Method of determining whether high flow therapy device is being used on patient, device for delivering high flow therapy to patient, and 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 is a continuation of Australian Provisional Application No. 2015900 filed on 13 March 2015. No. 6,200,336, filed on Oct. 13, 2003, and claims the benefit of US Pat. No. 6,200,336, filed on Oct. 1, 2003, the disclosure of which is incorporated herein by reference in its entirety.

[0002] 2 STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable

[0003] 3. Name of organization for joint research and development Not applicable

[0004] 4. Sequence Listing Not applicable

[0005] [Field of the Invention] The technology relates to one or more of the detection, diagnosis, treatment, prevention, and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus or uses thereof. [Background technology]

[0006] 5.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and oral cavity form the entrance to a patient's airways. do.

[0007] These airways contain a series of branching tubes that narrow as they progress deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood. The trachea divides into the right and left main bronchi, which The main bronchi divide further and finally become the terminal bronchioles. The airways are divided into respiratory tracts and do not participate in gas exchange. These become the bronchi and finally the alveoli. Gas exchange occurs in the alveolar region of the lungs. This is called the breathing zone. See: Respiratory Physiol John B. West, Lippincott Willia ms & Wilkins, 9th edition published 2011 .

[0008] A range of respiratory disorders exists. Certain disorders are characterized by specific episodes (e.g., apnea, respiratory It may be characterized by hypopnea and hyperpnea.

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) that affects It is characterized by episodes of obstruction or closure of the upper airway during sleep. A combination of normal deficiencies in muscle tone in the upper airway and tongue region, the soft palate and the posterior oropharyngeal wall. This condition causes the patient to stop breathing, typically for 30 to 120 seconds. The patient stops breathing for periods of time, sometimes 200 to 300 times a night, resulting in daytime sleepiness. In excess, it can lead to cardiovascular disease and brain damage. This condition is a common disorder. It is common in middle-aged, overweight men, but patients do not experience any symptoms. See issue 10 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. It is a disorder of the respiratory control system in people with chronic respiratory distress syndrome, characterized by alternating waxing and waning of ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. Some people experience frequent awakenings from sleep related to CSR, which can lead to severe insomnia and increased sympathetic nervous activity. and afterload increases. nes).

[0011] Chronic obstructive pulmonary disease (COPD) is a group of lower airway diseases that share certain common characteristics. Such characteristics include increased resistance to air movement, There is an increase in the expiratory phase and a loss of the normal elasticity of the lungs. Examples of COPD include emphysema and chronic obstructive pulmonary disease. The causes of COPD include chronic smoking (the primary risk factor), occupational exposure, Air pollution and genetic factors are the causes. Symptoms include shortness of breath on exertion, chronic cough and sputum production. There is a success.

[0012] A range of treatments are available to treat or ameliorate such conditions. Additionally, otherwise healthy individuals can also benefit from preventative treatments for respiratory diseases. However, these suffer from several deficiencies.

[0013] 5.2.2 Respiratory treatment Respiratory pressure therapy (e.g., nasal continuous positive airway pressure (CPAP) therapy) can be used to treat obstructive sleep apnea. It is used in the treatment of OSA. Its mechanism of action includes, for example, the soft palate and By pushing the tongue forward or backward against the posterior oropharyngeal wall, nasal continuous positive airway pressure is released. It acts as an air splint, thus preventing the upper airway from closing.

[0014] Compared to respiratory pressure therapy, high flow therapy (HFT) requires a sealed patient interface. Rather than relying on positive airway pressure being delivered to the source, the device is sealed with a large opening to the atmosphere. Proximity to the entrance(s) to the patient airway via an unprotected patient interface High-flow therapy is used to treat OSA, CSR, and C. It is used in the treatment of OPD. The hypothesized mechanism of action is that it inhibits the airway flow at high flow rates. Air delivered to the ventilator bleeds out of the patient's anatomical dead space, reducing the amount of rebreathed CO2. , thereby increasing the efficiency of gas exchange.

[0015] The range of high flow rates delivered is about 0-120 liters per minute, preferably about 0-75 liters per minute. / min, more preferably from about 0 to about 5 to provide comfort and effectiveness and reduce rebreathing 0 liters / minute, with a preferred range being about 10 to about 35 liters / minute.

[0016] The delivery air temperature may range from about 0° C. to about 50° C., more preferably from about +4° C. to about +45° C. °C range, and even more preferably at room temperature up to 40 °C, to ensure comfort and efficacy. For providing the above, the most suitable range may be 30°C to 37°C.

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

[0018] Regarding high flow therapy, an international patent application was filed on May 28, 2009, PCT / AU09 / 00 No. 671, filed on Dec. 23, 2011. High-flow therapy is used in conjunction with respiratory pressure therapy. It can be done.

[0019] 5.2.3 Treatment system The respiratory therapy may be provided by a therapy system or device. RT devices, air circuits, humidifiers, patient interfaces, and data This may include management.

[0020] 5.2.3.1 Patient interface The patient interface may, for example, provide airflow to the airway inlet to aid in the respiratory The airflow can be used to provide the wearer with an interface to the nasal and and / or via a mask into the mouth, a tube into the mouth, or a tracheostomy tube into the patient's trachea Depending on the therapy being applied, the patient interface may be, for example, This allows for sufficient dispersion of pressure along with atmospheric pressure for therapy to take place. (e.g., at a positive pressure of about 10 cmH2O relative to atmospheric pressure) The sealed interface provides for 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 be non-sealed (i.e., it may not have a seal with the airway entrance). Airflow may be provided through a nasal cannula, a tube into the mouth, or a patient airway. This type of non-sealed patient interface may be provided via a tracheotomy tube to the endotracheal tube. When used in conjunction with high-flow therapy, the interstitial Air escapes through the gap between the face and the patient's nostrils. Under such conditions, In the cannula, a pressure controlled environment (e.g., between the patient and the cannula interface) is provided. Lack of sensing or detection associated with the use of a patient's therapy and / or the patient's breathing Therefore, the embodiment of the present technology is different from the conventional sensor. This was done to overcome the difficulty of obtaining metrics for such therapy while using a obtain.

[0021] 5.2.3.2 Respiratory Therapy (RT) Devices Air pressure generators are known in a range of applications, including industrial scale ventilation systems. However, air pressure generators for medical applications have specific requirements that cannot be met by more general air pressure generators. There are requirements for medical devices (e.g., reliability, size and weight requirements). If a device designed for an application has deficiencies in one or more of the following: These 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 Another example of an RT device is the S9 Sleep Therapy System manufactured by Imitated. ResMed Stellar is a registered trademark of ResMed, a ventilator for adults and children. Ventilators such as the CSR (Registered Trademark) series are designed to operate in multiple states (for example, but not limited to, CSR and Invasive and non-invasive independent replacement therapy for a range of patients for the treatment of COPD and COPD It may provide mental support.

[0023] RT devices typically include a pressure generator (e.g., a motor-driven blower or compressed gas reservoir). The RT device includes an outlet for the RT device and is configured to deliver a flow of air to the patient's airway. is connected via a pneumatic circuit to a patient interface as described above.

[0024] 5.2.3.3 Humidifier Delivery of airflow without humidification can lead to drying of the airways. When used with T devices and patient interfaces, humidified gas is generated, Drying of the nasal and / or throat mucosa is minimized, increasing patient airway comfort. In cold weather, the patient interface and surrounding areas are used to provide warm air to the face. A range of artificial humidification devices and systems are available. Although known systems exist, they do not meet the special requirements of medical humidifiers.

[0025] 5.2.3.4 Data Management Whether patients who are prescribed respiratory therapy are “compliant” (e.g., whether patients The patient is responsible for managing their own RT devices in accordance with certain “compliance rules” related to supported respiratory therapy. There may be clinical reasons for obtaining data to determine whether One example of a CPAP therapy compliance rule is that patients must be compliant. To be considered a patient, the patient must have had the RT device for at least 21-30 consecutive days. Use of the RT device for at least 4 hours per night is required. Similar compliance rules may be implemented when determining patient compliance. To this end, RT device providers (e.g., healthcare providers) must provide Descriptive therapy data is obtained manually using an RT device over a period of time. Usage can be estimated / calculated and compared to compliance rules. A healthcare provider determines that a patient used an RT device in accordance with compliance regulations After the patient has been diagnosed with a medical condition, the health care provider may provide a medical record to a third party (e.g., insurance company) to Compliance notifications may be sent to third parties or external There may be other aspects of a patient's therapy that benefit from communication to an external system. do.

[0026] When a patient uses their RT device to deliver CPAP therapy or other respiratory pressure therapy There are conventional methods for analyzing therapy data to determine Due to the different air pressures of high-flow therapy due to the uncharacterized nature of such methods, When used to determine which RT devices were being used to deliver high-flow therapy, the results showed Therefore, when or if the RT device is being used for high-flow therapy, What is needed is a method and apparatus for determining when a device has been disconnected. Summary of the Invention

[0027] 6. Brief summary of the technique The present technology is directed to the development of medical devices for use in the diagnosis, amelioration, treatment or prevention of respiratory disorders. In relation to delivery, these medical devices offer improved comfort, cost, effectiveness, ease of use and and manufacturability.

[0028] Generally, the present technology relates to a device for use in diagnosing, ameliorating, treating or preventing a respiratory disorder. and methods.

[0029] One form of the technology may be to determine whether a patient is using high-flow therapy based on flow and / or pressure signals. These devices and methods include those that determine whether a device is in use or has been used. The method is based on significant changes in the bandwidth of the respiratory rate per unit time in one or more of these signals. The patient's movement can be explored to determine if they are using high flow therapy.

[0030] According to one aspect of the present technology, a method for determining whether high flow therapy is being used by a patient is provided. The method includes: Evaluating the signals includes determining one or more signals from the one or more sensors and administering a respiratory therapy. Air is delivered from the therapeutic device along the air circuit to the unsealed patient interface. The characteristics of the airflow involved in the breathing rate per unit time were examined to determine whether they contained significant variations within the range of the breathing rate per unit time. and determining, based on the determining, that high flow therapy is administered to the patient. This includes generating an output indication within the controller as to whether the obtain.

[0031] In accordance with another aspect of the present technology, there is provided an apparatus for delivering high flow therapy to a patient, the apparatus comprising: The flow of air to the unsealed patient interface is directed along the air circuit at a prescribed therapeutic flow rate. The apparatus may include a servo-controlled blower configured to generate the amount of one or more transducers configured to generate respective signals of respective characteristics of the airflow passing through the The apparatus may include a central controller configured to control the servo-controlled blower. The apparatus may include a processor, the processor being adapted to receive one or more signals. The processor may be configured to determine a rate of airflow indicated by one of the one or more signals. Controlling whether the characteristic includes significant variation within a band of respiratory rate per unit time The processor may be configured to, in response to the determination, determine whether high flow therapy is to be used by the patient. The device may be configured to generate an indication of whether the sensor is in a locked state or not.

[0032] In accordance with another aspect of the present technology, there is provided an apparatus for delivering high flow therapy to a patient, the apparatus comprising: A flow control device that generates airflow along the air circuit to an unsealed patient interface. The apparatus may include a means for controlling the flow of the air. The device may include means for generating one or more signals indicative of respective characteristics of the airflow. The apparatus may include means for receiving a signal. The apparatus may include means for receiving a signal indicating availability as indicated by one of the one or more signals. Determine whether airflow characteristics contain significant variations in the frequency band of breathing per unit time In response to the determination, the device may include means for determining whether high flow therapy is being used by the patient. The measuring device may include means for generating an indication of the temperature.

[0033] In accordance with another aspect of the present technology, a high flow therapy system is provided. The system may include a non-sealed patient interface. The system may include an air circuit configured to be connected to a patient interface. It may include a servo-controlled blower configured to generate a flow of air along the air circuit. The system may include a central controller configured to control the servo-controlled blower. The system is configured to generate one or more signals indicative of respective characteristics of the airflow being generated. The system may include one or more transducers. The system may include a processor. The processor may be configured to receive one or more signals. The airflow characteristics represented by one of the signals are within the range of the number of breaths per unit time. The processor may be configured to control the determination as to whether the signal includes significant variation in the signal. responsive to the determination to generate an indication of whether high-flow therapy is being used by the patient. It can be configured.

[0034] Of course, some of the above aspects may form sub-aspects of the present technology. and / or various combinations of the various aspects may be used to provide further aspects of the present technology. Or it may constitute a subaspect.

[0035] Other features of the present technology are described in the following detailed description, drawings and claims. It becomes clear when you consider the following.

[0036] The present technology is illustrated by way of example and not by way of limitation in the accompanying drawings, in which like reference characters refer to: It contains the following similar elements: [Brief description of the drawings]

[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 nasal pillows and receives air at positive pressure from a RT device 4000. Air from the RT device is humidified in a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A sleep companion 1100 is also shown. [Diagram 2] [7.2 Respiratory System and Facial Anatomy] Figure 2 shows an overview of the human respiratory system, including the nose and oral cavity, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 3a]7.3 Patient Interface FIG. 3a shows a sealed patient interface 3000 suitable for respiratory pressure therapy. [Figure 3b] 3b shows a non-sealed patient interface 3800 that is suitable for high flow therapy and is used on the patient 1000. [Figure 4a] 7.4 Respiratory Therapy Device FIG. 4a shows a RT device 4000 in accordance with one form of the present technology. [Figure 4b] 4b is a schematic diagram of the pneumatic pathway of a RT device in accordance with one form of the present technology, with upstream and downstream directions shown. [Figure 4c] FIG. 4c is a schematic diagram of electrical components of an RT device in accordance with one form of the present technology. [Figure 5a] 7.5 Humidifier FIG. 5a shows an isometric view of a humidifier 5000. [Figure 5b] FIG. 5b is an isometric view of the humidifier showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 6a] 7.6 Therapy Usage Determination FIG. 6a is a schematic diagram of an electrical circuit that forms a simple model of an RT device that delivers high-flow therapy to a breathing patient through an unsealed patient interface. [Figure 6b] FIG. 6b is a schematic diagram of an electrical circuit that forms a more sophisticated model of an RT device that delivers high-flow therapy to a breathing patient. [Figure 6c] FIG. 6c is a schematic diagram of the electrical circuitry forming a two-nostril model of an RT device for delivering high-flow therapy to a breathing patient. [Figure 7a] FIG. 7a is a flow chart illustrating a method for determining if a patient is using high-flow therapy in accordance with one form of the present technology. [Figure 7b] FIG. 7b is a flowchart illustrating a method of monitoring high flow therapy for a patient in accordance with one form of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0038] Before describing the present technology in more detail, it is important to understand that the present technology is It should be understood that the present invention is not limited to the specific examples that may be used. The terms used herein are for the purpose of describing the specific examples described herein and are not limiting. It should also be understood that this is not a one-size-fits-all solution.

[0039] The following description relates to various examples that may share one or more common characteristics and / or features. One or more features of any one example may be used interchangeably with one or more of another example or with one or more of the other examples. It should be understood that the features can be combined. Any single feature or combination of features in any of the above may constitute further examples. It can be achieved.

[0040] 8.1 Therapy In one embodiment, the present technology provides a high flow rate of air adjacent to the entrance of the patient's 1000 airways. The present invention includes a method for treating a respiratory disorder comprising the step of delivering

[0041] In a particular example of the present technology, the airflow is directed through one or both of the patient's nasal passages. High flow rates are delivered to the tract.

[0042] 8.2 Treatment Systems In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. Or the device may deliver air to the patient 1000 at a high flow rate through an unsealed patient interface. The RT device 4000 may be delivered to the base 3800 via an air circuit 4170.

[0043] 8.3 Patient Interface The non-invasive sealed patient interface 3000 according to one aspect of the present technology comprises: Functional aspects include: a sealing forming structure 3100, a cavity chamber 3200, a positioning and stabilizing structure 3 300, a vent 3400, a connection port 3600 for connection to an air circuit 4170 In use, the seal forming structure 3100 is configured to It is positioned to surround an entrance to the patient's airways so as to facilitate the supply of air to the airways.

[0044] The non-sealed patient interface 3800 takes the form of a nasal cannula and a nasal prong. The nasal protrusions 3810a and 3810b are adapted to ingest air. Such nasal protrusions may be located inside or outside the nostrils of the subject 1000. Air to the nasal protrusions is often not able to form a seal with the skin on the side of the nose. One or more air supply loops connected to the interface 3800 in the form of a nasal cannula The fluid may be delivered through lumens 3820a and 3820b. 20b extends from an unsealed patient interface 3800 in the form of a nasal cannula. , extending to a RT device that generates air flow at a high flow rate.

[0045] Another example of a non-sealed patient interface 3800 is a transtracheal interface. There is a base.

[0046] 8.4 Respiratory Therapy Devices The RT device 4000 according to one aspect of the present technology includes mechanical and pneumatic components 4100. 4200 and configured to execute one or more algorithms 4300. The RT device may have an outer housing 4010. is formed in two parts, an upper part 4012 and a lower part 4014. The outer housing 4010 may include one or more panel(s) 4015 . The RT device 4000 may include a system that supports one or more internal components of the RT device 4000. The RT device 4000 may include a chassis 4016. The RT device 4000 may include a handle 4018.

[0047] The air pressure path of the RT device 4000 may include one or more air path items (e.g., an inlet air Air filter 4112), inlet muffler 4122, pressure generator capable of delivering air at high flow rates A compressor 4140 (e.g., a blower 4142), an outlet muffler 4124 and one or more transpiration units. 4270 (e.g., pressure sensor 4272 and flow sensor 4274) It may include.

[0048] One or more of the air path items is a moveable integral structure called a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016. or formed as part of the chassis 4016.

[0049] The RT device 4000 includes a power source 4210, one or more input devices 4220, a central control a therapy device controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, memory 4260, transducer 4270, data communication interface 4 280 and one or more output devices 4290. Alternatively, the PCBA 4202 may be mounted on a single printed circuit board assembly (PCBA). In addition, the RT device 4000 may include more than one PCBA 4202.

[0050] 8.4.1 RT Device Mechanical & Pneumatic Components An RT device may include one or more of the following components as an integral unit: In the embodiment, one or more of the following components may be arranged as separate units: .

[0051] 8.4.1.1 Air filter(s) An RT device in accordance with one form of the present technology includes an air filter 4110 or multiple air filters. It may include data 4110.

[0052] In one form, the inlet air filter 4112 is configured to filter the air upstream of the pressure generator 4140. It is located at the beginning of the pressure pathway.

[0053] In one form, an outlet air filter 4114, such as an antibacterial filter, is provided in the air pressure block. It is disposed between the outlet of 4020 and the patient interface.

[0054] 8.4.1.2 Muffler(s) In one form of the present technology, an inlet muffler 4122 is upstream of a pressure generator 4140. It is disposed in the air pressure path.

[0055] In one form of the present technology, the outlet muffler 4124 is connected to a pressure generator 4140 and a patient interface. The pressure sensor is disposed in the air pressure path between the surface of the bearing and the bearing face.

[0056] 8.4.1.3 Pressure generator In one form of the present technology, a pressure generator 4140 that generates a high flow rate of air is For example, the blower 4142 may be a brushless DC motor 414 4 with one or more impellers housed in a volute. The air flow may be servo-controlled to deliver a therapeutic flow rate Qth. In this case, the total airflow Qt is calculated by the flow transducer and the blower 414 as follows: This allows the total flow rate, Qt, to be adjusted to or close to the therapeutic flow rate, Qth. The pressure Pd of the airflow at the output of blower 4142 is adjusted to maintain The therapeutic flow rate, Qth, may be as high as about 120 liters per minute, but is more typically between 20 and 30 liters per minute. 0 liters / minute.

[0057] The blower 4142 may be described in any one of the following patents or patent applications: The following documents are incorporated by reference in their entirety: U.S. Pat. No. 7,866,944; U.S. Pat. No. 8,638,014, U.S. Pat. No. 8,636,479; and PCT published patent applications. No. WO2013 / 020167.

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

[0059] In other embodiments, the pressure generator 4140 may be a piston-driven pump, a high pressure source (e.g., The pressure regulator may be connected to a compressed air reservoir, or a bellows.

[0060] 8.4.1.4 Transducer(s) The transducer 4270 may be internal to the RT device or may be The external transducer may be located on the air circuit or , or may form part of it (e.g., the patient interface). The transducer may take the form of a non-contact sensor (e.g., transmitting data to a device or Doppler radar movement sensor with forwarding).

[0061] In one form of the present technology, one or more transducers 4270 are connected to a pressure generator 414 0. The one or more transducers 4270 are particularly characteristics (e.g. flow rate, pressure, absolute or relative humidity or temperature at a point in the air path) The transducer 4270 may be constructed and arranged to measure these It generates signals indicative of the characteristics and transmits these signals to the central controller 4230.

[0062] In one form of the present technology, one or more transducers 4270 are In another form of the present technology, one or more transducers 4 The external transducer 270 may be located near the air outlet of the RT device 4000. Measure the atmospheric conditions (e.g., atmospheric pressure, temperature, or relative or absolute humidity) It may also be used for

[0063] In one form, the signal from the transducer 4270 is filtered (e.g., low-pass, high-pass, The signal may be filtered (by pass or band pass filtering).

[0064] 8.4.1.4.1 Flow Transducers The flow transducer 4274 according to the present technology is a differential pressure transducer (e.g., SE The differential pressure transducer may be based on the SDP600 series from NSIRION.

[0065] In one embodiment, the flow transducer 4274 is delivered from the RT device 4000. The system generates a signal indicative of the total airflow Qt being received.

[0066] 8.4.1.4.2 Pressure transducers A pressure transducer 4272 according to the present technology is placed in fluid communication with the pneumatic path. An example of a suitable pressure transducer is the HONEYWELL ASDX series. Another suitable pressure transducer is the GENERAL ELE There are sensors from the NPA series from CTRIC.

[0067] In one embodiment, the pressure transducer 4272 is at the outlet of the RT device 4000. The pressure sensor 100 generates a signal indicative of the pressure Pd of the airflow passing through the pressure sensor 100.

[0068] 8.4.1.4.3 Motor Speed ​​Transducers In one form of the present technology, a motor speed transducer 4276 is and / or may be used to determine the rotational speed of the blower 4142. The motor speed signal from the motor speed sensor 4276 can be provided to the therapy device controller 4240. The Data Speed ​​Transducer 4276 is a speed sensor, e.g. a Hall effect sensor. could be.

[0069] 8.4.1.4.4 Other transducers One or more humidity / temperature sensors, such as the Sensirion SHT75, are used to measure the temperature of the treatment air flow. The temperature and humidity of the liquid may be determined by the temperature sensor.

[0070] One or more electrical sensors may be connected to the motor 4144 or the humidifier 5000 or its respective power unit. The device may be configured to sense a current consumed by the unit. The sensed current may be used to Used to determine the instantaneous or average power consumed by a system or its components. It is possible.

[0071] 8.4.1.5 Spill-back prevention valves In one embodiment of the present technology, the spillback prevention valve is connected to the humidifier 5000 and the pneumatic block 4 The spill-back prevention valve is disposed between the humidifier 5000 and the humidifier 5000. The motor 4144 may be constructed and arranged to reduce the risk of electrical leakage to the motor 4144.

[0072] 8.4.1.6 Air circuits An air circuit 4170 according to aspects of the present technology includes two components (e.g., a pneumatic block 4 020 and patient interface) during use. The pipe or conduit is constructed and laid.

[0073] In particular, the air circuit 4170 is connected to the outlet of the pneumatic block and to the patient interface. This air circuit may be referred to as an air delivery tube. There may be separate lobes of the circuit for inhalation and exhalation. In other cases a single lobe is used. can be done.

[0074] In some forms, the air circuit 4170 heats the air in the air circuit (e.g., , to maintain or increase the air temperature. The heating element may take the form of a heated wire circuit and may include one or more transducers (e.g., In one form, the heated wire circuit may include an axial The heating element may be spirally wound around a circumference of the heating element. An example of an air circuit 4170 that includes a heated wire circuit is shown in FIG. No. US / 2011 / 0023874. This document is incorporated by reference in its entirety.

[0075] 8.4.1.7 Oxygen Delivery In one form of the present technology, additional oxygen 4180 is added at 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 The data is delivered to the interface.

[0076] 8.4.2 RT Device Electrical Components 8.4.2.1 Power supply The power supply 4210 may be internal or external to the external housing 4010 of the RT device 4000. It can be arranged.

[0077] In one form of the present technology, the power supply 4210 provides power only to the RT device 4000. In another form of the present technology, the power supply 4210 may be connected to the RT device 4000 and the humidifier 5. 000Provides power to both.

[0078] 8.4.2.2 Input Devices In one embodiment of the present technology, the RT device 4000 enables interaction between humans and devices. one or more input devices 42 in the form of buttons, switches, or dials for 20. A button, switch or dial may be a physical device or Alternatively, it may be a software device accessible via a touch screen. The buttons, switches or dials, in one form, are physically attached to the outer housing 4010. The devices may be electrically connected to the central controller 4230 or may be electrically connected to the central controller 4230 in another form. The wireless communication may be performed with a receiver.

[0079] In one form, the input device 4220 allows a person to input values ​​and / or menu options. The present invention may be constructed and arranged to allow selection of

[0080] 8.4.2.3 Central Controller In one form of the present technology, a central controller 4230 is adapted to control the RT device 4000. One or more processors.

[0081] A suitable processor is the ARM Cortex-M3 processor from ARM Holdings. ex®-M processors (e.g., from ST MICROELECTRONIC) Intel's STM32 series microcontroller-based x86 processor In another particular embodiment of the present technology, the processor may include a 32-bit RISC CPU. (For example, the STR9 series microcontrollers from ST Microelectronics. M, a microcontroller manufactured by Texas Instruments 16-bit RISC CPUs, such as processors from the SP430 family, are also suitable. It is possible.

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

[0083] In one form, the central controller 4230 is an application specific integrated circuit. In this case, the central controller 4230 is a discrete electronic component.

[0084] The central controller 4230 controls one or more transducers 4270 and one or more input devices. The input signal(s) may be configured to receive an input signal(s) from a device 4220.

[0085] The central controller 4230 controls the output device 4290, the therapy device controller 4240, the data The output signal ( The present invention may be configured to provide a single or multiple

[0086] In some forms of the present technology, the central controller 4230 may include one or more of the components described herein. The above method (e.g., a non-transitory computer-readable storage medium (e.g., memory 4 260) one or more algorithms expressed as computer programs stored in In some forms of the present technology, a central control The controller 4230 may be integrated with the RT device 4000. However, some of the techniques In some embodiments, the method may be performed by a remotely located device. For example, The remotely located device may then read the stored data (e.g., the sensors described herein). (from either Respiratory related episodes may be detected.

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

[0088] 8.4.2.5 Therapy Device Controller In one form of the present technology, the therapy device controller 4240 is 4300. The control module 4330 forms part of the algorithm 4300 executed by the processor 4300.

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

[0090] 8.4.2.6 Protection circuit The one or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure protection circuits. A safety circuit may be included.

[0091] 8.4.2.7 Memory According to one aspect of the present technology, the RT device 4000 includes a memory 4260 (e.g., a non-volatile In some embodiments, the memory 4260 includes battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

[0092] The memory 4260 may be located on the PCBA 4202. The memory 4260 may include an EEPROM. It can take the form of OM or NAND flash.

[0093] Additionally or alternatively, the RT device 4000 may include a removable form of memory 42. 60 (e.g., notes created based on the Secure Digital (SD) standard) Ricardo).

[0094] In one form of the present technology, the memory 4260 may be configured to implement one or more of the methods (e.g. For example, a stored computer program representing one or more algorithms 4300. It functions as a non-transitory computer-readable storage medium having instructions stored thereon.

[0095] 8.4.2.8 Data communication systems In one form of the present technology, a data communication interface 4280 is provided, The data communication interface 4280 is connected to a remote external communication network. network 4282 and / or a local external communications network 4284. The remote external communications network 4282 can be connected to a remote external device 4286. The local external communication network 4284 may be connected to a local external device 4288. It may be possible to continue.

[0096] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is The device may be separate from the processor and may include an integrated circuit or a processor.

[0097] In one embodiment, the remote external communications network 4282 is the Internet. The communication interface 4280 is a Wired communications (via the Internet or optical fiber) may be used, or wireless communications may be used. Any protocol (eg, CDMA, GSM, LTE) may be used.

[0098] In one embodiment, the local external communication network 4284 is compliant with one or more communication standards (e.g. For example, Bluetooth or consumer infrared protocols, or power line communication. (Faith) is used.

[0099] In one embodiment, the remote external device 4286 is one or more computers (e.g., In one embodiment, the remote external device 428 6 may be a virtual computer rather than a physical computer. In either case, Such remote external devices 4286 are accessible only to appropriately authorized personnel, such as clinicians. It may be possible.

[0100] The local external device 4288 can be a personal computer, a mobile phone, a tablet, or or a remote control.

[0101] 8.4.2.9 Output Devices The output device 4290 according to the present technology may be one or more of a visual, audio, and tactile unit. The visual display may take the form of a liquid crystal display (LCD) or a light emitting diode. The display may be a LED (light emitting diode) display.

[0102] 8.4.2.9.1 Display Drivers The display driver 4292 outputs characters, It receives signals or images as input and converts them into commands. As a result, the display 4294 displays these letters, symbols or images.

[0103] 8.4.2.9.2 Display The display 4294 responds to commands received from the display driver 4292. In response to a command, the display is configured to visually display characters, symbols, or images. The ray 4294 may be an eight-segment display, in which case the display driver 4 292 converts each character or symbol (e.g., the number "0") into a character that represents a specific character or symbol. The 8 segments are then converted into 8 logic signals that indicate how each of the 8 segments should be activated. .

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

[0105] 8.4.3 RT Device Algorithms 8.4.3.1 Determining the Use of High-Flow Therapy The present invention is an improvement in the field of respiratory therapy (specifically, using a respiratory therapy device). For example, the present technology provides a non-sealed patient interface. Automatically determine conditions associated with the use of high-flow therapy for patients when a high-flow device is used Such determination or determinations may be made by a processor. In other words, the improvement (single or multiple) in the functionality of the controller or processor can be achieved. For example, in one form of the present technology, an algorithm is provided to determine the use of high-flow therapy. The rhythm is a signal indicating the pressure Pd at the RT device outlet and a signal indicating the pressure Pd at the RT device outlet. The device receives as input a signal indicative of the total flow rate, Qt, of air being delivered. The algorithm for determining whether high-flow therapy is being used by the patient 1000 is The method produces as output a time series of rule usage indications at successive times.

[0106] In one form of the present technology, a central controller 4230 of the RT device 4000 controls high flow therapy. The system may then execute an algorithm to determine how to use

[0107] In another form of the present technology, the algorithm that determines the use of high flow therapy is A remote control configured to communicate with the RT device 4000 via a communication network 4282. The method may be executed by a processor of the remote computing device 4286. In this configuration, the RT device 4000 exhibits a device pressure Pd and a total flow rate Qt. The signal is transmitted to a remote external computing device via a remote external communications network 4282. The remote external computing device 4286 may then transmit Implement an algorithm to determine dosage regimen usage.

[0108] In yet another embodiment, the algorithm for determining the use of high-flow therapy is The system 4000 may be implemented in part by a central controller 4230, and in part by a remote external computer. The processing may be executed by a processor of the processing device 4286. For example, the processing may be executed by a processor of the central controller 4230. may process the device pressure and total flow signals to generate intermediate outputs, and these intermediate outputs may be to a processor in a remote external computing device 4286, and then an intermediate output are processed to generate time-series usage indications.

[0109] In either case, the algorithms that determine the use of high-flow therapy are in “real time.” It may be performed post-processing (i.e., after the therapy session is completed) or (for stored data indicating device pressure Pd and total flow Qt). For a processing run, device pressure and flow data are predefined as time series samples. on the memory 4260 of the RT device 4000 and / or remotely at the selected sampling rate. It may be stored on the memory of the external computing device 4286.

[0110] The device pressure and total flow signals are obtained from a suitably positioned pressure transducer 427. 2 and flow transducer 4274, respectively. In this study, the algorithm that determines the use of high-flow therapy is based on the pressure in the patient interface. A signal indicative of the patient interface pressure Pm is received as an input. The pressure may be generated directly by a pressure transducer 4272 or by input It is formed from the device pressure Pd by a pressure compensation algorithm that also takes the total flow rate Qt as a force. The pressure compensation algorithm calculates the pressure drop through the air circuit 4170 using the total flow Qt. The patient interface pressure is calculated by subtracting the estimated pressure drop from the device pressure Pd. Calculate the pressure Pm.

[0111] The RT Device 4000 uses an algorithm to determine how high-flow therapy is used. The collected usage readings may be accumulated into a historical record of the patient's 1000 high flow therapy usage. The TDevice 4000 may take different actions based on such usage records. One example of such an action is administering high flow therapy to the patient 1000 for a given interval. Such reports may be used to via a remote communications network 4282, e.g., associated with a healthcare provider It may be transferred to a remote external computing device 4286.

[0112] In another example, the therapy control module 4330 of the RT device 4000 may control high flow therapy. In response to the record of usage, one or more parameters of the high-flow therapy (e.g., therapeutic flow rate Qt h) can be adjusted, for example if usage records indicate a decline in usage over time. In this case, the therapeutic flow rate Qth can be reduced to encourage the use of high-flow therapy. In some cases, the usage indications or accumulated records are evaluated in the controller to determine the It can serve as a trigger for changing the operation of the controller of the T device 4000. An example of such a condition would be when sufficient usage indications are met (e.g., a particular time threshold is met). If the usage indication indicates that the device is not being used at all, the controller Treatment may be discontinued (e.g., by changing the control operation of the blower motor, (reduce or stop flow generation).

[0113] The RT device 4000 may generate output data based on usage indications or a stored record of such indications. For example, if the accumulated records indicate that patient 1000 If the user indicates that the use of high-flow therapy has been discontinued for more than a predetermined interval, the RT device 400 0 may generate a warning. Such a warning may be, for example, the output of the RT device 4000. (e.g., a sound generator or speaker of the RT device 4000 or the RT device 4 Activation of other sound generators or speakers on a device that communicates with the 000 or RT device 4000 displays 4294 outputs Activates a warning light or communicates with the RT Device 4000 Local or remote external device receiving 4288 or 4286 other display activity sexualization).

[0114] FIG. 6a is a circuit diagram of an electric circuit model 6000. The electric circuit model 6000 is a high current A non-sealed patient interface (e.g., The RT device 40 is delivered through an unsealed patient interface 3800. This is a simple model of the 6000. In the electric circuit model 6000, voltage models pressure, The current models the flow rate. The RT device 4000 is driven by a controlled voltage source 6010. The air circuit 4170 is modeled by a resistor 6030. Qt is modeled by the current in the air circuit resistance 6030, and the device pressure Pd is modeled by the current The pressure source 6010 is modeled by the voltage at the output of the pressure source 6010. The pressure Pm in the interface 3800 is determined by the voltage at the end of the air circuit resistor 6030. If the air circuit 4170 is blocked, the air circuit resistance 6030 is infinite. (i.e., open circuit). The resistance between the inside of the subject's nose and the interface resistance 6050 is modeled. The pressure in the patient's nose, Pnose, is determined by the voltage at the ends of the interface resistor 6050. This is modeled as follows.

[0115] The respiratory system of the patient 1000 is connected to an airway resistance in series with a capacitance 6035 and an AC voltage source 6020. The capacitance 6035 is modeled by the air pressure compliance of the patient's lungs. The AC voltage source 6020 models the small negative voltage during the inspiration portion of the breathing cycle. By alternating between a positive voltage and a small positive voltage during the expiratory portion of the breathing cycle. , to model the breathing of a patient 1000.

[0116] 6b is a circuit diagram of the electric circuit model 6100. The electric circuit model 6100 is shown in FIG. A non-sealed patient interface 3800 instead of the electrical circuit model 6000 The RT device 4000 delivers high flow therapy to a breathing patient 1000 via a This is an advanced model. The electric circuit model 6100 includes elements 6110, 6120, 6125, 6130, 6135, and 6150. These elements are included in the Electrical Circuit Model 6000 and its respective counterparts 6010, 6020, 6025, 6030, 6035 and 6050 therein. The circuit model 6100 is in parallel with the model 6025 / 6010 of the patient 1000. It also includes a further "leakage resistor" 6140 for grounding. The leakage resistor 6140 is hermetically sealed. The patient interface 3800 is not sealed, and the patient interface 380 is not sealed. 1000 , which interfaces with the airway (single or multiple) of the patient 1000 Models leakage paths from inside the patient's nose to the atmosphere due to gaps between the Since the leakage resistance 6140 is lower than the patient airway resistance 6125, the total flow Qt is This is significantly different from the patient respiratory flow Qr, which is modeled as a current in resistor 6125. The interface is properly positioned on the patient's face, not the leakage resistor 6140. A much higher impedance model was used to model the air flow through vent 3400 to the atmosphere at The device used was a more conventional sealed or pressurized device used to deliver respiratory pressure therapy. In such a system, the impedance to the atmosphere is If the patient is using respiratory pressure therapy and the interface is There is a large difference in static pressure in the system between when the switch is turned on and when it is turned off. Therefore, a straightforward method to detect when a patient is using respiratory pressure therapy from static pressure is required. It's direct.

[0117] The leak resistance 6140 is connected to the airway entrance (single) of the unsealed patient interface 3800. It depends on the position of the object relative to the object (the number or numbers of objects), which cannot be predicted with a high degree of accuracy. Therefore, the leakage resistance 6140 is modeled as a variable. When the interface 3800 is disconnected from the patient's airway entrance, the leakage resistance is extremely low ( i.e., close to a short circuit).

[0118] In one implementation, a controlled voltage source 6110 is servo-controlled to generate an AC voltage. The output voltage of the pressure source 6120 varies over the respiratory cycle (modeling patient breathing). Maintain total flow Qt at or around the therapeutic flow Qth during treatment. In this embodiment, the device pressure Pd is in phase with the output of the AC voltage source 6120 and is a single The DC pressure varies around the constant pressure (DC) in terms of the number of breaths per hour (i.e., The total flow Qt decreases during the inhalation portion and increases during the exhalation portion, and the total flow Qt increases throughout the respiratory cycle. (The therapeutic flow rate Qth remains constant over time.) This implementation is performed using a controlled voltage source 61 It can be modeled by replacing 10 with a constant current source that supplies a current Qth. In another implementation of the servo control, the device pressure Pd remains constant throughout the respiratory cycle. The total flow rate Qt is calculated by the AC voltage source at the number of breaths per unit time for 1000 patients. The AC voltage Vth varies around the therapeutic flow rate Qth in anti-phase with the output of the 6120. is negative) and is higher than the therapeutic flow Qth in the inspiratory portion (when the AC voltage is positive (In the expiratory portion, the therapeutic flow rate Qth is lower than that of the expiratory portion). For a patient with 1000 respiratory rates per unit time, the total flow Qt is the therapeutic flow Qth fluctuates slightly in opposite phase to the output of the AC voltage source 6120 around slightly higher than the therapeutic flow rate Qth in the exhalation portion and slightly lower than the therapeutic flow rate Qth in the exhalation portion. On the other hand, the device pressure Pd is equal to the output of the AC voltage source 6120 around the steady pressure. Varies slightly with phase (i.e., slightly lower during inspiration and slightly higher during expiration) In reality, regardless of the implementation, the transducer 427 used in the servo control implementation Since 0 is incomplete, both the device pressure Pd and the total flow rate Qt are This results in a small but non-zero variation in the respiratory rate of the patient. This determines whether the main fluctuation is the device pressure Pd, the main fluctuation is the total flow rate Qt, or both. It is determined which signal fluctuates.

[0119] One objective of the disclosed algorithm for determining how to use high-flow therapy is to The number of breaths per unit time generated by 1000 patients using the device is within the band These variations in pressure Pd and / or total flow Qt may be detected. It is advantageous to make the implementation of the servo control substantially independent, since this implementation is carried out in accordance with the present invention. This is because the indicated high flow rate is not necessarily known to the algorithm that determines how to use it. Such fluctuations may occur if the patient 1000 is not using high flow therapy (e.g., an air circuit 4170 is blocked or disconnected from the patient's airway inlet. do not have.

[0120] FIG. 7a is a block diagram of a system for implementing an algorithm for determining how to use high-flow therapy in accordance with one form of the present technology. 7 is a flowchart illustrating a method 7000 that may be used to However, if an appropriate threshold is set, the method The method 7000 functions effectively using the patient interface pressure Pm.

[0121] The method 7000 begins at step 7010. Step 7010 determines whether the total flow rate Qt is Determine if a flow threshold is exceeded. In one implementation, the flow threshold is 10 liters / min. Step 7010 checks whether the RT device 4000 is delivering airflow at a high rate. Reasons why a high flow rate may not be delivered include pressure generator 41 40 is not working or is broken, or the air circuit 4170 or There is a condition in which the unsupported patient interface 3800 is obstructed or occluded. If the quantity Qt does not exceed the flow rate threshold (“N”), the method 7000 proceeds to step 7070. Step 7070 returns a value of "false" to indicate that the patient 1000 is not using high-flow therapy. This indicates that

[0122] If the total flow Qt exceeds the flow threshold ("Y"), the method 7000 proceeds to step 7020. In step 7020, both the total flow Qt and the device pressure Pd are expressed in human units. A range of respiratory rate fluctuations or frequencies (unit time) covering the limits of the number of respiratory rates per hour Step 7020 is bandpass filtered up to a band of the number of breaths per minute. Short-term variations in pressure and flow (i.e., breathing rates exceeding typical breathing rates per unit time) The purpose of this method is to eliminate the component of the frequency of the absorption (variation in frequency or number of absorptions). The components are not intended to be relevant to determining whether high flow therapy is being used by the patient 1000. In one implementation, the upper cutoff of the bandpass filter The breathing rate or frequency is 0.05, which is the upper limit of the number of breaths per unit time for a human at rest. Step 7020 calculates the long-term variation ( i.e., fluctuations in rate or frequency below the typical respiratory rate per unit time) In one implementation, the bandpass filter The lower cutoff frequency or frequency is approximately the lower of the respiratory rate per unit time of a human at rest. The bandpass filtering in step 7020 is The average or steady-state values ​​of the filtered total flow Qt' and device pressure Pd' are It is configured to be invariant to the respective values ​​of the total flow rate Qt and the device pressure Pd.

[0123] Fixed upper and lower cutoff times or frequencies As an alternative example of use, in the bandpass filtering step 7020, The number of breaths per hour can first be estimated. This can be done, for example, by using the total flow Qt, the device pressure For example, in the Fourier transform of the ratio of the force Pd, or the total flow rate Qt, to the device pressure Pd, The location of the highest peak (e.g., as determined by a fast Fourier transform algorithm) This ratio can be calculated by searching for the number of The highest peak position is useful because it has a significant component in the respiratory rate of the patient. Then, a bandpass filtering step is performed. The upper cutoff frequency or frequency and the lower cutoff frequency or frequency of the 7020 are: It can be derived from an estimate of the number of breaths per unit time. For example, the lower cutoff rate or The frequency can be half the estimated number of breaths per unit time, and is the upper cutoff number or the circumferential number. The wave rate can be twice the estimated number of breaths per unit time.

[0124] A fixed upper cutoff time or frequency and a lower cutoff time in step 7020 As a further alternative to using off times or frequency, patient height can be used to Example of determining upper and lower cutoff times or frequencies Because the patient height is proportional to the unit time of a resting person, due to well-known physiological relationships, The patient height is input via the input device 4220 as a function of the number of breaths per minute. This can be entered as a setting on the T device 4000.

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

[0126] In the next step 7030, the bandpass filtered device pressure Pd' by the bandpass filtered total flow Qt' to obtain the air circuit The resistance to flow in the 4170 is calculated. The resistance to flow is calculated using two bandpass filters. The resistance to flow is also calculated from the bandpass filtered signal. Although not obtained directly from the sampling, the bandpass filtered signal It can be regarded as such.

[0127] Next, step 7035 determines whether resistance to flow is greater than 100% for the patient 100 using high flow therapy. Determine whether a characteristic of 0 is within a predetermined range. In one implementation, the predetermined range is: 0.4cmH2O / liter / minute to 0.9cmH2O / liter / minute. Step 7 If 035 determines that the resistance to flow is not within a predetermined range ("N"), then method 7 000 proceeds to step 7070 and returns a value of "false." The resistance to flow is determined by the RT data. The device pressure Pd is substantially independent of the servo control applied from the device 4000. As described above, in one execution of servo control, the entire range of respiratory rate is The variation is that of the device pressure Pd. In another implementation of servo control, the band of respiratory rate The total variation in the area is that of the total flow Qt. In the row, as long as patient 1000 is using high flow therapy, the total flow rate of the device pressure Pd The ratio of Qt (resistance to flow) falls within a certain range. However, this is not the case at high flow rates. Since this is not a sufficient condition for determining that a dose regimen is being used, step 703 If method 700 determines that the resistance to flow is not within a predetermined range ("Y"), 0 proceed to step 7040.

[0128] Steps 7040 and 7045 are performed to determine whether the characteristics of the delivered air flow are consistent with those of step 7020. The number of breaths per unit time for humans defined by the cutoff number or frequency of The objective is to determine whether the band contains significant variations. is the bandpass filtered signal over a sliding window of given duration In one implementation, step 7040 calculates the magnitude of variation of one of the The standard deviation over a sliding window of 1 minute duration of the end-pass filtered signal Calculate the standard deviation of the sensitivity to the mean over this window. Since the time is not required, it is possible to use it and thus encompasses the entire variation within the window. Other implementations of P7040 include: Average subtracted bandpass filtered over a sliding window Calculating the magnitude of the fluctuations using the number of zero crossings of the signal; - Bands of respiratory rates calculated over a sliding window Calculate the power of the Fourier transform spectrum of the (unfiltered) signal at To do so; The number of breaths per unit time calculated over a window of given duration Fourier transform spectrum of the (unfiltered) signal at harmonics in the band The power of the patient 1000 is then calculated, and thus the harmonics (which may indicate, for example, the presence of snoring) are also Indicates absorption.

[0129] Steps suitable for implementation where the device pressure Pd remains constant throughout the respiratory cycle In one implementation of the 7040, the bandpass filtered signal is The total flow Qt is constant throughout the entire respiratory cycle. In another run of step 7045 that is appropriate for the ongoing run, the bandpass filter line The signal sampled is the bandpass filtered device pressure Pd'. In yet another execution of step 7045, suitable for an intermediate execution of the control, a band pass filter The ringed signal is the resistance to flow calculated in step 7030 .

[0130] Then, step 7045 determines whether the magnitude of the fluctuation of the bandpass filtered signal is Determine whether the bandpass filtered signal exceeds the magnitude threshold. In one run, the filtered total flow rate Qt' was set at a size threshold of 10 liters. Step 7045 determines whether the fluctuation magnitude of the bandpass filtered signal is large. If it is determined that the size threshold ("N") is not exceeded, the method 7000 proceeds to step 7070. and returns a value of "false".

[0131] If not ("Y" at step 7045), method 7000 proceeds. , the bandpass filter as the sliding window over which the magnitude is calculated slides forward. The filtered signal itself (e.g., the bandpass filtered total flow Qt') Determine whether the magnitude of change in respiratory demand varies significantly. Respiratory demand typically changes slowly over time. To achieve this, we use the bandpass filtered signal with the following variation in amplitude: The presence of tends to identify high flow therapy being used by the patient 1000. Therefore, step 7050 continues to iterate over a further sliding window of a given duration. Calculate the magnitude of the fluctuation of the pass-pass filtered signal. Then, a further sliding window is applied to measure the fluctuation magnitude of the bandpass filtered signal. may be of the same duration as the sliding window calculated in step 7040. Then, step 7055 calculates the variation of the variation magnitude of the bandpass filtered signal. It determines whether the degree exceeds a magnitude change threshold. The magnitude change threshold determines whether further sliding The longer the sliding window, the smaller the A threshold value for the magnitude variation should be selected. In one run, the total double-pass filtered flow rate Qt' is The windows are 1 minute in duration, have a wide range of magnitude fluctuations, and show large flow rates. The variation threshold is 0.002.

[0132] Step 7055 determines the degree of fluctuation in the fluctuation magnitude of the bandpass filtered signal. If it is determined that the magnitude change threshold ("N") is not exceeded, the method 7000 proceeds to step 7070. and returns a value of "false" indicating that high-flow therapy is not being used by patient 1000. If not ("Y"), the method 7000 proceeds to step 7060 to It returns a value of “true” indicating that the therapy is being used by the patient 1000 .

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

[0134] In another implementation of the algorithm for determining use of high flow therapy, steps 7040 and and 7045 (and optionally 7050 and 7055) are Instead, the device pressure Pd or resistance to flow calculated in step 7030 is used. In such an implementation, step 7045 (and any In this case, different thresholds are applied in

[0135] 8.4.3.2 High-Flow Therapy Monitoring In one form of the present technology, the high flow therapy monitoring algorithm comprises: A signal showing the pressure Pd being applied to the RT device 4000 and a signal showing the total flow rate Qt of air being delivered from the RT device 4000 are shown. The high-flow therapy monitoring algorithm receives as input a signal at successive times It produces as output a time series of indications of the status of high-flow therapy. The status indication in can take one of several values. These values ​​are Each indicates a different state of high-flow therapy (e.g., "in use," "not in use," "device "Air Circuit Blocked" and "Air Circuit Disconnected"). The degree or degrees may be stored in memory 426 or determine an indicator. On the user interface or display of the controller 4230 of the RT device 4000 A controller 4000 of the RT device 4000 may output or determine indicators to the display of 230 for display on a user interface or display. obtain.

[0136] As discussed above in relation to the algorithm for determining whether to use high-flow therapy, The monitoring algorithm may be implemented by a central controller 4230 in the RT device 4000, a remote external computer, or the like. The processor of the 4286 operating device, or "real-time" or post-processing Certain combinations of these two processes can be implemented. As discussed above in relation to the algorithm that determines how to use high-flow therapy, The rhythm may accumulate status indications as a chronological record of high-flow therapy status. 00 may take different actions based on the recording of such conditions. For example, In some cases, the status indication or an accumulated record of status indications is evaluated in the controller to It may act as a trigger for changing the operation of the controller 4230 of the RT device 4000. For example, a sufficient number (e.g., a series) of status indications may indicate non-use, obstruction, and / or If a disconnection is indicated, the controller 4230 may, for example, change the control action of the blower motor 4144. By doing so, treatment may be interrupted (e.g., by reducing flow production or Optionally, for example, a sufficient number (e.g., a series) of status indications may indicate an occlusion. If so, the controller 4230 may increase therapy (e.g., by reducing the control of the blower motor, for example). (Increasing flow generation by modifying the control operation).

[0137] FIG. 7b is a schematic diagram of a system for implementing a high-flow therapy monitoring algorithm in accordance with one form of the present technology. The method 7100 is described below in detail with respect to the device. However, if an appropriate threshold is set, the method 7100 can , it can function effectively using the patient interface pressure Pm.

[0138] The steps in method 7100 and the steps in method 7000 are numbered relative to each other. The steps (e.g., 7130 and 7030) are referenced relative to the steps in method 7000. In general terms similar to the numbered steps, method 7100 includes the following: Similar to method 7000 except.

[0139] The first step 7110 determines whether the device pressure Pd is below a threshold. If the pressure Pd falls below the threshold, the pressure generator 4140 is not working or has failed. If so ("Y"), method 7100 proceeds to step 7115, Concluding the method 7100 and returning an indication value of "device not operational." If not ("N"), method 7100 continues with steps 7120 and 7130. Steps 7120 and 7130 are the same as steps 7020 and 7030 described above. Same as 030.

[0140] After step 7130, step 7133 determines whether the resistance to flow is too small (i.e. This is equivalent to 0.4 cmH2O / liters / minute in one run, step 7035. If so ("Y"), check whether the The method 7100 proceeds to step 7137 to conclude the method 7100 and determine whether the indicator Returns a "disconnected" indication value. This value is not sealed. indicates that the patient interface 3800 is disconnected from the airway of the patient 1000. , thereby reducing the leakage resistance 6140 in the circuit model 6100.

[0141] If not ("N" at step 7133), method 7100 continues at step 71 38 and found that there was too much resistance to flow (i.e., 0.9 cm Above the upper end of the range used in step 7035, which is equal to 10000 H2O / liters / minute If so ("Y"), method 7100 proceeds to step 7139. The method 7100 concludes by determining whether the indicator is blocked. This value indicates that the air circuit 4170 may be blocked. If not ("N"), method 7100 proceeds to step 7140. Step 7140 includes: This is the same as step 7040 described above.

[0142] In a variation of method 7100, after test 7138, a second test of the value of resistance to flow is performed. If this value exceeds the "high" threshold and step 7138 If the cannula falls below the threshold used in the The cannula projection may return an indication value, which indicates whether the cannula projection is in contact with the patient 1000. This indicates a near seal inside the nose.

[0143] Step 7170 may be performed if the patient 1000 is in a state of choking for an extended period of time or if the nasal passages are blocked. The test in step 7145 or step 7155 (which may occur if the Step 7170 may be reached if the test in fails. Return it for an indication to indicate that the patient 1000 is not using high flow therapy. Step 7160 is reached if the test in step 7155 passes and sets the value of "in use" A status indication is returned to indicate that the patient 1000 is using high flow therapy.

[0144] In a variation of the method 7100 for monitoring high flow therapy, The "return" steps 7115, 7137 and 7140 respectively return "disconnection" and "blockage". Instead of step 713, a test can be performed for each of the status indications. 7 will not return a "disconnected" status indication, but will instead return an unsealed patient interface. A separate test may be initiated to disconnect the device 3800 from the patient 1000.

[0145] 8.4.3.3 Calibration of the circuit model The circuit model 6100 is a linear resistance 613 for the air circuit, interface and leakage path. 0, 6150, and leakage resistor 6140 respectively. The force drop is nonlinearly dependent on the air flow rate passing through each nonlinear impedance. Each of these impedances can be characterized as In order to achieve this, a multi-stage calibration can be performed. At each stage, at least Two different values ​​are applied and the corresponding measurements of the total flow rate Qt are made. and measurements are used to create a polynomial that relates the pressure drop across the impedance to the flow rate through it. The following series of calibration steps may be used, each of which adjusts the configuration of the air circuit and The corresponding impedances that can be characterized by this are listed below. The impedance provided allows for the next stage of calibration / characterization. Interface disconnected from the air circuit: corresponds to the resistive element 6130 Air circuit impedance. An interface connected to the air circuit and disconnected from the patient: a resistive element Interface impedance corresponding to 6150. - Air circuits and interfaces connected to the patient, "self-occlusion" of the patient: The leakage impedance corresponding to the resistor element 6140.

[0146] 8.4.3.4 Estimation of patient parameters Inductors (not shown) in series with these elements and parameters that can be derived from these values Data (e.g., (the reciprocal of the square root of the product of inertance and compliance divided by 2π) (equal to the value calculated by dividing the resistance by the inertance by 2π) Attenuation) to measure patient 1000 parameters (e.g., airway resistance 6125, pulmonary compliance 6135, the airway "inertance" modeled by the circuit model 6100) In order to estimate such parameters, the source 6110 is a constant servo control value superimposed on the servo control value. It has a more "active" component, either in terms of the number of breaths per unit time or in terms of the number of breaths per unit time. This component of activity can be, for example, the interference at specific frequencies or broadband noise. The resulting response of the total flow Qt to the device pressure Pd The analysis of the activity components of the above may allow prediction of one or more of the above patient parameters. The non-patient elements (6130, 6150 and 6140) of the circuit model 6100 are generated. This process is greatly aided if has been characterized by calibration as described above.

[0147] 8.4.3.5 Two-nostril model FIG. 6c illustrates a patient breathing high-flow therapy through an unsealed patient interface 3800. The electrical circuits forming a more sophisticated model of the RT device to be delivered to the patient 1000 receiving The electric circuit model 6200 is a circuit diagram of the electric circuit model 6100. Same as their respective counterparts 6110, 6120, 6120, 6125, 6130 and 6135 However, the elements 6210, 6220, 6225, 6230 and 6235 are The tract model 6200 uses the interface resistor 6150 as an unsealed patient interface. Two separate resistors 625 that model the left and right nasal protrusions of face 3800, respectively. The leakage resistance 6140 is also divided into left and right nostril leakage resistances 620a and 6250b. 40a and 6240b, respectively. Variation of resistors 6260a and 6260b models the resistance of the left and right nasal passages, respectively. The total flow Qt is the flow through the left process The flow rate Qa passes through the right projection and the flow rate Qb passes through the right projection.

[0148] Simplified model 6200 for extremely low nasal passage resistance 6260a and 6260b Then, interface resistor 6150 is equal to resistors 6250a and 6250b in parallel. , leakage resistance 614 equal to left and right nostril leakage resistances 6240a and 6240b in parallel 0 together with the model 6100. However, for example, due to nasal circulation, nasal passage resistance 6260a If either 6260b or 6260c cannot be ignored, the above does not apply. The method of determining and monitoring determines the usage and status indications at a given time. It is also possible to apply the two nostril model 6200, but different thresholds than those mentioned above may also be implemented. However, to characterize the individual nostril and leak resistance at any given time requires refining the multi-step calibration process described above: Interface disconnected from the air circuit: corresponds to the resistive element 6230 Air circuit impedance. Interface connected to air circuit and disconnected from patient, right prong closed C: Left proximal impedance corresponding to resistive element 6250a. Interface connected to air circuit and disconnected from patient, left prong closed C.: Right proximal impedance corresponding to resistive element 6250b. The air circuit and the interface connected to the patient, the right nostril was "self-closing" Patient: Leakage impedance of the left nostril corresponding to resistive element 6240a. The air circuit and the interface connected to the patient, the left nostril was "self-closing" Patient with: Leakage impedance of the right nostril corresponding to resistive element 6240b.

[0149] After adding the “active” components to the source 6110 with each nostril self-occluded, the active components Analysis of the components and the resulting total flow rate Qt reveals that the Along with the patient parameters, resistance elements 6260a and 6260b are This allows estimation of the left and right nasal passage impedances.

[0150] 8.5 Humidifier In one form of the present technology, absolute relative to atmospheric pressure of air or gas for delivery to a patient. To vary the humidity, a humidifier 5000 (e.g., as shown in FIG. 5a) is provided. Typically, a humidifier 5000 is used to increase the absolute humidity and the airflow (atmospheric humidity). The relative temperature is increased prior to delivery to the patient's airways.

[0151] The humidifier 5000 includes a humidifier reservoir 5110, a humidifier inlet 500 for receiving a flow of air. 2, and a humidifier outlet 5004 for delivering a flow of humidified air. In some embodiments, as shown in Figures 5a and 5b, the inlet of the humidifier reservoir 5110 and the outlet may be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may include a humidifier base 5006. The device may be adapted to receive a reservoir 5110 and contain a heating element 5240. The humidifier reservoir 5110 may include a conductive region 5120. The conductive region 5120 may To allow efficient heat transfer from the thermal 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 form, the humidifier 5000 is configured to receive a humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a The reservoir dock 5130 holds the reservoir 5110 within the humidifier reservoir dock 5130. The locking mechanism may include a locking feature such as a locking lever 5135 configured to lock the locking mechanism in place.

[0153] 8.6 Glossary For purposes of this disclosure, in certain embodiments of the present technology, one or more of the following definitions may be used: In other aspects of the technology, other definitions may also apply.

[0154] 8.6.1 General Air: In certain forms of the present technology, air may mean the atmosphere, in other forms of the present technology In this context, air refers to a combination of other breathable gases (e.g., oxygen-rich air). possible.

[0155] respiratory pressure therapy delivery of air to the entrance of the airways at a therapeutic pressure that is continuously positive relative to the atmosphere To deliver.

[0156] Nasal Continuous Positive Airway Pressure (CPAP) Therapy: A method of providing therapeutic pressure throughout a patient's breathing cycle. In some forms, the pressure at the entrance to the airway is constant throughout the During inhalation the pressure rises slightly and during inhalation the pressure drops slightly. , which varies during different respiratory cycles of the patient (e.g., an indication of partial upper airway obstruction). and is decreased in the absence of an indication of partial upper airway obstruction) .

[0157] Patient: A person with or without a respiratory disease.

[0158] Automatic positive airway pressure (APAP) therapy: In response to the presence or absence of indications of SDB episodes For example, the therapeutic pressure can be continuously adjusted between minimum and maximum limits during a breath. PAP therapy.

[0159] 8.6.2 Phases of the Respiratory Cycle Choking: According to some definitions, choking is the flow dropping below a certain threshold for, say, 10 seconds. Obstructive choking is said to have occurred when the patient is unable to It is said to refer to a condition in which the airway is blocked and air cannot flow, despite the patient's efforts. Central apnea is characterized by a decrease in respiratory effort or a loss of breathing effort despite a patent airway. It is said to refer to a state in which choking is detected due to the absence of inhalation efforts. It is said to refer to a condition in which reduced or absent force occurs simultaneously with airway obstruction.

[0160] Breaths per unit time: The number of spontaneous breaths a patient takes per unit of time, usually per minute. It is measured in respiratory rate.

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

[0162] Effort (breathing): Respiratory effort is the movement made by a person trying to breathe spontaneously. It is said to refer to.

[0163] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0164] Flow limitation: Flow limitation is when an increase in patient effort does not result in a corresponding increase in flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow Flow limitation during the expiratory portion of the respiratory cycle can be described as inspiratory flow limitation. When it occurs, the flow limitation can be described as expiratory flow limitation.

[0165] Hypopnea: Preferably, hypopnea refers to a reduction in flow, not an interruption in flow. In this condition, hypopnea occurs when flow reduction below the threshold velocity continues for a sustained period. If hypopnea is detected due to a decrease in respiratory effort, central respiratory failure is said to have occurred. A decline is said to have occurred. In adults, if any of the following occurs: May be considered as hypopnea: (i) A 30% decrease in patient respiration for at least 10 seconds plus associated 4% desaturation, or; (ii) A reduction in patient respiration (less than 50%) lasting for at least 10 seconds and associated desaturation is at least 3% or awakening occurs.

[0166] Hyperventilation: An increase in flow 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 called the respiratory cycle. It is taken as the intake part of the culvert.

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

[0169] Positive End-Expiratory Pressure (PEEP): The pressure above the atmosphere in the lungs that exists at the end of expiration. There is.

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

[0171] Respiratory flow, airflow, patient airflow, respiratory airflow (Qr): these synonymous terms are: This may be understood to refer to an estimate of the respiratory airflow of an RT device, usually expressed in liters per minute. In contrast to "true respiratory flow" or "true respiratory airflow," which is the actual respiratory flow of the patient measured Used.

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

[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): The time between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the next respiratory flow waveform. The total duration between the start of the inspiration segment and the

[0176] Typical recent ventilation: Ventilation values ​​that tend to cluster together over a given time scale ( i.e., the degree of central tendency of the most recent ventilation values).

[0177] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. Flow levels increase slightly with increasing pressure difference over the lateral airway (Starling resistor behavior) The present invention may be associated with a flow-limiting condition that may increase or decrease in blood flow.

[0178] Ventilation: The degree of total gas exchanged by the patient's respiratory system. may include one or both of the inhalation and exhalation flows per unit time. When expressed as a quantity, this quantity is often called "minute ventilation." The amounts are sometimes simply given as amounts, but are understood as amounts per minute.

[0179] 8.6.3 RT Deviceparameters Flow Rate: The instantaneous volume (or mass) of air delivered per unit time. (Abbreviated form of "flow rate" (Sometimes referred to simply as "flow"). Flow and ventilation are quantities of the same size or or mass, but flow is measured over a much shorter period of time. When mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). Therefore, when we talk about flow, we are referring to a vector quantity (i.e., one that has both magnitude and direction). When referred to as a signed quantity, flow is the amount of air that is expelled during the inspiratory portion of the patient's breathing cycle. can be nominally positive for 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 a range of units (e.g., cmH 2O, gf / cm 2 , hectopascal. 1cmH2O is 1g-f / cm 2 is equal to (Approximately 0.98 hectopascals). In this specification, unless otherwise specified, pressure is , given in cmH2O. Pressure in the patient interface (Patient Interface Face pressure) given by the symbol Pm, and the pressure at the outlet of the RT device (device Pressure) is given by the symbol Pd.

[0181] 8.7 Other Considerations A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owners reserve the right to make, distribute, and use of the material in any form whatsoever. The reproduction by any person of this patent document or this patent disclosure by facsimile does not constitute a copy of the patent file of the Patent Office. If it is something that is written in the letter or record, there is no objection if it is for a specific purpose, but there are no other purposes. All rights reserved.

[0182] Unless otherwise clearly indicated by the context and unless a range of values ​​is provided, the lower limit 1 / 10 of a unit, between the upper and lower limits of the range, and any other stated value in the stated range. It is understood that each of the intervention values ​​for the intervention range is included in the present technology. The upper and lower limits of these intervention ranges specifically exceed the limits of the stated ranges. If the range described includes one or both of these limits, In this case, ranges exceeding either or both of these stated limits are also encompassed by the present technology.

[0183] Additionally, the value or values ​​herein, when implemented as part of the present technology, may be used interchangeably with other Unless otherwise specified, such values ​​may be approximated and may vary as practical technical practice permits or requires. It is understood that such values ​​may be used to any appropriate degree of significance.

[0184] Unless otherwise stated, all technical and scientific terms used herein are intended to be understood as meaning those to which the present technology pertains. The term "a" has the same meaning as that generally understood by a person skilled in the art. Any methods and materials similar or equivalent to the materials may be used in the practice or testing of the present technology. Although a limited number of exemplary methods and materials can be used in any of the above applications, the methods and materials are described herein. will be done.

[0185] Certain materials are described as being suitable for use in the construction of the components, but the properties Similar and obvious alternative materials may be used as substitutes. Insofar as any and all components described herein are manufacturable, they should be understood as such. Therefore, they can be manufactured collectively or separately.

[0186] As used herein, in the appended claims, the singular form "a" "an" and "the" include their plural equivalents unless the context clearly indicates Please note that

[0187] All publications mentioned herein are incorporated by reference in their entirety for all purposes, including, but not limited to, the methods and / or methods that are the subject of these publications. or disclosure and description of the materials, which are incorporated by reference. Any disclosures herein are provided solely for their disclosure prior to the filing date of this application. The contents of these publications are not intended to be construed as a construed limitation on the present invention, nor are they intended to be construed as a construed limitation on the present invention. Further, the publication dates stated should not be construed as an indication of the actual publication dates. may differ and should be checked separately.

[0188] Moreover, in interpreting this disclosure, all terms shall be used in the broadest reasonable manner consistent with the context. For details, see "comprises" and "compris The term "ing" is not intended to refer exclusively to any element, component or step. The elements, components or steps described should be interpreted as if they were not explicitly stated. Indicates that it may be present, utilized, or combined with an element, component, or step.

[0189] Headings used in the detailed description are for the convenience of the reader and are intended to guide the reader through the present disclosure or should not be used to limit what may appear in the claims as a whole. These headings should not be used to interpret the scope of a claim or a claim limitation. should not be used in any manner whatsoever.

[0190] Although the technology herein has been described with reference to specific embodiments, these embodiments It should be understood that the above embodiments are merely illustrative of the principles and applications of the present technology. In some cases, the terms and symbols may indicate specific details that are not necessary for the practice of the present technology. For example, the terms "first" and "second" are used, unless otherwise specified. These terms are not intended to denote any order but are used to distinguish separate elements. Further, the process steps in the method may be described or illustrated in an orderly manner. Although the present invention may be described in order, such order is not required. The order can be changed and / or aspects can be performed simultaneously or even synchronously Recognize that.

[0191] Thus, numerous variations may be made in the illustrative examples without departing from the spirit and scope of the present technology. It should be understood that further examples are possible and other arrangements may be devised. [Explanation of symbols]

[0192] patient 1000 Bedmate 1100 Patient Interface 3000 Closed formation structure 3100 Cavity room 3200 Structure 3300 Ventilation hole 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 Components 4100 Air Filter 4110 Inlet Air Filter 4112 Outlet Air Filter 4114 Inlet muffler 4122 Exit muffler 4124 Pressure Generator 4140 Blower 4142 Motor 4144 Air Circuit 4170 Extra oxygen 4180 Electrical Components 4200 Printed Circuit Board Assembly 4202 power supply 4210 Input Devices 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 Foreign 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 Pulmonary Compliance 6035 Interface resistance 6050 Electrical Circuit 6100 Voltage Source 6110 AC Voltage Source 6120 Airway Resistance 6125 Air circuit resistance 6130 Pulmonary Compliance 6135 Leakage resistance 6140 Interface resistance 6150 Electrical Circuit 6200 Voltage Source 6210 AC Voltage Source 6220 Airway Resistance 6225 Air circuit resistance 6230 Pulmonary Compliance 6235 Left nostril leakage impedance 6240a Right nostril leakage impedance 6240b Left protrusion impedance 6250a Right protrusion 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. 1. A method for determining whether high flow therapy is being used by a patient, the method comprising: Evaluation of one or more signals in a controller associated with the respiratory therapy device determining the one or more signals from the sensors; and transmitting the one or more signals from the respiratory therapy device to an air circuit; The characteristics of the airflow being delivered along the determining whether the measured respiratory rate includes significant variation within a band of respiratory rate per hour; and outputting whether high flow therapy is being used by the patient based on said determining. generating a reading in the controller.

2. The generating step comprises determining whether the characteristic is a significant difference within a band of the number of breaths per unit time. When a determination is made that the patient has a high level of variability, the patient is not deemed to have been using high-flow therapy. The method of claim 1 , further comprising generating the output reading indicative of

3. The determining comprises: said breaths per unit time of said signal indicative of said characteristic over a window of predetermined duration. Calculating the magnitude of variation within the frequency band; and determining whether the magnitude of the variation is greater than a magnitude threshold. Method of posting.

4. The calculation results in an approximate upper limit and a lower limit for the number of breaths per unit time for a human at rest. applying a bandpass filter to the signal having a cutoff frequency of at least one lower limit. The method of claim 3 .

5. The method of claim 4 , wherein the magnitude of the variation is the standard deviation of the window.

6. The calculating step includes:

4. The method of claim 3, further comprising calculating the power of the Fourier transform spectrum of said signal. 。

7. The magnitude of the fluctuation in the signal varies significantly as the window slides forward. and generating the first and second digits based on the determining. The method according to claim 3 .

8. It is determined that the magnitude of the fluctuation significantly changes as the window slides forward. When the generating is performed, the generating is an indication that high flow therapy is being used by the patient. The method of claim 7 further comprising generating said output reading.

9. The determining comprises: Calculating the degree of variation of the magnitude of said variation over a further window of a given duration. To do, and determining whether the degree of variability is greater than a magnitude variability threshold. The method described above.

10. The method of claim 9 , wherein the measure of variation is a variance.

11. 11. The airflow characteristic of claim 1, wherein the airflow characteristic is a total flow rate of the airflow. The method according to one aspect.

12. Calculate the resistance to flow from the total flow rate of said air flow and the pressure of said air flow. The method of any one of claims 1 to 10, further comprising:

13. 13. The method of claim 12, wherein the characteristic of the air flow is a resistance to the flow. 。

14. determining whether the resistance to flow is within a predetermined range; The method of claim 12 , wherein the generating is further based on the determining.

15. generating said resistance to flow if it is determined that said resistance to flow is not within said predetermined range; generating the output reading indicating that high flow therapy is not being used by the patient. The method of claim 14.

16. If the resistance to flow is determined to be below the lower limit of the predetermined range, generating the output indication that the air circuit is disconnected.

14. The method according to claim 14.

17. If the resistance to flow is determined to be above the upper limit of the predetermined range, 15. The method of claim 14, wherein said step of generating said output indication indicates that said air circuit is occluded. The method described.

18. If the resistance to flow is determined to be above the upper limit of the predetermined range, the controller based on said determining, outputting an indication that said patient interface is too large. The method of claim 14 further comprising generating.

19. The calculating step comprises: Cut-off values ​​are approximate upper and lower limits of the number of breaths per unit time for humans at rest. A bandpass filter having a filter number of 1 / 2 is applied to the total flow rate and the pressure to obtain a bandpass filter. Generates filtered device pressure and bandpass filtered total flow To do, The bandpass filtered device pressure is and dividing by the total flow rate measured.

20. 20. The method of claim 19, wherein the pressure is a pressure at an outlet of the respiratory therapy device. Law.

21. Repeating the generation of said output readings to obtain a plurality of generated output readings of usage of high flow therapy. Generating, A time series of generated output indications of high flow therapy usage for the patient is and storing in a record of the chronological usage of the method any one of claims 1 to 20. The method according to one aspect.

22. generating a compliance report based on said record of usage of said high flow therapy.

22. The method of claim 21 further comprising:

23. adjusting parameters of the high-flow therapy based on the record of usage of the high-flow therapy.

22. The method of claim 21, further comprising:

24. 24. The method of claim 23, wherein the parameter is a therapeutic flow rate.

25. generating an alert based on the record of usage of the high flow therapy.

22. The method according to claim 21.

26. and comparing the characteristic of the air flow to a threshold value, the generating further comprising: The method of any one of claims 1 to 25, further based on determining.

27. The characteristic is a total flow rate of the air flow, and the generating step is a step of determining whether the total flow rate is greater than a flow rate threshold. If it is determined that the value is less than the threshold, a notification is sent to the patient indicating that high-flow therapy is not being used by the patient.

27. The method of claim 26, further comprising generating said output reading.

28. The characteristic is a pressure of the air flow, and the generating step is performed when the pressure is below a pressure threshold. If it is determined that the respiratory therapy device is not operational, the output indication is set to "off." The method of claim 26, wherein

29. and inferring a respiratory rate per unit time from the signal indicative of said characteristic.

29. The method according to any one of items 1 to 28.

30. The controller determines whether high flow therapy is being used by the patient based on the output indication. The method according to claim 1 further comprising controlling a change in the operation of the respiratory therapy device based on the change in the operation of the respiratory therapy device.

29. The method according to any one of claims 29 to 30.

31. The change in operation of the respiratory therapy device causes the 31. The method of claim 30, wherein the characteristics of the air flow are changed.

32. 1. A device for delivering high flow therapy to a patient, the device comprising: To generate airflow along the air circuit to an unsealed patient interface a servo controlled blower configured in accordance with claim 1; a central controller configured to control the servo-controlled blower; configured to generate one or more signals indicative of respective characteristics of the air flows being generated. one or more transducers; 13. A processor comprising: receiving said one or more signals; The air flow characteristic indicated by one of the one or more signals is determining whether the control includes significant variation within the band of respiratory rate per day; and In response to said determining, generating an indication of whether high flow therapy is being used by said patient. and a processor configured to:

33. 33. The method of claim 32, wherein the processor is the central controller.

34. The processor is a remote external computer configured to communicate with the central controller.

33. The method of claim 32, wherein the imaging device is disposed within a viewing device.

35. 1. A device for delivering high flow therapy to a patient, the device comprising: A flow circuit that generates airflow along the air circuit to an unsealed patient interface. Means and; means for controlling said flow means; means for generating one or more signals indicative of respective characteristics of said air flows being generated; means for receiving said one or more signals; The air flow characteristic indicated by one of the one or more signals is means for determining whether the respiratory rate band includes significant variation within the band; In response to the determination, generating an indication of whether high flow therapy is being used by the patient. and a means for detecting the presence of the target object.

36. 1. A high flow therapy system comprising: an unsealed patient interface; an air circuit configured to connect to the unsealed patient interface; ； a servo-controlled blower configured to generate a flow of air along the air circuit; a central controller configured to control the servo-controlled blower; configured to generate one or more signals indicative of respective characteristics of the air flows being generated. one or more transducers; 13. A processor comprising: receiving said one or more signals; The air flow characteristic indicated by one of the one or more signals is determining whether the control includes significant variation within the band of respiratory rate per day; and In response to said determining, generating an indication of whether high flow therapy is being used by said patient. and a processor configured to:

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