high-flow therapy Methods and devices are needed to determine when it occurred. [Overview of the project]

[0027] 6. Brief Summary of the Technology This technology is used in medical devices for the diagnosis, improvement, treatment, or prevention of respiratory diseases. In connection with the provision of these medical devices, improved comfort, cost, effectiveness, and ease of use are available. It possesses one or more of the following: and manufacturability.

[0028] Generally, this technology is used in devices for the diagnosis, improvement, treatment, or prevention of respiratory diseases. And regarding the method.

[0029] One form of this technology allows patients to use high-flow therapy based on flow and / or pressure signals. Includes apparatus and methods for determining whether or not it is being used. The method involves detecting significant changes in the respiratory rate band per unit time in one or more of these signals. By exploring the dynamics, it may be possible to determine whether the patient is using high-flow therapy.

[0030] According to one aspect of this technology, a method for determining whether high-flow therapy is being used by a patient. This method provides one or more controllers associated with a respiratory therapy device. The evaluation of the signals determines one or more signals from one or more sensors, and respiratory therapy Delivered from the legal device along the air circuit to the unsealed patient interface Whether the characteristics of the airflow include significant variations within a range of respiratory rate per unit time. This may include making a decision. Based on this decision, high-flow therapy may be administered to the patient. This also includes generating an output indication within the controller to show whether it is being used. obtain.

[0031] According to another aspect of this technology, a device is provided for delivering high-flow therapy to a patient. The device is Airflow to an unsealed patient interface along the air circuit in a predetermined therapeutic flow The device may include a servo-controlled blower configured to generate in quantity. One or more transducers configured to generate signals for each characteristic of the airflow. The device may include a central controller configured to control a servo-controlled blower. The device may include a processor. The processor may receive one or more signals. It can be configured. The processor is the airflow indicated by one of one or more signals. Controls the determination of whether the characteristic includes significant variation within a band of respiratory rate per unit time. The processor can be configured such that high-flow therapy is used by the patient, depending on the decision. It can be configured to generate an indication of whether it is being done.

[0032] According to another aspect of this technology, a device is provided for delivering high-flow therapy to a patient. The device is Flow handler generates airflow along the air circuit to an unsealed patient interface. The apparatus may include stages. The apparatus may include means for controlling the flow means. The apparatus generates air The apparatus may include means for generating one or more signals that represent different characteristics of the flow of air. The apparatus may include means for receiving signals. The apparatus is empty, indicated by one of one or more signals. Determine whether the characteristics of the airflow include significant variations within a range of respiratory rate per unit time. The device may include means to perform high-flow therapy on the patient, depending on the decision. This may include means for generating the indicator.

[0033] According to another aspect of this technology, a high-flow therapy system is provided. This may include an unsealed patient interface. The system is unsealed The system may include an air circuit configured to connect to a patient interface. This may include a servo-controlled blower configured to generate airflow along an air circuit. The system may include a central controller configured to control a servo-controlled blower. The system is configured to generate one or more signals that represent each characteristic of the generated airflow. It may include one or more transducers. The system may include a processor. A oscillator may be configured to receive one or more signals. A processor may receive one or more The airflow characteristics indicated by one of the signals fall within a range of respiratory rate per unit time. The processor may be configured to control the decision of whether to include significant variation in the following. Depending on the decision, it will generate an indication of whether high-flow therapy is being used by the patient. It can be constructed.

[0034] Of course, some of the above-mentioned phases can form lower-level phases of this technology. / or various combinations of one of the various aspects of this technology can be used to further explore the possibilities of this technology. Alternatively, lower-level positions can also be constructed.

[0035] Other features of this technology are included in the detailed description, drawings, and claims below. This becomes clear when you consider the following.

[0036] This technology is illustrated non-limitingly as an example in the attached drawings. Similar reference numerals in the drawings are: Includes the following similar elements: [Brief explanation of the drawing]

[0037] [Figure 1] [7.1 Treatment System] Figure 1 shows a system including a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a nasal pillow and receives positive-pressure air from an RT device 4000. The air from the RT device is humidified in a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. A co-sleeping person 1100 is also shown. [Figure 2] [7.2 Anatomical Structures of the Respiratory System and Face] Figure 2 shows an overview of the human respiratory system, including the nose and oral cavity, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 3a][7.3 Patient Interface] Figure 3a shows a sealed patient interface 3000 suitable for respiratory pressure therapy. [Figure 3b] Figure 3b shows an unsealed patient interface 3800. This patient interface 3800 is suitable for high-flow therapy and is used on patient 1000. [Figure 4a] [7.4 Respiratory Therapy Devices] Figure 4a shows the RT device 4000, which is one embodiment of this technology. [Figure 4b] Figure 4b is a schematic diagram of the pneumatic path of an RT device according to one embodiment of this technology. The upstream and downstream directions are shown. [Figure 4c] Figure 4c is a schematic diagram of the electrical components of an RT device according to one embodiment of this technology. [Figure 5a] [7.5 Humidifier] Figure 5a shows an isometric view of humidifier 5000. [Figure 5b] Figure 5b is an isometric view of the humidifier, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 6a] [7.6 Determining Therapy Usage] Figure 6a is a schematic diagram of the electrical circuit forming a simple model of an RT device that delivers high-flow therapy to a breathing patient via an open patient interface. [Figure 6b] Figure 6b is a schematic diagram of the electrical circuit forming a more advanced model of an RT device for delivering high-flow therapy to a patient breathing. [Figure 6c] Figure 6c is a schematic diagram of the electrical circuit forming a two-nostril model of an RT device for delivering high-flow therapy to a patient breathing. [Figure 7a] Figure 7a is a flowchart illustrating a method for determining whether a patient is receiving high-flow therapy using one embodiment of this technology. [Figure 7b] Figure 7b is a flowchart illustrating a method for monitoring a patient's high-flow therapy using one embodiment of this technology. [Modes for carrying out the invention]

[0038] Before describing this technology in more detail, it should be noted that this technology differs from the differences described herein. It should be understood that this is not limited to specific examples obtained in this disclosure. The terms used herein are for illustrative purposes only and are not limited to those used in this specification. It should also be understood that this is not the case.

[0039] The following description relates to a variety of examples that may share one or more common characteristics and / or features. Provided as follows: One or more features of any one example may be one or more of another example or any other example. It should be understood that it is possible to combine these features. In addition, these examples Any single feature or combination of features in any of these constitutes further examples. It is possible.

[0040] 8.1 Therapy In one form, this technology directs a high-flow airflow to the vicinity of the airway entrance of 1000 patients. A method for treating a respiratory disease, including a step of delivery.

[0041] In a specific example of this technology, airflow is directed through one or both nostrils to clear the patient's nasal passages. It is delivered to the road at high flow rates.

[0042] 8.2 Treatment System In one embodiment, this technology includes an apparatus or device for the treatment of respiratory diseases. Alternatively, the device may be supplying a high flow rate of air to the patient via an unsealed patient interface. This may include an RT device 4000 that delivers to -3800 via an air circuit 4170.

[0043] 8.3 Patient Interface One aspect of this technology is a non-invasive, sealed patient interface 3000, which includes the following: Functional aspects include: sealing forming structure 3100, cavity chamber 3200, positioning and stabilizing structure 3 A type 300, a ventilation hole 3400, and a connection port 3600 for connection to an air circuit 4170. The form and the forehead support portion 3700. When in use, the sealing structure 3100 is a positive pressure air. It is positioned to surround the entrance to the patient's airway in order to facilitate the supply of qi to the airway.

[0044] The unsealed patient interface 3800 takes the form of a nasal cannula and nasal protrusion. Includes 3810a and 3810b. Nasal projections 3810a and 3810b are affected by air. It can be delivered to each nostril of 1000 individuals. Such nasal projections can be delivered inside or outside the nostril. Often, it does not form a seal with the lateral skin surface. Air into the nasal process is not sealed in patients. Interface 3800 and one or more air supply routes connected in nasal cannula form Lumens 3820a and 3820b can be delivered. 20b extends from the nasal cannula-shaped, unsealed patient interface 3800. ...extending to RT devices that generate high-flow airflow.

[0045] Another example of an unsealed patient interface 3800 is a transtracheal interface. There is a space.

[0046] 8.4 Respiratory Therapy Devices One aspect of this technology, the RT device 4000, comprises mechanical and pneumatic components 4100. , including electrical components 4200, configured to execute one or more algorithms 4300 The RT device may have an external housing 4010. External housing 4010 It is formed as two parts: an upper portion 4012 and a lower portion 4014. Furthermore, The external housing 4010 may include one or more panels 4015. The RT device 4000 supports one or more internal components of the RT device 4000. The chassis 4016 is included. The RT device 4000 may include the handle 4018.

[0047] The pneumatic path of the RT device 4000 consists of one or more air path items (e.g., inlet air). Air filter 4112), inlet muffler 4122, pressure generator capable of delivering air at high flow rates Forming device 4140 (e.g., blower 4142), exhaust muffler 4124 and one or more traps Reducer 4270 (for example, pressure sensor 4272 and flow sensor 4274) It may include.

[0048] One or more of the air passage items are a movable, integrated structure called the pneumatic block 4020. The pneumatic block 4020 may be located inside the external housing 4010. In one embodiment, the pneumatic block 4020 is supported by the chassis 4016. Alternatively, it is formed as part of chassis 4016.

[0049] RT device 4000 has a power supply 4210, one or more input devices s4220, and a central control Device 4230, therapy device controller 4240, pressure generator 4140, one or more protective circuits 4250, Memory 4260, Transducer 4270, Data communication interface 4 It may have 280 and one or more output devices 4290. The electrical components 4200 are single It can be mounted on a printed circuit board assembly (PCBA) 4202. In other forms... Therefore, the RT device 4000 may contain more than one PCBA4202.

[0050] 8.4.1 Mechanical & Pneumatic Components of RT Devices An RT device may include one or more of the following components as a single unit: In terms of form, one or more of the following components may be arranged as separate units. .

[0051] 8.4.1.1 Air filter (single or multiple) An RT device according to one form of this technology includes an air filter 4110 or multiple air filters. May include Ta4110.

[0052] In one embodiment, the inlet air filter 4112 is located upstream of the pressure generator 4140. It is placed at the beginning of the pressure path.

[0053] In one embodiment, the outlet air filter 4114, such as an antibacterial filter, is a pneumatic block It is positioned between the 4020 exit and the patient interface.

[0054] 8.4.1.2 Muffler (singular or plural) In one embodiment of this technology, the inlet muffler 4122 is located upstream of the pressure generator 4140. It is placed within the pneumatic path.

[0055] In one embodiment of this technology, the outlet muffler 4124 connects to the pressure generator 4140 and the patient interface - It is located within the air pressure path between the face and the other.

[0056] 8.4.1.3 Pressure Generator In one embodiment of this technology, the pressure generator 4140 that generates airflow at a high flow rate is a saturator This is a controlled blower 4142. For example, the blower 4142 is a brushless DC motor 414 4 may include one or more impellers housed in the volute. The blower 4142 is The airflow can be servo-controlled to deliver a therapeutic flow rate Qth. In this configuration, the total airflow rate Qt is supplied to the flow transducer and blower 414 as follows: It is monitored by a rate of 2, thereby setting the total flow rate Qt to the therapeutic flow rate Qth or close to it. The airflow pressure Pd at the output of blower 4142 is adjusted to maintain the following condition. The therapeutic flow rate Qth can be as high as approximately 120 liters / min, but more typically it is 20-3 liters / min. It can be within the range of 0 liters / minute.

[0057] The blower 4142 may be described in any one of the following patents or patent applications, In this document, the entirety of the following document is referenced: U.S. Patent No. 7,866,944, U.S. Patent. U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479; and PCT Patent Application Publications WO2013 / 020167.

[0058] The pressure generator 4140 is under the control of the therapy device controller 4240.

[0059] In other forms, the pressure generator 4140 is a piston-driven pump, a high-pressure source (for example, This could be a pressure regulator or bellows connected to a compressed air reservoir.

[0060] 8.4.1.4 Transducer (singular or plural) The transducer 4270 may be located inside the RT device, or in the RT device It may be located outside the vise. The external transducer may be placed on the air circuit. or may form part thereof (for example, a patient interface). External transformer Deucers can take the form of non-contact sensors (e.g., for data transmission to a device or (Doppler radar moving sensor that performs data transfer).

[0061] In one embodiment of this technology, one or more transducers 4270 are pressure generators 414 It is positioned upstream and / or downstream of 0. One or more transducers 4270 are special Properties (for example, flow rate, pressure, absolute or relative humidity or temperature at a point in the pneumatic path) It can be constructed and positioned to measure degrees. Transducer 4270 is used to measure these It generates signals that indicate the characteristics and transmits these signals to the central controller 4230.

[0062] In one embodiment of this technology, one or more transducers 4270 provide a patient interface It may be placed in the vicinity of the . In another form of this technology, one or more transducers 4 270 may be located near the air outlet of the RT device 4000. External transducer The ambient conditions (e.g., ambient pressure, temperature, or relative or absolute humidity) are measured. It may be used for that purpose.

[0063] In one configuration, the signal from transducer 4270 is (for example, low-pass, high-pass). It can be filtered (by path or bandpass filtering).

[0064] 8.4.1.4.1 Flow Transducer The flow transducer 4274 using this technology is a differential pressure transducer (for example, SE Based on the SDP600 series differential pressure transducer from NSIRION.

[0065] In one embodiment, the flow transducer 4274 delivers from the RT device 4000 A signal is generated that indicates the total flow rate Qt of the airflow being transmitted.

[0066] 8.4.1.4.2 Pressure Transducer The pressure transducer 4272 in this technology is arranged in fluid communication with the pneumatic path. As an example of a suitable pressure transducer, the HONEYWELL ASDX series or These sensors are available. Another suitable pressure transducer is GENERAL ELE There are sensors from CTRIC's NPA series.

[0067] In one embodiment, the pressure transducer 4272 is located at the outlet of the RT device 4000. It generates a signal indicating the pressure Pd of the airflow.

[0068] 8.4.1.4.3 Motor Speed ​​Transducer In one embodiment of this technology, the motor speed transducer 4276 is connected to the motor 4144 It can be used to determine the rotational speed of the blower 4142. The motor speed signal from the motor 4276 can be provided to the therapy device controller 4240. The speed transducer 4276 is used with speed sensors such as Hall effect sensors. could be.

[0069] 8.4.1.4.4 Other transducers One or more humidity / temperature sensors, such as SensirionSHT75, monitor the flow of therapeutic air. This can be used to determine the humidity and temperature, as well as the ambient humidity and temperature.

[0070] One or more electrical sensors are connected to the motor 4144 or the humidifier 5000 or their respective power supply units. It can be configured to sense the current consumed by the knit. The sensed current is used for treatment. Used to determine the instantaneous or average power consumed by a system or its components. It is possible.

[0071] 8.4.1.5 Spillback prevention valve In one embodiment of this technology, the spillback prevention valve is located between the humidifier 5000 and the pneumatic block 4 It is positioned between 020. The spillback prevention valve prevents water from flowing upstream of humidifier 5000. It is constructed and positioned to reduce the risk of flowing to motor 4144.

[0072] 8.4.1.6 Air Circuit The air circuit 4170 in this aspect of the technology consists of two components (for example, a pneumatic block 4 The device is designed to allow airflow to move between the 020 and the patient interface during use. It is a constructed and laid conduit or pipe.

[0073] In detail, the air circuit 4170 is connected to the outlet and patient interface of the pneumatic block. Fluid connections are possible. This air circuit may be called an air delivery tube. In some cases, suction and There may be separate protrusions for the circuit for exhalation. In other cases, a single protrusion is used. It is possible.

[0074] In some forms, the air circuit 4170 heats the air in the air circuit (for example) It may include one or more heating elements configured to maintain or increase the air temperature. The heating element may take the form of a heating wire circuit and consist of one or more transducers (e.g., heating It may include a temperature sensor. In one embodiment, the heating wire circuit is located around the axis of the air circuit 4170. It can be wound spirally around the enclosure. The heating element is controlled by a controller (e.g., a central controller 4230 or an additive controller). It can communicate with the humidifier controller (5250). An example of the air circuit 4170 including the heating wire circuit is shown below. This is described in U.S. Patent Application No. US / 2011 / 0023874. In this specification, The entire document is used for reference.

[0075] 8.4.1.7 Oxygen delivery In one embodiment of this technology, additional oxygen 4180 is supplied to one or more points in the pneumatic path ( For example, upstream of the pneumatic block 4020, the air circuit 4170 and / or the patient interface - Delivered to the face.

[0076] 8.4.2 RT Device Electrical Components 8.4.2.1 Power supply Power supply 4210 is located inside or outside the external housing 4010 of the RT device 4000. It can be placed.

[0077] In one embodiment of this technology, the power supply 4210 provides power only to the RT device 4000. In another embodiment of this technology, the power supply 4210 powers the RT device 4000 and the humidifier 5 Provides power to both sides.

[0078] 8.4.2.2 Input Devices In one form of this technology, the RT device 4000 enables interaction between a person and the device. One or more input devices 42 in the form of buttons, switches, or dials for use as input devices. Includes 20. Buttons, switches, or dials may be physical devices or Alternatively, it may be a software device accessible via a touchscreen. The buttons, switches, or dials are, in one form, physically located on the external housing 4010. They may be connected directly, or they may be electrically connected to the central controller 4230 in another configuration. It is also permissible to communicate wirelessly with the receiver.

[0079] In one embodiment, the input device 4220 allows a person to input values ​​and / or menu options. It can be constructed and configured to allow selection.

[0080] 8.4.2.3 Central Controller In one embodiment of this technology, the central controller 4230 is suitable for controlling the RT device 4000. It is one or more processors.

[0081] The appropriate processor is ARM® Cort from ARM Holdings. ex(registered trademark)-M processor (for example, from ST MICROELECTRONIC) x86 Intel processor based on STM32 series microcontrollers This may include a processor. In certain other forms of this technology, a 32-bit RISC CPU. (For example, the STR9 series microcontrollers from ST MICROELECTRONICS) Microcontrollers manufactured by Goki or TEXAS INSTRUMENTS 16-bit RISC CPUs such as processors from the SP430 family are also suitable. It is possible.

[0082] In one embodiment of this technology, the central controller 4230 is a dedicated electronic circuit.

[0083] In one embodiment, the central controller 4230 is an application-specific integrated circuit. In another embodiment, Furthermore, the central controller 4230 is an individual electronic component.

[0084] The central controller 4230 has one or more transducers 4270 and one or more input devices It can be configured to receive input signals (one or more) from Vice 4220.

[0085] The central controller 4230 controls the output device 4290, the therapy device controller 4240, and data Output signal to one or more of the communication interface 4280 and humidifier controller 5250 ( It can be configured to provide (singular or plural).

[0086] In some forms of this technology, the central controller 4230 is one of the following described herein. The above method (for example, non-temporary computer-readable storage medium (for example, memory 4) 260) One or more algorithms expressed as computer programs stored within It is configured to perform (M4300). In some forms of this technology, centralized The 4230 can be integrated with the RT device 4000. However, some aspects of this technology In terms of form, several methods can be performed by remotely positioned devices. For example, Remotely located devices store data (e.g., sensors described herein). The control settings for the ventilation system are determined by analysis of any of the following: Respiratory-related illnesses can be detected.

[0087] 8.4.2.4 Clocks The RT device 4000 may include a clock 4232 connected to the central controller 4230.

[0088] 8.4.2.5 Therapy device controllers In one embodiment of this technology, the therapy device controller 4240 is controlled by the central controller 4230. This is a control module 4330 that forms part of the algorithm 4300 that is executed.

[0089] In one embodiment of this technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 bra manufactured by ONSEMI A Siles DC motor controller is used.

[0090] 8.4.2.6 Protection circuit One or more protection circuits 4250 in this technology include electrical protection circuits, temperature and / or pressure protection circuits. It may include a safety circuit.

[0091] 8.4.2.7 Memory According to one embodiment of this technology, the RT device 4000 has a memory 4260 (for example, non-volatile Includes static memory. In some forms, memory 4260 is battery-powered static RAM. It may include. In some forms, memory 4260 may include volatile RAM.

[0092] Memory 4260 may be located on PCBA4202. Memory 4260 is EPR It can take the form of OM or NAND flash memory.

[0093] Additionally or alternatively, the RT device 4000 includes a removable form of memory 42 Includes 60 (for example, memos prepared in accordance with Secure Digital (SD) standards) Ricardo).

[0094] In one embodiment of this technology, the memory 4260 is one or more of the methods described herein (e.g., For example, a stored computer program that represents one or more algorithms (4300) It functions as a non-temporary, computer-readable storage medium on which instructions are stored.

[0095] 8.4.2.8 Data Communication System In one embodiment of this technology, a data communication interface 4280 is provided, and central control It is connected to device 4230. The data communication interface 4280 is a remote external communication network. It is possible to connect to work 4282 and / or local external communication network 4284. The remote external communication network 4282 can connect to the remote external device 4286. It is possible. The local external communication network 4284 connects to the local external device 4288. It may be possible to continue.

[0096] In one configuration, the data communication interface 4280 is part of the central controller 4230. In another configuration, the data communication interface 4280 is connected to the central controller 423 It is distinct from zero and may include an integrated circuit or processor.

[0097] In one form, the remote external communication network 4282 is the Internet. The communication interface 4280 is used to connect to the internet (for example, Ethernet Wired communication may be used (via the internet or optical fiber), or wireless communication may be used. A rotocor (e.g., CDMA, GSM®, LTE) may be used.

[0098] In one configuration, the local external communication network 4284 uses one or more communication standards (e.g., For example, Bluetooth® or Consumer Infrared Protocol or Powerline Communication Use (trust).

[0099] In one embodiment, the remote external device 4286 is one or more computers (for example) (For example, a cluster of network computers). In one form, a remote external device 428 6 could be a virtual computer rather than a physical computer. In either case, this Such remote external devices 4286 are accessible to appropriately approved individuals, such as clinicians. It is possible.

[0100] Local external device 4288 is a personal computer, mobile phone, tablet, etc. It can be controlled remotely.

[0101] 8.4.2.9 Output Devices The output device 4290 using this technology comprises one or more of the following units: visual, auditory, and haptic. It can take the form of a liquid crystal display (LCD) or a light-emitting diode. It could be an LED display.

[0102] 8.4.2.9.1 Display Driver Display driver 4292 controls the characters and notes that should be displayed on display 4294. It receives numbers or images as input and converts them into commands. Display 4294 will then display these characters, symbols, or images.

[0103] 8.4.2.9.2 Display Display 4294 responds to commands received from display driver 4292 In response, it is configured to visually display letters, symbols, or images. For example, a display Ray 4294 can be an 8-segment display, in which case display driver 4 292 represents each character or symbol (for example, the number "0") to display a specific character or symbol. It converts into eight logic signals that indicate whether to activate each of the eight segments. .

[0104] 8.4.2.9.3 Warning The output device 4290 may take the form of a warning generator. The warning is a visual indicator. For example, it may take the form of a flashing light or an audio signal (for example, a beep).

[0105] 8.4.3 RT Device Algorithm 8.4.3.1 Determining the use of high-flow therapy This technology represents an improvement in the field of respiratory therapy (specifically, respiratory therapy using respiratory therapy devices). Provides (singular or plural). For example, this technology provides an unsealed patient interface The system automatically determines the patient's status associated with the use of high-flow therapy when a certain condition is being used. This can enable the determination of a device. Such a determination (singular or plural) is made by the processor. This can be done in such a way that improvements can be made in the functionality of the controller or processor (one or more). ) provides. For example, in one form of this technology, an algorithm is used to determine how to use high-flow therapy. The rhythm is a signal indicating the pressure Pd at the RT device outlet, and from RT device 4000 It receives a signal indicating the total flow rate Qt of the delivered air as input. The algorithm for determining the treatment method is based on whether high-flow therapy is being used by 1000 patients. The system generates a time series of usage indicators as output at consecutive time points.

[0106] In one embodiment of this technology, the central controller 4230 of the RT device 4000 performs high-flow therapy An algorithm can be executed to determine how to use it.

[0107] In other forms of this technology, the algorithm for determining how to use high-flow therapy is remotely external. Remote This can be executed by the processor of the 4286 external computing device. In this configuration, the RT device 4000 exhibits the device pressure Pd and total flow rate Qt. The signal is transmitted to a remote external computing device via the remote external communication network 4282. It can be sent to 4286. Subsequently, the remote external computing device 4286 receives high current. Execute the algorithm to determine how to use dosage therapy.

[0108] Furthermore, in other forms, the algorithm for determining how to use high-flow therapy is RT Device The system can be operated by the central controller 4230 of the S4000, and partially by remote external computers. This can be executed by the processor of the 4286 processing device. For example, the central controller 4230 It can process device pressure and total flow signals to generate intermediate outputs, and these intermediate outputs The output can be sent to the processor of the remote external computing device 4286, and then to the intermediate output. The data is processed, and a time-series usage indicator is generated.

[0109] In either case, the algorithm that determines how to use high-flow therapy is "real time". It may be implemented, or as a post-process (i.e., after the completion of the therapy session). This may be performed on stored data showing device pressure Pd and total flow rate Qt. When processing is executed, device pressure and flow rate data are predefined as time-series samples. The RT device 4000's memory 4260 and / or remotely at the specified sampling rate. It can be stored in the memory of the external computing device 4286.

[0110] The device pressure and total flow signals are transmitted to the appropriately positioned pressure transducer 427. 2 and the flow transducer 4274 are generated, respectively. Another form of this technology In this context, the algorithm for determining how to use high-flow therapy is the pressure within the patient interface. The system receives a signal indicating force Pm as input. The patient interface pressure Pm is appropriately positioned. It may be generated directly by the specified pressure transducer 4272, or by input The pressure compensation algorithm, which also takes the total flow rate Qt as a force, is formed from the device pressure Pd. This is also good. The pressure compensation algorithm is the pressure reduction through the air circuit 4170 using the total flow rate Qt. Infer the value below and subtract it from the inferred pressure drop device pressure Pd to determine the patient interface. Calculate the pressure Pm.

[0111] The RT device 4000 is generated by an algorithm that determines how to use high-flow therapy. The usage patterns can be accumulated in a time-series record of high-flow therapy usage for 1000 patients. The T device 4000 can take different actions based on records of such usage. One example of such action is high-flow therapy over a given interval for 1000 patients. We sometimes generate compliance reports that summarize how to use [the system]. Such reports are often far away Through the remote external communication network 4282, for example, associated with healthcare suppliers It can be transferred to a remote external computing device 4286.

[0112] In another example, the therapy control module 4330 of the RT device 4000 controls high-flow therapy In response to the recording of usage, one or more parameters of high-flow therapy (e.g., therapeutic flow rate Qt) will be recorded. h) can be adjusted. For example, the usage record shows that the usage is decreasing over time. In some cases, the therapeutic flow rate Qth can be reduced to encourage the use of high-flow therapy. In some cases, the usage indication or accumulated records are evaluated within the controller, R It can function as a trigger for a change in the operation of the controller of the T device 4000. For example, when sufficient usage indicators are met (for instance, when a specific time threshold is met) If the usage indicator indicates that the device is not being used at all, the controller will Treatment may be discontinued (for example, by changing the control operation of the blower motor, the flow Reduce generation or stop flow generation.

[0113] The RT device 4000, based on usage indications or their stored records, (output data (Through Vice 4290) a warning may be generated. For example, if the accumulated records show that patient 1000 If it indicates that the use of high-flow therapy has been interrupted for more than the prescribed interval, RT device 400 A value of 0 may generate a warning. Such a warning is, for example, an output of RT device 4000. Obtain (for example, the voice generator or speaker of RT device 4000 or RT device 4 Activation of other voice generators or speakers of the device communicating with 000 or RT device 4000 Display 4294 Output Warning Light Activation or RT Device 4000 Trust local or remote external device 4288 or 4286 other display activity sexualization).

[0114] Figure 6a is a circuit diagram of the electrical circuit model 6000. The electrical circuit model 6000 is a high-current 1000 patients receiving dose therapy via an unsealed patient interface (for example, RT device 40 delivered via an unsealed patient interface 3800) This is a simple model of 00. In the electrical circuit model 6000, voltage models pressure, Current models flow rate. The RT device 4000 is controlled by the voltage source 6010. The air circuit 4170 is modeled by the resistor 6030. Total flow rate Qt is modeled by the current in the air circuit resistance 6030, and the device pressure Pd is the electric current. Modeled by the voltage at the output of pressure source 6010. Unsealed patient interface - The pressure Pm within face 3800 is determined by the voltage at the end of the air circuit resistor 6030. It is modeled as follows: If the air circuit 4170 is blocked, the air circuit resistance 6030 is infinite. (That is, open circuit). The inside of the unsealed patient interface 3800 and the patient The resistance between the inside of the person's nose and the interface resistor 6050 is modeled by the interface resistor 6050. The pressure inside the patient's nose (Pnose) is determined by the voltage at the end of the interface resistor 6050. It is modeled as such.

[0115] The respiratory system of patient 1000 is connected in series with a capacitance 6035 and an AC voltage source 6020, and an airway resistor. Anti-6025 is modeled by capacitance 6035, which is used to measure the pneumatic compliance of the patient's lungs. Model the ANS. The AC voltage source 6020 has a small negative value during the inspiratory portion of the respiratory cycle. By moving back and forth between the voltage and the small positive voltage during the exhalation phase of the respiratory cycle. This modeled the respiration of 1000 patients.

[0116] Figure 6b is a circuit diagram of electrical circuit model 6100. Electrical circuit model 6100 is shown in Figure 6 Instead of electrical circuit model 6000, use the unsealed patient interface 3800. The RT device 4000 delivers high-flow therapy to 1000 patients who are breathing via This is an advanced model. Electrical circuit model 6100 includes elements 6110, 6120, 6125, Includes 6130, 6135, and 6150. These elements are part of the electrical circuit model 6000. Each of its relatives within it is 6010, 6020, 6025, 6030, 6035 and 6050. They are the same. Circuit model 6100 is in parallel with patient model 6025 / 6010. It also includes an additional "leakage resistor" 6140 for grounding. The leakage resistor 6140 is sealed. Patient interface 3800 without a patient interface and patient interface 380 without a seal The entry point (singular or plural) to the airway (singular or plural) of patient 1000, which serves as the interface with 0. This model represents the leakage pathway from inside the patient's nose to the atmosphere caused by gaps between (or multiple) parts of the nose. Therefore, the total flow rate Qt is lower than the patient airway resistance of 6140. The patient respiratory flow rate Qr, modeled as the current in resistor 6125, is significantly different. This refers to the interface being properly positioned on the patient's face, rather than the leakage resistance 6140. A much higher impedance model that simulates the airflow into the atmosphere through the 3400 vents. A more conventional sealed or pressurized device used for the delivery of respiratory pressure therapy. This is in contrast to the system described above. In such a system, the impedance to the atmosphere When the patient's respiratory pressure decreases significantly, the interface with the patient when using respiratory pressure therapy becomes less effective. A significant difference in static pressure occurs in the system between the time of connection and disconnection. Therefore, a method to detect from static pressure when a patient is using respiratory pressure therapy is a simple one. It's straightforward.

[0117] Leak resistance 6140 is for the airway inlet of the unsealed patient interface 3800 (single It depends on the relative position (one or more). This is impossible to predict with high accuracy. Therefore, the leakage resistance 6140 is modeled as a variable. Unsealed patient interface If the Face 3800 is disconnected from the patient's airway inlet, the leakage resistance becomes extremely low. In other words, it becomes close to a short circuit.

[0118] In one run, the controlled voltage source 6110 is servo-controlled, AC power The output voltage of pressure source 6120 fluctuates throughout the respiratory cycle (modeling patient respiration). Maintain the therapeutic flow rate Qth or the total flow rate Qt around it. Perform one servo control operation. In this configuration, the device pressure Pd is in phase with the output of the AC voltage source 6120, and the patient pressure is 1000 units. The number of breaths per unit time fluctuates around the steady (DC) pressure (i.e., Qt decreases during the inspiratory phase and increases during the expiratory phase, and the total flow rate Qt is maintained throughout the entire respiratory cycle. (The therapeutic flow rate Qth remains constant). This is performed using a controlled voltage source 61 This can be modeled by replacing 10 with a constant current source that supplies current Qth. In another implementation of vo control, the device pressure Pd remains constant throughout the entire respiratory cycle. Up to, the total flow rate Qt is the AC voltage source at 1000 respiratory rate per unit time for a patient. The output of the 6120 is in opposite phase to the therapeutic flow rate Qth, which fluctuates around (i.e., (AC voltage) (When the value is negative) the therapeutic flow rate Qth becomes higher in the inspiratory portion, (when the AC voltage is positive) (In the exhalation portion, the therapeutic flow rate Qth becomes lower). Other intermediate executions of servo control And, in terms of the number of respiratory rates per unit time for 1000 patients, the total flow rate Qt is equal to the therapeutic flow rate Qth. Around it, the output of the AC voltage source 6120 fluctuates slightly in opposite phase (i.e., in the intake area) In the exhalation portion, the therapeutic flow rate is slightly higher than Qth, and in the exhalation portion, it is slightly lower than Qth. ). On the other hand, the device pressure Pd is the same as the output of the AC voltage source 6120 around the steady-state pressure. varies slightly in the phase (i.e., slightly decreases in the inhalation part and slightly increases in the exhalation part ). In practice, regardless of the execution, the transducer 427 used for servo control execution 0 is incomplete, so there are slight but non-zero fluctuations in both the device pressure Pd and the total flow rate Qt per unit time in the respiratory rate. Depending on the execution of servo control , it is determined whether the device pressure Pd mainly varies, the total flow rate Qt mainly varies, or both signals vary .

[0119] One of the purposes of the algorithm for determining the usage method of the high-flow therapy of the present disclosure is to detect these fluctuations in the device pressure Pd and / or the total flow rate Qt within the bandwidth of the respiratory rate per unit time generated from the patient 1000 using high-flow therapy . It is advantageous to make this detection substantially independent of the execution of servo control. This is because this execution is not necessarily known to the algorithm for determining the usage method of the high flow of the present disclosure . . Such fluctuations do not exist when the patient 1000 is not using high-flow therapy (for example, when the air circuit 4170 is blocked or the connection is disconnected from the patient's airway inlet ).

[0120] FIG. 7a is a flowchart showing a method 7000 that can be used to execute an algorithm for determining the usage method of high-flow therapy according to an embodiment of the present technology. Hereinafter, the method 7000 will be described using the device pressure Pd. However, when appropriate thresholds are set, the method 7000 functions effectively using the patient interface pressure Pm . .

[0121] Method 7000 starts from step 7010. Step 7010 determines whether the total flow rate Qt exceeds a flow rate threshold. In one implementation, the flow rate threshold is 10 liters per minute . Step 7010 is intended to determine whether the RT device 4000 is delivering air flow at a high flow rate . Reasons for not delivering high flow include that the pressure generator 41 40 is not operating or is malfunctioning, or the air circuit 4170 or the non - sealed patient interface 3800 is obstructed or blocked. If the total flow rate Qt does not exceed the flow rate threshold ( "N"), method 7000 proceeds to step 7070. . Step 7070 returns a "false" value indicating that patient 1000 is not using high - flow therapy.

[0122] If the total flow rate Qt exceeds the flow rate threshold ( "Y"), method 7000 proceeds to step 7020. In step 7020, both the total flow rate Qt and the device pressure Pd are band - pass filtered to cover the range of respiratory rate variations or frequency range (the band of respiratory rate per unit time) that encompasses the limits of the number of breaths per unit time of a human. Step 7020 is intended to remove components of short - term variations in pressure and flow (i.e., variations in the number of breaths or frequency beyond the typical number of breaths per unit time). Such components are "noise" in the sense that they are not relevant to determining whether high - flow therapy is being used by patient 1000. In one implementation, the upper cut - off frequency of the band - pass filter is approximately 0 .5 Hz (i.e., 0.5 breaths per second), which is approximately the upper limit of the number of breaths per unit time of a human at rest. Step 7020 is for long - term variations (i.e., .5 Hz (that is, 0.5 breaths per second). Step 7020 is for long - term variations (i.e., (i.e., fluctuations in the number or frequency of breaths below the typical respiratory rate per unit time.) The intention is also to remove all of the components of the bandpass filter in one run. The lower cutoff frequency or rate is approximately below the resting respiratory rate per unit time of a human. The limit is 0.1Hz. The bandpass filtering in step 7020 is bandpass The average or steady-state values ​​of the filtered total flow rate Qt' and device pressure Pd' are It is configured to remain constant from the values ​​of the total flow rate Qt and the device pressure Pd.

[0123] Fixed upper cutoff count or frequency and lower cutoff count or frequency As an alternative use, in bandpass filtering step 7020, the patient's single The respiratory rate per unit time can be estimated first. This can be calculated using, for example, the total flow rate Qt and the device pressure. For example, in the Fourier transform of the ratio of force Pd, or total flow rate Qt, to device pressure Pd. The position of the highest peak (for example, determined by the Fast Fourier Transform algorithm) This can be done by searching. This ratio is per unit time regardless of servo control execution. It is useful because it has a significant component in the respiratory rate. The highest peak position is in the patient. This is an estimation of the respiratory rate per unit time. Then, a bandpass filtering step is performed. The upper cutoff count or frequency and the lower cutoff count or frequency of the 7020 are: This can be derived from an estimate of the number of breaths per unit time. For example, the lower cutoff number or The frequency may be half of the estimated number of breaths per unit time, and the upper cutoff number or frequency may be the frequency. The wavenumber can be twice the estimated number of breaths per unit time.

[0124] Fixed upper cutoff count or frequency and lower cutoff in step 7020 As a further alternative to using the number of off cycles or frequencies, patient height can be used appropriately. Examples of determining the number of upper and lower cutoff frequencies. This is because, according to well-known physiological relationships, the patient's height corresponds to the unit time of a person at rest. This is because it is related to the respiratory rate per unit. Patient height is R via input device 4220 This can be entered as a setting for device T4000.

[0125] After step 7020, the bandpass filtered total flow Qt' and device The only component of the fluctuation remaining in pressure Pd' is applied in step 7020. The bandpass frequency (equal to [0.1Hz, 0.5Hz] in one of the above executions) The number of breaths per unit time is determined by the filter's cutoff frequency or frequency. These are components of the frequency within a band. These are the variations within a band of respiratory rate per unit time. The components are superimposed on the (positive) steady-state (average) values ​​of the total flow rate Qt and the device pressure Pd. It can be done.

[0126] In the next step 7030, the bandpass filtered device pressure Pd' By dividing by the bandpass filtered total flow rate Qt', the air circuit The resistance to flow in 4170 is calculated. The resistance to flow is calculated using two bandpass factors. Because it is calculated from the filtered signal, the resistance to the flow is also bandpass filtering. Although not directly obtained from the signal, as a bandpass filtered signal It can be considered as such.

[0127] Next, step 7035 determines whether the resistance to flow is within a predetermined range that is characteristic of patient 100 using high flow therapy. In one implementation, the predetermined range is 0.4 cmH2O / liter / min to 0.9 cmH2O / liter / min. If step 7 035 determines that the resistance to flow is not within the predetermined range ("N"), method 7 000 proceeds to step 7070 and returns a "false" value. The resistance to flow is substantially independent of the execution of servo control applied from RT device 4000 to device pressure Pd. As described above, in one execution of servo control, all variations in the respiratory rate band are those of device pressure Pd. In another execution of servo control, all variations in the respiratory rate band are those of total flow rate Qt. In any execution, in all intermediate executions, as long as patient 1000 is using high flow therapy, the ratio of device pressure Pd to total flow rate Qt (resistance to flow) remains within the predetermined range. However, since this is not a sufficient condition to determine that high flow therapy is being used, if step 703 5 determines that the resistance to flow is not within the predetermined range ("Y"), method 700 0 proceeds to step 7040. Steps 7040 and 7045 are intended to determine whether the characteristics of the delivered air flow include significant variations within the band of human respiratory rate per unit time defined by the cut-off number or frequency of step 7020. Therefore, step 7040 calculates the magnitude of one variation of the band-pass filtered signal over a sliding window of a predetermined duration. In one implementation, step 7040 is the band-pass filtered signal over a sliding window of a predetermined duration. In one implementation, step 7040 is the band-pass filtered signal over a sliding window of a predetermined duration. In one implementation, step 7040 is the band-pass filtered signal over a sliding window of a predetermined duration. In one implementation, step 7040 is the band-pass filtered signal over a sliding window of a predetermined duration. In one implementation, step 7040 is the

[0128] Steps 7040 and 7045 are for the purpose of determining whether the characteristics of the delivered air flow include significant variations within the band of the respiratory rate per unit time of a human defined by the cut-off number or frequency of step 7020. Therefore, step 7040 calculates the magnitude of one variation of the band-pass filtered signal over a sliding window of a predetermined duration. In one implementation, step 7040 calculates the magnitude of one variation of the band-pass filtered signal over a sliding window of a predetermined duration. In one implementation, step 7040 calculates the magnitude of one variation of the band-pass filtered signal over a sliding window of a predetermined duration. In one implementation, step 7040 calculates the magnitude of one variation of the band-pass filtered signal over a sliding window of a predetermined duration. In one implementation, step 7040 is the The target over a 1-minute duration sliding window of the pass-through filtered signal. Calculate the standard deviation. This standard deviation is sensitive to the mean over this window. Therefore, it is usable and thus encompasses all changes within the window. Other executions of p7040 are listed below: ·Average subtracted bandpass filtered across the slide window Calculating the magnitude of fluctuations using the number of zero crossings in a signal; • The range of respiratory rate per unit time calculated across the slide window Calculate the power of the Fourier transform spectrum of the (unfiltered) signal. to do; • The number of breaths per unit time calculated over a predetermined window of duration. Fourier transform spectrum of the (unfiltered) signal in the harmonics of the bandwidth The power is calculated, and therefore, harmonics (for example, indicating the presence of snoring) are also calculated for 1000 patients. It shows inhalation.

[0129] A suitable step for execution where the device pressure Pd remains constant throughout the entire respiratory cycle. In one run of the 7040, the bandpass filtered signal is bandpass filtered This is the filtered total flow rate Qt'. The total flow rate Qt remains constant throughout the entire respiratory cycle. In another execution of step 7045, which is suitable for continued execution, bandpass filtering The filtered signal is the bandpass filtered device pressure Pd'. Servo control In yet another execution of step 7045, which is suitable for intermediate execution, a bandpass filter The signal that is ringed is the resistance to the flow calculated in step 7030.

[0130] Subsequently, step 7045 determines the magnitude of the variation in the bandpass filtered signal. Determines whether the magnitude threshold is exceeded. The bandpass filtered signal is bandpass filtered In one run, where the filtered total flow rate Qt' is 10 liters, the size threshold is 10 liters. The value is per minute. Step 7045 is when the variation magnitude of the bandpass filtered signal is large. If it is determined that the size threshold ("N") is not exceeded, method 7000 proceeds to step 7070. Then, it returns a "false" value.

[0131] If not (if the answer is "Y" in step 7045), then method 7000 proceeds , bandpass fill when the slide window whose size is calculated slides forward The tarred signal itself (e.g., the bandpass filtered total flow Qt') This determines whether the magnitude of the fluctuation is significant. Respiratory demand typically changes slowly over time. Therefore, such fluctuations in the magnitude of the bandpass filtered signal The presence of high-flow therapy tends to confirm that it is being used by 1,000 patients. Therefore, step 7050 is performed over a further sliding window of a predetermined duration. This calculates the degree of variation in the cross-pass filtered signal. The further sliding window shows the magnitude of the variation in the bandpass filtered signal. This may have the same duration as the slide window calculated in step 7040. Subsequently, step 7055 is performed to check the variation in the magnitude of the bandpass filtered signal. Determines whether the degree exceeds the magnitude variation threshold. The magnitude variation threshold can be further adjusted. The choice depends on the duration of the window. The longer the sliding window, the smaller the size. A threshold for magnitude variation should be selected. The bandpass filtered signal is bandpass filtered. In one run, the total flow Qt' is filtered by the pass, and further slides are used. The window has a duration of 1 minute, the degree of magnitude variation is dispersed, and the flow rate is large. The fluctuation threshold is 0.002.

[0132] Step 7055 measures the degree of variation in the magnitude of the bandpass filtered signal. If it is determined that the magnitude variation threshold ("N") is not exceeded, method 7000 proceeds to step 7070. Proceed to the next step and return a "false" value indicating that high-flow therapy is not being used by patient 1000. Yes. Otherwise ("Y"), method 7000 proceeds to step 7060, high flow rate. The system returns a value of "true" indicating that the therapy is being used by 1000 patients.

[0133] In another execution of the algorithm for determining the use of high-flow therapy, step 7050 Step 7055 is optional, and therefore, it can be placed immediately after the "Y" answer from step 7045. Step 7060 is performed. Therefore, steps 7050 and 7055 are optional. .

[0134] In another execution of the algorithm for determining the use of high-flow therapy, step 7040 7045 (and optionally 7050 and 7055) are based on the total flow rate Qt. Rather, the resistance to the device pressure Pd or flow calculated in step 7030. This may be done against resistance. In such execution, step 7045 (and where In the case of 7055), different thresholds are applied.

[0135] 8.4.3.2 Monitoring of high-flow therapy In one form of this technology, the monitoring algorithm for high-flow therapy is located at the RT device outlet. The signal shows the pressure Pd and the total airflow Qt delivered from the RT device 4000. It receives signals as input. The monitoring algorithm for high-flow therapy is based on consecutive time points. Generates time-series indicators of the high-flow therapy state as output. The indication can take one of several values. Each indicates a different state of high-flow therapy (e.g., "In use", "Not in use", "Debye"). (Speed ​​failure), "Air circuit blockage," and "Air circuit disconnection." Such conditions indicate The degree (singular or plural) can be stored in memory 426, or it determines the indicator. On the user interface or display of the controller 4230 of the RT device 4000 Controller 4 of RT device 4000 which can output to the display or determine the indicator Output to communicate with 230 or to be displayed on a user interface or display. obtain.

[0136] As mentioned above in relation to the algorithm for determining how to use high-flow therapy, The monitoring algorithm is controlled by the central controller 4230 of RT device 4000, and remote external computers. The processor of the 4286 processing device, or in "real-time" or post-processing. These two constant combinations as processes can be performed. Similarly, high-flow therapy As mentioned above in relation to the algorithm that determines how to use high-flow therapy, The Zoom can store the state indication as a time-series record of the high-flow therapy state. RT device 40 Based on the record of such a state, 00 may take different actions. For example, Depending on the case, the status indicator or the accumulated record of the status indicator may be evaluated in the controller. This can function as a trigger for a change in the operation of the controller 4230 of the RT device 4000. (Example) For the purpose, for example, a sufficient number (e.g., a series) of status indicators indicate non-use, blockage and / or If a connection or disconnection is indicated, the controller 4230 changes the control operation of, for example, the blower motor 4144. This may interrupt treatment (for example, by reducing or reducing flow generation). (This can be stopped). Optionally, for example, if a sufficient number of state indicators (e.g., a series) are blocked, In this case, the controller 4230 may increase the treatment (for example, control of the blower motor). (By changing your actions, you can increase the amount of data generated.)

[0137] Figure 7b shows the algorithm used to implement a high-flow therapy monitoring algorithm according to one embodiment of this technology. A flowchart of possible methods 7100. Below, regarding method 7100, the debug This will be explained using chair pressure Pd. However, if an appropriate threshold is set, method 7100 is It can function effectively using patient interface pressure Pm.

[0138] The steps in Method 7100 and the relative reference numerals in Method 7000 Steps (e.g., 7130 and 7030) are relative references in method 7000 Method 7100 is generally the same as the numbered steps, in that it is as follows: Except for this, it is similar to method 7000.

[0139] The first step 7110 determines whether the device pressure Pd falls below a threshold. If pressure Pd falls below the threshold, it means that pressure generator 4140 is not operating or has malfunctioned. This can occur if ("Y"), then method 7100 proceeds to step 7115. Method 7100 concludes, and the indication value for "device malfunction" is returned. If not ("N"), method 7100 proceeds to steps 7120 and 7130. Proceed to step 7120 and 7130 as described above. It is the same as 030.

[0140] After step 7130, step 7133 is when the resistance to the flow is too small (i.e., In one run, this is equal to 0.4 cmH2O / liter / minute, in step 7035. Check if it is lower than the lower end of the range used in the context. If so ("Y"), Method 7100 proceeds to step 7137, concluding Method 7100 and concerning the indicators. The system returns an indication value for the "connection disconnected" status. This value is not available if the system is not sealed. The patient interface 3800 indicates that it has been disconnected from patient 1000's airway. This reduces the leakage resistance 6140 in circuit model 6100.

[0141] If not ("N" in step 7133), method 7100 proceeds to step 71 Proceed to 38, where the resistance to the flow is too great (i.e., 0.9 cm in one run). Equivalent to H2O / liter / minute, above the upper limit of the range used in step 7035 Check if (y). If so, proceed to step 7139. Method 7100 concludes that the indicator has an indication value of "occlusion" (indication v Return alue). This value indicates that air circuit 4170 may be blocked. If not ("N"), method 7100 proceeds to step 7140. Step 7140 is, This is the same as step 7040 described above.

[0142] In a modified version of Method 7100, after Test 7138, a second test of the value of the resistance to flow An experiment (not shown) is conducted. If this value exceeds the "high" threshold and step 7138 If the value falls below the threshold used, the next step is to indicate that the "cannula is too large." The indication value can be returned, and this indicates that the cannula projection is 1000 patients. This indicates a near-sealed state inside the nose.

[0143] Step 7170 is (for example, if patient 1000 is in a state of prolonged suffocation or if the nasal passages are Test in step 7145 or step 7155 (may occur if there is an obstruction) This can be reached if the test in the step fails. Step 7170 sets the value to "Not Used" in the state. Return the form for verification, indicating that patient 1000 is not using high-flow therapy. Step 7160 is reached when the test in step 7155 is passed, and the value of "In Use" is reached. Return the report to indicate that patient 1000 is using high-flow therapy.

[0144] In a modified version of Method 7100 for Monitoring High-Flow Therapy, "device malfunction," "connection" Return steps 7115, 7137, and 7115 return the "cut" and "blocked" respectively. Instead of step 139, tests may be performed for each of its indicators. For example, step 713 7, instead of returning a "disconnected" status indicator, sends an unsealed patient interface A separate test can be initiated to disconnect the -3800 from patient 1000.

[0145] 8.4.3.3 Circuit Model Calibration Circuit model 6100 has an air circuit, interface, and leakage path with linear resistor 613 Rather than being modeled by 0, 6150, and leakage resistance 6140 respectively, the pressure The force drop depends nonlinearly on the flow rate of air passing through the interior, due to each nonlinear impedance. It can be generalized so that it can be modeled. Characterizing each of these impedances To achieve this, multi-stage calibration may be performed. In each stage, the steady-state device pressure Pd is at least Two different values ​​are applied, and the corresponding measurement of the total flow rate Qt is performed. Using measurement, a polynomial is derived that relates the pressure drop on the impedance to the flow rate passing through the interior. Adjust the following series of calibration steps, each of which adjusts the configuration of the air circuit and The corresponding impedances that can be characterized by this are listed below. The added impedance allows for the next stage of calibration / characterization. • Interface connected to and disconnected from the air circuit: Corresponding to resistor element 6130 Air circuit impedance. • Interface connected to the air circuit and disconnected from the patient: Resistive element Interface impedance compatible with 6150. • Air circuit and interface connected to the patient, patient's "self-occlusion": Leakage impedance corresponding to the 6140 anti-element.

[0146] 8.4.3.4 Estimation of patient parameters An inductor (not shown) in series with these elements and parameters that can be derived from these values (For example, divide the reciprocal of the square root of the product of inertance and compliance by 2π) (Equivalent to the value obtained by dividing the resistance by the inertance by 2π) Lung resonance frequency and (equivalent to the value obtained by dividing the resistance by the inertance by 2π) (Attenuation) Patient parameters (e.g., airway resistance 6125, lung compliance) S6135, the airway "inertance" modeled by circuit model 6100, is estimated. This can be diagnostically interesting. To infer such parameters, 6110 superimposed on its servo control value, as described above, the servo control value is constant. It has more "active" components that vary in the number of breaths per unit time or This can be achieved. The components of this activity include, for example, inputs at a specific frequency or broadband noise. This may include pulses, gradients, and fluctuations. The resulting total flow rate Qt response is compared to the device pressure Pd. By analyzing it together with the components of its activity, we can infer one or more of the above patient parameters. This is generated. Non-patient elements of circuit model 6100 (6130, 6150, and 6140) This process is greatly aided when the system is characterized by calibration as described above.

[0147] 8.4.3.5 Two-nostril model Figure 6c shows high-flow therapy breathing through an unsealed patient interface 3800. An electrical circuit forms an even more advanced model of an RT device to deliver to 1000 patients. This is a circuit diagram of circuit model 6200. Electrical circuit model 6200 is based on electrical circuit model 6100. Each of the relatives inside is the same as 6110, 6120, 6120, 6125, 6130 and 6135. It includes elements 6210, 6220, 6225, 6230 and 6235. However, The Path Model 6200 uses Interface Resistor 6150, which is not sealed to the patient interface. Two separate resistors 625 each model the left and right nasal protrusions of face 3800. Divide into 0a and 6250b. Leakage resistance 6140, and left and right nostril leakage resistance 62 It is divided into 40a and 6240b respectively. The variation of resistors 6260a and 6260b. This models the resistance of the left and right nasal passages, respectively. The total flow rate Qt is calculated by passing through the left protrusion. The flow rate is divided into the Qa flow rate and the Qb flow rate passing through the right projection.

[0148] If nasal passage resistances 6260a and 6260b are extremely low, Model 6200 is simplified. Then, the interface resistor 6150 is equal to the parallel resistors 6250a and 6250b. , Leak resistance 614 equal to parallel left and right nostril leak resistances 6240a and 6240b Let's set the model to 6100 along with 0. However, for example, due to nasal circulation, the nasal passage resistance 6260a The above does not apply if either of the above uses of 6260b is not negligible. The method for determining and monitoring usage is to determine the usage indication and status indication at a given time. It is also applicable to the 2-nostril model 6200, but it can be run with different thresholds than those mentioned above. Yes. However, to characterize individual nostrils and leakage resistance at any given time, Therefore, the multi-stage calibration process described above needs to be made more refined: • Interface connected to and disconnected from the air circuit: Corresponding to resistor element 6230 Air circuit impedance. • Interface connected to the air circuit and disconnected from the patient, right projection closed Blockage: Left projection impedance corresponding to resistive element 6250a. • Interface connected to the air circuit and disconnected from the patient, left projection closed Blockage: Right projection impedance corresponding to resistive element 6250b. • Air circuit and interface connected to the patient, right nostril is "self-obstructed" For the patient: Leakage impedance of the left nostril corresponding to resistive element 6240a. • Air circuit and interface connected to the patient, left nostril is "self-obstructed" Patient: Leakage impedance of the right nostril corresponding to resistance element 6240b.

[0149] After adding the "active" components to source 6110 with each nostril self-obstructed, the active components Analyzing the constituent elements and the resulting total flow rate Qt reveals other factors at any given time. Along with patient parameters, the corresponding resistance elements 6260a and 6260b are provided. This makes it possible to estimate the impedance of the left and right nasal passages.

[0150] 8.5 Humidifier In one form of this technology, the absolute relative of air or gas to the atmosphere for delivery to the patient To change the humidity, a humidifier 5000 (for example, as shown in Figure 5a) is provided. Typically, a humidifier 5000 is used to increase absolute humidity and airflow (into the atmosphere). After increasing the (relative) temperature, delivery to the patient's airway takes place.

[0151] Humidifier 5000 consists of a humidifier reservoir 5110 and a humidifier inlet 500 that receives airflow. 2, and may include a humidifier outlet 5004 for delivering a flow of humidified air. In the form of the humidifier reservoir 5110, as shown in Figures 5a and 5b, The outlets may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The 5000 unit may further include a humidifier base 5006. The humidifier base 5006 is a humidifier The device may be adapted to receive a reservoir 5110 and include a heating element 5240. The humidifier reservoir 5110 may include a conductive part 5120. The conductive part 5120 is To enable effective heat transfer from the heat element 5240 to the volume of liquid in the reservoir 5110 The humidifier reservoir 5110 may include a water level indicator 5150.

[0152] In one embodiment, the humidifier 5000 is configured to receive the humidifier reservoir 5110. It may include a humidifier reservoir dock 5130. In some configurations, the humidifier reservoir The reservoir dock 5130 holds the reservoir 5110 inside the humidifier reservoir dock 5130. It may include locking features such as a locking lever 5135 configured to do so.

[0153] 8.6 Glossary For the purpose of disclosing this technology, in a specific form of this technology, one or more of the following definitions apply. It may be applicable. In other forms of this technology, other definitions may also be applicable.

[0154] 8.6.1 General Air: In certain forms of this technology, air may mean the atmosphere, and in other forms of this technology... And air means a combination of other breathable gases (for example, the atmosphere, which is rich in oxygen). It is possible.

[0155] Respiratory pressure therapy: Applying a continuously positive therapeutic pressure to the airway entrance. To deliver.

[0156] Continuous positive airway pressure (CPAP) therapy: The therapeutic pressure is maintained throughout the patient's respiratory cycle. Respiratory pressure therapy is a nearly constant therapy. In some forms, the pressure at the entrance to the airway is constant during exhalation. It rises slightly at times and decreases slightly during inhalation. In some forms, the pressure is , which fluctuates between different respiratory cycles in the patient (e.g., the degree of partial upper airway obstruction) (Increased in response to detection of partial upper airway obstruction, and reduced in the absence of indications of partial upper airway obstruction.) .

[0157] Patient: A person who has or does not have a respiratory illness.

[0158] Automatic positive airway pressure (APAP) therapy: Depending on the presence or absence of indications of SDB onset. For example, C allows for continuous adjustment of therapeutic pressure between the minimum and maximum limits during respiration. PAP therapy.

[0159] 8.6.2 Phases of the Respiratory Cycle Choking: According to some definitions, choking is when a flow falls below a certain threshold for, for example, 10 seconds. It is said to occur when it persists over an intermittent period. Interferential asphyxiation is when the patient is struggling It refers to a condition where, despite exerting force, the airway is obstructed and air cannot flow. Central apnea is a condition in which the airway is open but respiratory effort is reduced or respiratory failure occurs. It is said to refer to a condition in which suffocation is detected due to the absence of respiratory effort. Mixed suffocation refers to a condition in which respiratory effort It is said to refer to a condition in which reduced or absent airway strength occurs simultaneously with airway obstruction.

[0160] Respiratory rate per unit time: The patient's spontaneous respiratory rate per unit time. Usually per minute. It is measured by the number of breaths.

[0161] Duty cycle: The ratio of inhalation time Ti to total breathing time Ttot.

[0162] Breathing Effort: Breathing effort is the movement performed by a person's spontaneous breathing. It is said to refer to this.

[0163] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0164] Flow restriction: Flow restriction occurs when the patient's respiratory flow does not increase even when the patient makes increased efforts. This refers to the inhalation condition. If flow restriction occurs during the inspiratory portion of the breathing cycle, then the flow... This restriction can be described as an inspiratory flow restriction. Flow restriction in the expiratory portion of the respiratory cycle If this occurs, the flow restriction may be described as an exhalation flow restriction.

[0165] Decreased respiration: Preferably, decreased respiration means a reduction in flow, not an interruption of flow. Form 1 In this state, if the flow rate drops below the threshold velocity and continues for a period of time, respiratory depression will occur. It is said to have occurred. If respiratory depression is detected due to a decrease in respiratory effort, central respiration A decline is said to have occurred. If any of the following occurs in a particular form of adulthood, This may be considered respiratory depression: (i) A 30% decrease in patient respiration lasting at least 10 seconds + associated 4% desaturation, or; (ii) A decrease in patient respiration (less than 50%) that lasts for at least 10 seconds and associated desaturation. The probability is at least 3%, or an awakening occurs.

[0166] Hyperventilation: A condition in which blood flow increases to a level higher than normal.

[0167] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the inspiratory flow is the respiratory cycle It is used as the intake part of the engine.

[0168] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency can be quantified by one of the following values: (1) airway is open. The value is zero (0), when it is closed (obstructed).

[0169] Positive End-of-Expiratory Pressure (PEEP): This is the pressure that exceeds the atmospheric pressure in the lungs at the end of exhalation. To exist.

[0170] Peak flow rate (Q peak): The maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0171] Respiratory flow rate, airflow rate, patient airflow rate, respiratory airflow rate (Qr): These are synonymous terms. This can be understood as referring to an estimate of the respiratory air flow rate of an RT device, usually expressed in liters / minute. In contrast to the patient's actual respiratory flow rate, which is called "true respiratory flow" or "true respiratory airflow". It is used.

[0172] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort. This is the amount of air that was released.

[0173] (Inhalation) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0174] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0175] (Total) time (Ttot): From the start of the inspiratory portion of one respiratory flow waveform to the start of the next respiratory flow waveform. The total duration between the start of the intake portion and the start of the intake portion.

[0176] Typical recent ventilation: Ventilation values ​​where recent values ​​tend to cluster together over a given time scale ( In other words, the degree of the trend of the most recent central value of ventilation.

[0177] Superior airway obstruction (UAO): Includes both partial and total superior airway obstruction. The flow level increases slightly along with the increase in the pressure difference over the lateral airway (Stirling register behavior). This may be associated with flow limiting conditions that may cause or reduce flow limits.

[0178] Ventilation (ventilation): The degree to which the total amount of gas exchanged by the patient's respiratory system is measured. This may include one or both of the inspiratory and expiratory airflows per unit time. Per minute When expressed as a quantity, this number is often called "ventilation rate per minute." While the quantity may sometimes be given simply as a number, it is generally understood as the quantity per minute.

[0179] 8.6.3 RT Device Parameters Flow rate: The instantaneous amount (or mass) of air delivered per unit time. (Simplified "flow rate") (Sometimes referred to simply as "flow"). Flow rate and ventilation are defined as the amount of the same size per unit time. While some substances have mass, flow rates are measured over a much shorter time. In some cases, regarding flow rates... When mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). And when referring to flow rate, it means a vector quantity (i.e., both magnitude and direction). (The amount held). When referred to as a signed quantity, the flow rate is the inspiratory portion of the patient's respiratory cycle. Since it can be nominally positive with respect to the expiratory portion of the patient's respiratory cycle, it is negative with respect to the expiratory portion. The total flow rate Qt is the flow rate of air delivered from the RT device.

[0180] Pressure: Force per unit area. Pressure can be measured in units within a certain range (e.g., cmH). 20, gf / cm 2 , hectopascals. 1 cmH2O is 1 g-f / cm³ 2 Equivalent to, (Approximately 0.98 hectopascals). In this specification, unless otherwise specified, pressure is Pressure within the patient interface (patient interface) is given in units of cmH2O. Face pressure) is indicated by the symbol Pm, and is the pressure at the outlet of the RT device (device pressure). Pressure is indicated by the symbol Pd.

[0181] 8.7 Other Notes Some of the disclosures in this patent document include content that is protected by copyright. The copyright holder is... Even if a person reproduces this patent document or this patent disclosure by fax, the patent file of the Japan Patent Office I have no objection to anything that is recorded in the log or in the records for the purpose, but for other purposes We retain all copyrights to this matter.

[0182] Unless otherwise clearly indicated by the context and a range of values ​​is provided, the lower limit is 1 / 10 of the unit, between the upper and lower limits of the range, and any other specified value within the range. It is understood that each intervention value relative to the intervention value is included in this technology. Independent within the intervention range The upper and lower limits of the scope of these interventions specifically include exceeding the limits within the stated scope. This is also included in the Technology. In addition, the scope of this technology extends beyond any or both of the limitations described herein.

[0183] Furthermore, if a value (one or more) is used in this specification as part of the technique, other Unless otherwise specified, such values ​​may be approximated and are permissible or required by practical technical implementation. It is understood that such values ​​can be used up to any appropriate number of significant digits within the given range.

[0184] Unless otherwise specified, all technical and scientific terms in this specification belong to the category of the technology to which this technology belongs. It has the same meaning as that generally understood by those skilled in the field. Any method and materials similar to or equivalent to those used in the practice or testing of this technology may not be used. While it is possible to use them in this way, only a limited number of exemplary methods and materials are described herein. It will be done.

[0185] Although certain materials are described as being suitable for construction of components, their properties are Similar, obvious alternative materials are used as substitutes. Furthermore, conversely, if not specified To the extent that any and all components described herein are understood to be manufacturable, Therefore, they can be manufactured collectively or individually.

[0186] As used herein, in the attached claims, the singular form "a" "An" and "the" include their plural equivalents unless the context makes it clear. Please note the following points.

[0187] All published documents mentioned herein are the methods and / Or, disclosure and description of materials, and reference thereof. The published documents mentioned herein are and provided solely for the purposes of disclosure prior to the filing date of this application. The content of this document also acknowledges that this technology does not precede such published documents due to prior patents. It should not be interpreted as such. Furthermore, the dates of the published documents listed are the actual dates of the published documents. This may differ, and individual verification may be necessary.

[0188] Furthermore, in the interpretation of this disclosure, all terms are given in the most reasonable way possible, based on the context. It should be interpreted as a formula. For details, see "comprises" and "compris The term "ing" refers exclusively to an element, component, or step. It should be interpreted in this way, and other elements, components, or steps that are not explicitly stated. Indicates that an element, component, or step may exist, be used, or be combined with it.

[0189] The headings used in the detailed explanation are for the convenience of the reader and do not apply to this disclosure. It should not be used to limit what is found in the entire scope of the patent claims. These headings are used in the interpretation of the scope of the claims or limitations on the claims. It should not be used in that way.

[0190] Although the technologies described herein have been described with reference to specific embodiments, these embodiments It should be understood that the examples provided merely illustrate the principles and applications of this technology. In some cases, terms and symbols may indicate specific details that are not necessary for the implementation of this technology. For example, the terms "first" and "second" are used, but unless otherwise specified, These terms are not intended to indicate any particular order, but rather to distinguish distinct elements. It is possible. Furthermore, the description or examples of process steps in this method are ordered. Although it may be stated in this order, such an order is unnecessary. A person skilled in the art would know this order. The order can be changed and / or the phases can be performed simultaneously or even synchronously. Recognize that this is the case.

[0191] Therefore, it should be understood that numerous modifications are possible in the exemplary examples, and that other configurations may be devised, without deviating from the intent and scope of this technology. The original claims of the parent application are as follows: Claim 1: A method for determining whether high-flow therapy is being used by a patient, wherein the method is: By evaluating one or more signals in a controller associated with a respiratory therapy device, the one or more signals from one or more sensors are determined, and it is determined whether the characteristics of the airflow delivered from the respiratory therapy device along the air circuit to an unsealed patient interface include significant variations within a band of respiratory rate per unit time. A method comprising, based on the determination, generating an output indication in the controller indicating whether high-flow therapy is being used by the patient. Claim 2: The method according to claim 1, wherein generating the output indicator indicating that high-flow therapy is being used by the patient is generated when it is determined that the characteristic includes a significant variation within the band of respiratory rate per unit time. Claim 3: The above decision is: Calculating the magnitude of the variation in the respiratory rate per unit time within the bandwidth of the signal exhibiting the characteristics over a predetermined duration window, The method according to claim 1, comprising determining whether the magnitude of the fluctuation is greater than a magnitude threshold. Claim 4: The method according to claim 3, wherein the calculation involves applying to the signal a bandpass filter having cutoff counts that are approximate upper and lower limits of the respiratory rate per unit time of a resting human. Claim 5: The method according to claim 4, wherein the magnitude of the variation is the standard deviation of the window. Claim 6: The method according to claim 3, wherein the calculation includes calculating the power of the Fourier transform spectrum of the signal on the window within the band of respiratory rate per unit time. Claim 7: The method according to claim 3, further comprising determining whether the magnitude of the fluctuation of the signal changes significantly as the window slides forward, and the generation further based on the determination. Claim 8: The method of claim 7, wherein, when it is determined that the magnitude of the variation has changed significantly when the window slides forward, the generating generates the output indicator indicating that high-flow therapy is being used by the patient. Claim 9: The above decision is: Calculating the degree of variation in the magnitude of the said variation over a further window of a predetermined duration, The method according to claim 7, comprising determining whether the degree of the variation is greater than a magnitude variation threshold. Claim 10: The method according to claim 9, wherein the degree of variation is the variance. Claim 11: The method according to any one of claims 1 to 10, wherein the characteristic of the airflow is the total flow rate of the airflow. Claim 12: The method according to any one of claims 1 to 10, further comprising calculating the resistance to flow from the total flow rate of the airflow and the pressure of the airflow. Claim 13: The method according to claim 12, wherein the characteristic of the airflow is resistance to the flow. Claim 14: The method further includes determining whether the resistance to the flow is within a predetermined range. The method according to claim 12, wherein generating is further based on determining. Claim 15: The method of claim 14, wherein, if it is determined that the resistance to the flow is not within the predetermined range, the generating generates the output indicator indicating that high-flow therapy is not being used by the patient. Claim 16: The method according to claim 14, wherein if it is determined that the resistance to the flow is below the lower limit of the predetermined range, the generating generates the output indicator indicating that the air circuit is connected or disconnected. Claim 17: The method according to claim 14, wherein if it is determined that the resistance to the flow exceeds the upper limit of the predetermined range, the generating generates the output indicator indicating that the air circuit is blocked. Claim 18: The method according to claim 14, further comprising the controller generating an output indication that the patient interface is too large based on the determination that the resistance to the flow exceeds the upper limit of the predetermined range. Claim 19: The above calculation is: Applying a bandpass filter having a cutoff frequency that is the approximate upper and lower limits of the respiratory rate per unit time for a human at rest to the total flow rate and the pressure to generate a bandpass filtered device pressure and a bandpass filtered total flow rate, The method according to claim 12, comprising dividing the bandpass filtered device pressure by the total bandpass filtered flow rate. Claim 20: The method according to claim 19, wherein the pressure is the pressure at the outlet of the respiratory therapy device. Claim 21: The generation of the output indicators is repeated to generate multiple generated output indicators for the use of high-flow therapy, The method according to any one of claims 1 to 20, further comprising storing the time-series generated output indicators of the use of the high-flow therapy in a record of the patient's time-series use of the high-flow therapy. Claim 22: The method according to claim 21, further comprising generating a compliance report based on the record of how the high-flow therapy was used. Claim 23: The method according to claim 21, further comprising adjusting the parameters of the high-flow therapy based on the record of how the high-flow therapy was used. Claim 24: The method according to claim 23, wherein the parameter is the therapeutic flow rate. Claim 25: The method according to claim 21, further comprising generating a warning based on the record of how the high-flow therapy was used. Claim 26: The method according to any one of claims 1 to 25, further comprising comparing the characteristics of the airflow with a threshold, wherein the generation is further based on the determination. Claim 27: The method according to claim 26, wherein the characteristic is the total flow rate of the airflow, and the generating is the generation of an output indication that high-flow therapy is not being used by the patient if it is determined that the total flow rate is less than a flow rate threshold. Claim 28: The method according to claim 26, wherein the characteristic is the pressure of the airflow, and the generating is the generation of an output indication that the respiratory therapy device is not operating if it is determined that the pressure is below a pressure threshold. Claim 29: The method according to any one of claims 1 to 28, further comprising estimating the number of breaths per unit time from a signal exhibiting the aforementioned characteristics. Claim 30: Claims 1 to 1 further include controlling changes in the operation of the respiratory therapy device based on the output indication of whether high-flow therapy is being used by the patient. The method described in any one of the 29 methods. Claim 31: The method according to claim 30, wherein the characteristics of the airflow delivered from the respiratory therapy device are changed due to a change in the operation of the respiratory therapy device. Claim 32: A device for delivering high-flow therapy to a patient, wherein the device: A servo-controlled blower configured to generate airflow along the air circuit to an unsealed patient interface; A central controller configured to control the servo-controlled blower; One or more transducers configured to generate one or more signals representing each of the characteristics of the generated airflow; It is a processor: Receiving one or more of the aforementioned signals; Controlling the determination of whether the characteristics of the airflow indicated by one or more of the aforementioned signals include significant variation within a band of respiratory rate per unit time; and Apparatus including a processor configured to generate an indication of whether high-flow therapy is being used by the patient in accordance with the aforementioned determination. Claim 33: The method according to claim 32, wherein the processor is the central controller. Claim 34: The method according to claim 32, wherein the processor is located in a remote external computing device configured to communicate with the central controller. Claim 35: A device for delivering high-flow therapy to a patient, wherein the device: Flow means for generating airflow along an air circuit to an unsealed patient interface; means for controlling the flow means; means for generating one or more signals that represent each characteristic of the generated airflow; means for receiving one or more signals; Means for determining whether the characteristics of the airflow indicated by one or more of the aforementioned signals include significant variation within a band of respiratory rate per unit time; Apparatus comprising means for generating an indication of whether high-flow therapy is being used by the patient in accordance with the aforementioned determination. Claim 36: A high-flow therapy system, which includes: With an unsealed patient interface; An air circuit configured to connect to the aforementioned unsealed patient interface; A servo-controlled blower configured to generate airflow along an air circuit; A central controller configured to control the servo-controlled blower; One or more transducers configured to generate one or more signals representing each of the characteristics of the generated airflow; It is a processor: Receiving one or more of the aforementioned signals; Controlling the determination of whether the characteristics of the airflow indicated by one or more of the aforementioned signals include significant variation within a band of respiratory rate per unit time; and A system including a processor configured to generate an indication of whether high-flow therapy is being used by the patient in accordance with the aforementioned determination. [Explanation of Symbols]

[0192] patient 1000 Sleeping companion 1100 Patient Interface 3000 Closed formation structure 3100 Cavity room 3200 Structure 3300 Ventilation holes 3400 Connection port 3600 Forehead support part 3700 Unsealed patient interface 3800 nasal protrusion 3810 nasal protrusion 3810 Lumens: 3820 Lumens: 3820 RT Device 4000 External housing 4010 Upper part 4012 Part 4014 Panel 4015 Chassis 4016 Handle 4018 Pneumatic block 4020 Pneumatic component 4100 Air filter 4110 Inlet air filter 4112 Outlet air filter 4114 Entrance muffler 4122 Exhaust muffler 4124 Pressure generator 4140 Blower 4142 Motor 4144 Air circuit 4170 Additional oxygen 4180 Electrical components 4200 Printed circuit board assembly 4202 power supply 4210 Input device 4220 Central controller 4230 Clock 4232 Therapy device controller 4240 Protection circuit 4250 Memory 4260 Transducer 4270 Pressure sensor 4272 Flow transducer 4274 Motor speed transducer 4276 Data communication interface 4280 Remote external communication network 4282 Local external communication network 4284 Remote external computing device 4286 Local external device 4288 Output device 4290 Display driver 4292 Display 4294 Algorithm 4300 Therapy control module 4330 Humidifier 5000 Humidifier inlet 5002 Humidifier outlet 5004 Humidifier base 5006 Humidifier reservoir 5110 Conductive part 5120 Humidifier reservoir dock 5130 Lock lever 5135 Water level indicator 5150 heating element 5240 Humidifier controller 5250 Electrical circuit model 6000 Voltage source 6010 AC voltage source 6020 Airway resistance 6025 Air circuit resistance 6030 Lung compliance 6035 Interface resistor 6050 Electrical circuit 6100 Voltage source 6110 AC voltage source 6120 Airway resistance 6125 Air circuit resistance 6130 Lung compliance 6135 Leakage resistance 6140 Interface resistor 6150 Electrical circuit 6200 Voltage source 6210 AC voltage source 6220 Airway resistance 6225 Air circuit resistance 6230 Lung compliance 6235 Left nostril leakage impedance 6240a Right nostril leakage impedance 6240b Left projection impedance 6250a Right projection impedance 6250b Left nasal passage impedance 6260a Right nasal passage impedance 6260b method 7000 Step 7010 Step 7020 Step 7030 Step 7035 Step 7040 Step 7045 Step 7050 Step 7055 Step 7060 Step 7070 Method 7100 Step 7110 Step 7115 Step 7120 Step 7130 Step 7133 Step 7137 Step 7138 Step 7139 Step 7140 Step 7145 Step 7155 Step 7160 Step 7170

Claims

1. A method for determining whether high-flow therapy is being used by a patient, By evaluating one or more signals in a controller associated with a respiratory therapy device, the one or more signals from one or more sensors are determined, and it is determined whether the characteristics of the airflow delivered from the respiratory therapy device along the air circuit to an unsealed patient interface include significant variations within a band of respiratory rate per unit time, Based on the determination of whether the characteristics of the airflow include significant fluctuations, the controller generates an output indication of whether high-flow therapy is being used by the patient. Includes, Here, the decision to make the above decision is: The controller calculates the magnitude of the variation in the frequency per unit time within the bandwidth of the signal exhibiting the characteristics over a predetermined duration window, The controller determines whether the magnitude of the aforementioned fluctuation is greater than the magnitude threshold, It includes, A method for calculating the magnitude of the variation, comprising (a) calculating the standard deviation of the signal across the window, or (b) the power of the Fourier transform spectrum of the signal across the window within the band of respiratory rate per unit time.

2. The method according to claim 1, wherein generating the output indicator indicating that high-flow therapy is being used by the patient is generated when it is determined that the characteristics include significant variation within the band of respiratory rate per unit time.

3. The method according to claim 1, wherein calculating the magnitude of the fluctuations involves applying a bandpass filter to the signal, the bandpass filter having cutoff counts that are approximate upper and lower limits of the respiratory rate per unit time of a resting human.

4. The method according to claim 1, wherein the window is a sliding window that slides forward, and further comprises determining whether the magnitude of the fluctuation of the signal changes significantly as the window slides forward, and the generation further depends on the determination of whether the magnitude of the fluctuation of the signal changes significantly as the window slides forward.

5. The method of claim 4, wherein, when it is determined that the magnitude of the variation has changed significantly when the window slides forward, the generating generates the output indicator indicating that high-flow therapy is being used by the patient.

6. The determination of whether the magnitude of the fluctuation of the signal changes significantly when the window slides forward is: Calculating the degree of variation in the magnitude of the said variation over a further window of a predetermined duration, To determine whether the degree of the aforementioned variation is greater than the magnitude variation threshold. The method according to claim 4, including the method described in claim 4.

7. The method according to any one of claims 1 to 6, wherein the characteristic of the airflow is the total flow rate of the airflow.

8. The method according to any one of claims 1 to 6, further comprising calculating the resistance to flow from the total flow rate of the airflow and the pressure of the airflow.

9. The method according to claim 8, wherein the characteristic of the airflow is resistance to the flow.

10. The method further includes determining whether the resistance to the flow is within a predetermined range. The method according to claim 8, wherein the generation is further based on the determination of whether the resistance to the flow is within a predetermined range.

11. The method of claim 10, wherein, if it is determined that the resistance to the flow is not within the predetermined range, the generating generates the output indicator indicating that high-flow therapy is not being used by the patient.

12. The method according to claim 10, wherein if it is determined that the resistance to the flow is below the lower limit of the predetermined range, the generating generates the output indicator indicating that the air circuit is connected or disconnected.

13. The method according to claim 10, wherein if it is determined that the resistance to the flow exceeds the upper limit of the predetermined range, the generating is to generate the output indicator indicating that the air circuit is blocked.

14. The method according to claim 10, further comprising the controller generating an output indication that the patient interface is too large, based on the determination that the resistance to the flow is within the predetermined range, if it is determined that the resistance to the flow exceeds the upper limit of the predetermined range.

15. The above calculation is performed by Applying a bandpass filter having a cutoff frequency that is the approximate upper and lower limits of the respiratory rate per unit time for a human at rest to the total flow rate and the pressure to generate a bandpass filtered device pressure and a bandpass filtered total flow rate, The bandpass filtered device pressure is divided by the bandpass filtered total flow rate. The method according to claim 8, including the method described in claim 8.

16. The method according to claim 18, wherein the pressure is the pressure at the outlet of the respiratory therapy device.

17. By repeating the above generation, multiple output indicators are generated to show whether high-flow therapy is being used by the patient. The generated output readings are stored chronologically as a record of the patient's time-series use of the high-flow therapy. A method according to any one of claims 1 to 16, further comprising:

18. The method of claim 17, further comprising generating a compliance report based on the record of the use of the high-flow therapy.

19. The method according to claim 17, further comprising generating a warning based on the record of the use of the high-flow therapy.

20. The method according to any one of claims 1 to 19, further comprising comparing the characteristics of the airflow with a threshold, wherein the generation is further based on the comparison.

21. The method according to claim 20, wherein the characteristic is the total flow rate of the airflow, and the generating is the generation of an output indication that high-flow therapy is not being used by the patient if it is determined that the total flow rate is less than a flow rate threshold.

22. The method according to claim 20, wherein the characteristic is the pressure of the airflow, and the generating is the generation of an output indication that the respiratory therapy device is not operating when it is determined that the pressure is below a pressure threshold.

23. The method according to any one of claims 1 to 22, further comprising estimating the number of breaths per unit time from the signal exhibiting the aforementioned characteristics.

24. The method according to any one of claims 1 to 23, further comprising controlling changes in the operation of the respiratory therapy device based on the output indication of whether high-flow therapy is being used by the patient, using the controller.

25. The method according to claim 24, wherein the characteristics of the airflow delivered from the respiratory therapy device are changed due to a change in the operation of the respiratory therapy device.

26. A device for delivering high-flow therapy to a patient, A servo-controlled blower configured to generate airflow along an air circuit to an unsealed patient interface, A central controller configured to control the servo-controlled blower, One or more transducers configured to generate one or more signals representing each of the characteristics of the generated airflow, A processor configured to receive one or more signals, control a determination of whether the characteristics of the airflow indicated by one of the one or more signals include significant variation within a band of respiratory rate per unit time, and generate an indication of whether high-flow therapy is being used by the patient in accordance with the determination, The determination includes calculating the magnitude of the variation in the frequency per unit time within a band of the signal exhibiting the characteristic over a predetermined duration window, and determining whether the magnitude of the variation is greater than a magnitude threshold. Calculating the magnitude of the variation includes calculating either (a) the standard deviation of the signal across the window, or (b) the power of the Fourier transform spectrum of the signal across the window within the bandwidth of the number of breaths per unit time, and a processor A device that includes this.

27. The method according to claim 26, wherein the processor is the central controller.

28. The method according to claim 26, wherein the processor is located in a remote external computing device configured to communicate with the central controller.

29. A device for delivering high-flow therapy to a patient, A flow means for generating airflow along an air circuit to an unsealed patient interface, Means for controlling the flow means, means for generating one or more signals that represent each characteristic of the generated airflow, means for receiving one or more signals, Means for determining whether the characteristics of the airflow indicated by one of the one or more signals include significant fluctuations within a band of respiratory rate per unit time, The means for generating an indication of whether high-flow therapy is being used by the patient, depending on the determination of whether the characteristics of the airflow include significant fluctuations, The means for determining the above includes calculating the magnitude of the variation in the frequency of respiration per unit time of the signal exhibiting the characteristic over a predetermined duration window, and determining whether the magnitude of the variation is greater than a magnitude threshold. An apparatus for calculating the magnitude of the fluctuations, comprising (a) calculating the standard deviation of the signal across the window, or (b) the power of the Fourier transform spectrum of the signal across the window within the band of respiratory rate per unit time.

30. A high-flow therapy system, An unsealed patient interface, An air circuit configured to be connected to the patient interface, A servo-controlled blower configured to generate airflow along the air circuit, A central controller configured to control the servo-controlled blower, One or more transducers configured to generate one or more signals representing each of the characteristics of the generated airflow, A processor configured to receive one or more signals, control a determination of whether the characteristics of the airflow indicated by one of the one or more signals include significant variation within a band of respiratory rate per unit time, and generate an indication of whether high-flow therapy is being used by the patient in accordance with the determination, The determination includes calculating the magnitude of the variation in the frequency per unit time within a band of the signal exhibiting the characteristic over a predetermined duration window, and determining whether the magnitude of the variation is greater than a magnitude threshold. A processor that calculates the magnitude of the fluctuations, which includes (a) calculating the standard deviation of the signal across the window, or (b) the power of the Fourier transform spectrum of the signal across the window within the bandwidth of the number of breaths per unit time. A system that includes this.

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