High-flow therapy device

Abstract

To provide medical devices, methods and apparatuses for one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders.SOLUTION: The methods and apparatuses generate a signal representing an estimate of the flow rate of the gas flow from a respiratory therapy device. The methods include receiving, in a controller, signals generated by a set of sensors. The controller is configured to compute an entrained air density function and generate the estimate signal based on a function of measurement of pressure and frequency and the entrained air density function. The entrained air density function applies signals from additional sensors to compute atmospheric density. Then, control operations of the therapy device are based on the estimated signal, which is applied to assess the accuracy of a signal from a flow sensor.SELECTED DRAWING: Figure 7

Description

[Technical field]

[0001] 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application is a joint venture with U.S. Provisional Patent Application No. 62 / 880,533 (filed July 30, 2019). The present application claims the benefit of US Pat. No. 6,399,433, filed on Oct. 23, 2003, the entirety of which is incorporated herein by reference. do.

[0002] 2. Technology Background 2.1 Technology field This technology is intended to screen, diagnose, monitor, treat, prevent and improve respiratory-related diseases. The present technology relates to one or more medical devices or apparatus and uses thereof (e.g., , flow estimation (e.g., assessing the accuracy of a flow sensor, detecting system or respiratory conditions, etc.) and for controlling a sensing or movement or both. Such processes may be affected in the absence of a flow sensor or a properly operating flow sensor. It can be implemented as follows. [Background technology]

[0003] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways. do.

[0004] 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. "Respiratory Physiology," John B. .West, Lippincott Williams & Wilkins, 9th edition , 2011 issue.

[0005] There are a variety of respiratory diseases. Certain diseases have specific symptoms (e.g., apnea, The condition may be characterized by hyperventilation (hyperventilation and hypopnea).

[0006] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) that causes breathing problems during sleep. It is characterized by the development of an abnormally small upper airway during sleep. A combination of normal deficiencies in muscle tone in the airway and tongue region, the soft palate and the posterior oropharyngeal wall These conditions cause affected individuals to stop breathing, typically for 30 to 120 seconds. The result is excessive daytime sleepiness, sometimes as many as 200 to 300 times a night. This condition is common and can lead to cardiovascular disease and brain damage. It is particularly prevalent in middle-aged, overweight men, but patients are asymptomatic. See issue 0 (Sullivan).

[0007] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. A disorder of the patient's respiratory regulator that results in a 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 because of repeated hypoxia. In some patients, CSR can Involves repeated sleep-wake episodes that cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones). stomach.

[0008] Respiratory failure is a general term for respiratory diseases in which the patient experiences a metabolic activity that is significantly higher than that at rest. In this case, the patient will not be able to ventilate sufficiently to balance the CO2 in his / her blood. Respiratory failure includes all of the following disorders:

[0009] Obesity hypoventilation syndrome (OHS) is a condition characterized by severe obesity and hypoventilation in the absence of other known causes of hypoventilation. It is defined as a combination of chronic hypercapnia upon awakening. Symptoms include dyspnea, difficulty breathing, and difficulty breathing upon awakening. These include headaches and excessive daytime sleepiness.

[0010] Chronic obstructive pulmonary disease (COPD) is a group of lower airway diseases that share certain common characteristics. This includes any of the following: increased resistance to air movement, prolonged expiratory phase of breathing Examples of COPD include emphysema and chronic obstructive pulmonary disease. The causes of COPD include chronic smoking (the primary risk factor), occupational exposure, and air pollution. The causes of bronchitis include air pollution and genetic factors. Symptoms include shortness of breath on exertion, chronic cough and phlegm production. There is.

[0011] Neuromuscular diseases (NMDs) affect muscle tissue either directly through intrinsic muscle pathology or indirectly through neuropathology. NMD is a broad term that encompasses a number of diseases and illnesses that impair muscle function. Some are characterized by progressive muscle damage resulting in the inability to walk and being wheelchair bound. This can lead to restriction, difficulty swallowing, and respiratory muscle weakness, ultimately resulting in death from respiratory failure. Muscle disorders can be classified as rapidly progressive and slowly progressive: (i) rapidly progressive disorders: It is characterized by muscle damage that worsens over months and leads to death within a few years (e.g., Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystonia in teenagers (ii) variable or slowly progressive disorders: Muscle Characterized by disabilities (e.g., limb girdle, face-shoulder, and shoulder) and only a small reduction in life expectancy. Symptoms of respiratory failure in NMD include allergic rheumatoid arthropathy, rheumatoid arthropathy, and rheumatoid arthropathy. Increasing weakness, dysphagia, dyspnea on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0012] Chest wall disorders are a group of thoracic deformities that result from ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and are the result of long-term hypercapnia. Scoliosis and / or kyphoscoliosis can be severe. Severe respiratory failure may develop. Symptoms of respiratory failure include dyspnea on exertion, peripheral Edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite There are slump etc.

[0013] A range of treatments are available to treat or ameliorate such conditions. Additionally, otherwise healthy individuals can also benefit from preventative treatment of respiratory disease. However, these suffer from several deficiencies.

[0014] 2.2.2 Therapy Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is, for example, pushing the soft palate and tongue forward toward the posterior oropharyngeal wall. By retracting or retracting the airway, the continuous positive airway pressure acts as a pneumatic splint, Treatment of OSA with CPAP therapy is voluntary. In order to obtain this treatment, such patients may experience discomfort, difficulty in using the devices used to deliver the treatment. Patients may not adhere to treatment if they find it difficult, expensive, or aesthetically unappealing. You may choose to do so.

[0015] Noninvasive ventilation (NIV) is the delivery of ventilatory support to a patient through the upper airway to improve some of the respiratory functions. Assisting a patient in breathing or maintaining adequate oxygen levels in the body by performing partial or total Ventilatory support is provided via a non-invasive patient interface. NIV is used to treat CSR and other forms of chronic obstructive pulmonary disease, including OHS, COPD, NMD, and chest wall disorders. In some forms, these treatments are more comfortable and and efficacy may be improved.

[0016] Patients undergoing non-invasive ventilation, especially while asleep and / or sedated, When this occurs, it often leads to upper airway instability and collapse, such as in OSA. Such instability and collapse can reduce or even destroy the pressure that actually reaches the lungs from the ventilator. or even be ineffective, compromising the effectiveness of ventilation therapy.

[0017] The upper airway is stabilized by maintaining a base positive airway pressure (herein referred to as EPAP). This can result in superimposed ventilatory support. If EPAP becomes ineffective, this can lead to upper airway collapse. If EPAP becomes excessive, the upper airway may be completely stabilized, but comfort may be adversely affected. This can lead to increased mask leakage or even cardiovascular complications. The aim of this study is to avoid the effects of sleep disorders on the upper airway and to maintain stability across sleep states, postures, levels of sedation, and disease progression. The task of selecting sufficient EPAP to generally maintain (known as EPAP titration) The task is well known to be a complex one for experienced clinicians who have studied polysomnography (PSG) in its entirety. A properly titrated EPAP is a great challenge for balancing the extremes. NIV is used worldwide, but does not necessarily prevent all obstructive events. Although it continues to be popular, the benefits of PSG studies on EPAP titration are not available. In more acute settings, noninvasive Recognition of the effect of sleep and sedation on ventilation effectiveness has historically been limited.

[0018] Therefore, EPAP automatically adjusts in response to changes in the upper airway condition of NIV patients. NIV therapy that can perform (i.e., "EPAP auto-titration") But it is desperately needed.

[0019] 2.2.3 Treatment system These therapies may be provided by a therapeutic system or device. The systems and devices may also be used to diagnose a disease without treating it.

[0020] The treatment system consists of a respiratory treatment device (RPT device), an air circuit, a humidifier, and a patient interface. The system may include a data management interface, a data interface, and data management.

[0021] 2.2.3.1 Patient Interface The patient interface may, for example, provide airflow to the airway inlet to aid in the respiratory The airflow may be used to provide the wearer with an interface to the nose or Delivered via a mask to the mouth or both, a tube to the mouth, or a tracheostomy tube to the patient's trachea Depending on the therapy being applied, the patient interface may be, for example, This allows for sufficient dispersion of pressure together with atmospheric pressure for therapy to take place. (For example, about 10 cmH 2 Gas delivery at positive pressure of O In other forms of therapy, such as oxygen delivery, the patient interface cmH 2 Does not contain a sufficient seal to facilitate delivery of gas supply to the airways at positive O pressures There are cases.

[0022] 2.2.3.2 Respiratory Therapy (RPT) Devices Air pressure generators are known in a wide variety of applications, such as industrial scale ventilation systems. However, air pressure generators for medical applications are different from more general air pressure generators (e.g., medical equipment They have specific requirements that cannot be met by conventional equipment (reliability requirements, size requirements, and weight requirements). Even devices designed for medical treatments must be designed with comfort, noise, ease of use, and effectiveness in mind. Defects related to one or more of the following: efficiency, size, weight, manufacturability, cost and reliability. There are cases where this cannot be avoided.

[0023] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System. Stem (manufactured by ResMed Limited). Another example of an RPT device. Respiratory protection devices (e.g., adult and pediatric ventilators) are used. In the case of the Med Stellar® series, multiple conditions (including but not limited to For patients with a range of conditions for the treatment of NMD, OHS and COPD Invasive and non-invasive assistance for independent breathing may be provided.

[0024] ResMed Elisee® 150 ventilator, and ResMedVS The III® ventilator is designed for adult or pediatric patients for the treatment of multiple conditions. These ventilators can provide invasive and non-invasive dependent respiratory support suitable for This allows for volume and pressure ventilation modes with single or dual limb circuits. RPT devices typically consist of a pressure generator (e.g., an electric or motor-operated blower) or compressed gas reservoir) and configured to deliver a flow of air to the patient's airway. In some cases, the airflow supply to the patient's airway is controlled by a pressure setpoint (e.g., The pressure control loop of the controller according to the setpoint or the flow control according to the setpoint The RPT device outlet can be operated at positive pressure (using a flow control loop on the RPT device). It is connected via a circuit to a patient interface as described above.

[0025] The RPT device may be, for example, a high flow therapy device configured to provide high flow therapy. In this regard, some respiratory treatments may include (possibly positive) Delivery of an inspiratory flow profile (superimposed on line pressure) for a target duration In other cases, delivery of a prescribed respiratory volume by inhalation of an inhalant into the patient's airway is contemplated. The interface is "open" (unsealed) to allow flow of conditioned or concentrated gas. Respiratory therapy by the device may be used only as an adjunct to the patient's own spontaneous breathing. High-flow therapy (HFT) refers to the delivery of a continuous, heated, humidified air flow through a sealed Through an open or closed patient interface, throughout the entire respiratory cycle The therapeutic flow rate is the rate at which the patient's peak inhalation rate is maintained at a nearly constant The nominal airflow rate is set to exceed the airflow rate. HFT is used to treat OSA, CSR, respiratory failure, It is used to treat COPD and other breathing disorders. One mechanism of action is This allows for the flushing or washing away of exhaled CO2 from the patient's anatomical dead space. Therefore, providing a high flow rate of air to the airway entrance improves ventilation efficiency. This is sometimes called dead space therapy (DST). Other benefits include (possibly) suppressing secretion. This may result in increased warmth and humidification (due to the benefit of the ventilation) and a gentle increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate may be a profile that varies over the respiratory cycle. can be followed.

[0026] 2.2.3.3 Humidifier Airflow delivery without humidification can lead to drying of the airways. When used with a nasal device and patient interface, humidified gas is produced, reducing nasal mucus. Membrane drying is minimized, increasing patient airway comfort. Additionally, in cooler climates Generally, the application of hot air to the facial area around the patient interface provides better comfort than cold air. A range of artificial humidification devices and systems are known, but medical humidifiers does not meet the special requirements of

[0027] 2.2.4 Monitoring system In general, screening and diagnosis involve identifying a disease by signs and symptoms of the disorder. Screening usually involves determining whether a patient's impairment is severe enough to warrant further investigation. While diagnostics often provide true or false results that indicate a condition, they often provide clinically actionable information. Diagnosis and treatment tend to be one-off procedures, whereas treatment and diagnosis tend to monitor the progression of the disorder. Monitoring can continue indefinitely. Some screening and diagnostic systems , which are only indicated for screening or diagnosis, but some are also used for monitoring It is possible.

[0028] Polysomnography (PSG) is the traditional system for diagnosing and monitoring cardiopulmonary diseases. Typically, system application requires expert clinical staff. In this study, various biological signals (e.g., electroencephalography (EEG), electrocardiography (ECG), Typically, 15 ~20 contact sensors are placed on the body. For PSG of sleep-disordered breathing, Two nights of observation were required in a specialized hospital: the first night was purely diagnostic; The first night was for diagnosis, and the second night was required for titration of treatment parameters by the clinician. Clinical experts base their diagnosis or monitoring of patients on visual observation of the PSG signal. However, if clinical expertise is not available or cannot be paid, Therefore, PSG is expensive and not convenient. It is not suitable for internal diagnosis or monitoring.

[0029] A simpler home screening, diagnostic and monitoring system would consist of a nasal cannula, pressure sensor and The nasal cannula includes a hollow open-ended protruding portion. The prongs are designed to minimize interference with the patient's breathing. These hollow prongs are configured to be inserted into the patient's nostrils in a substantially non-invasive manner. The fluid is then connected to a pressure transducer via a Y-shaped tube. The pressure transducer is placed at the entrance of the patient's nostril. The nasal pressure signal is similar in shape to the nasal flow signal. The nasal pressure signal is generated by a flow transducer wired to a sealed nasal mask. The processing device has been shown to be an adequate proxy for the raw nasal flow signal. , performing a real-time or near real-time analysis of the nasal pressure signal from the pressure transducer; It may be configured to detect and classify SDB events for patient condition monitoring. Similar analyses may be required to perform screening or diagnosis, but not necessarily for screening or diagnosis. The recording means may not be real-time or near real-time. allows for subsequent offline or "batch" analysis for screening or diagnostic purposes. The device is configured to record a nasal pressure signal from the pressure transducer to enable measurement of the nasal pressure.

[0030] Additionally, the decision to implement changes in therapeutic control and / or condition detection may be influenced by the following factors: When monitoring the respiratory status during respiratory therapy, it is useful to obtain measurements of the patient's respiratory flow. Such measurements of patient respiratory flow may be useful. For example, a measure of patient respiratory flow may be derived from a total flow signal provided by the to determine when to deliver the inhalation or exhalation therapy setting to the patient. The device may be used to detect the transition from inhalation to exhalation or the transition from exhalation to inhalation. The patient respiratory flow signal is used to detect and treat patient flow limitation, apnea, hypopnea, and other respiratory-related or sleep disordered breathing. These detected events may be used to detect conditions or events related to breathing. This allows for the assessment of the patient's condition and these detected events can be used to, for example, Performing adjustments (e.g., pressure control parameters used in controlling respiratory treatment devices (e.g., pressure setpoint) or flow control parameters (e.g., flow setpoint) Examples of such adjustments can be found in the following: Examples of such patents are US Patent Nos. 5,704,345 and 10,350,379. For these purposes, the measured flow signal is transmitted via a flow sensor (e.g. a differential pressure transducer or The measurement may be derived from a pneumotachograph or pneumotachograph.

[0031] Improve existing methods and devices or develop new treatment and detection methods and devices. Further methods and devices for estimating a flow signal for development, application, or both. For example, to ensure high-precision performance by breathing apparatus, development of a method for detecting flow and the detection of sensor failures and / or system conditions or respiratory conditions (e.g., in the absence of a flow sensor or in the absence of a properly operating flow sensor, How to monitor or detect sensor accuracy before and / or during sensor use It may be desirable to develop a method for [Prior art documents] [Patent documents]

[0032] [Patent Document 1] U.S. Patent No. 6,532,959 [Patent Document 2] U.S. Pat. No. 5,704,345 [Patent Document 3] U.S. Pat. No. 10,350,379 Summary of the Invention [Means for solving the problem]

[0033] 3. Brief description of the technology

[0034] This technology can be used in screening, diagnosing, monitoring and treating respiratory diseases. This relates to the provision of medical devices that can be used to improve comfort, cost, , having one or more of effectiveness, ease of use and manufacturability.

[0035] Some versions of the present technology include a flow generator and a flow rate of breathable gas associated with the flow generator. The method may include determining an estimate of

[0036] Some versions of the present technology include a device for treating a respiratory condition, comprising: The method may include a controller for generating a signal indicative of an estimate of flow rate of the respiratory therapy fluid. The treatment device may include a motor-operated blower. receiving at said controller from said pressure sensor an electronic signal indicative of a force measurement. The method includes receiving an electronic signal indicative of a measurement of the speed of the motor from a speed sensor to the controller. The method may include receiving an entrained air density function at a controller. The method may include calculating in a controller the estimated flow rate of the breathable gas. generating a signal indicative of a constant value in said controller using a flow estimation function. The flow estimation function is based on (1) a signal indicative of a measurement of the pressure; (b) a signal indicative of the speed of the motor. and (c) a function of said entrained air density function.

[0037] In some versions, the entrained air density function is the air density value and the air density The entrained air density function may include a factor of the air density value and the air density reference value. The entrained air density function may include a ratio of the air density value and the air density reference value. The method may include a second ratio of the breathable gas to the first ratio. The step of estimating the flow rate may further include calculating a motor force, the motor force being calculated based on the determined breathability. An estimate of the flow rate of the gas that can be pumped may be based on the motor force. It may include functions of air pressure values, temperature values ​​and relative humidity values.

[0038] In some versions, the method further comprises: The method may further include evaluating a signal from the sensor. receiving at said controller an electronic signal from an ambient pressure sensor indicative of a measured ambient pressure; said ambient pressure value being a measure of the ambient pressure of said breathable gas. The method may include: receiving an electrical signal indicative of a measurement of a gas temperature of the breathable gas. receiving at said controller a signal from a gas temperature sensor, said gas The temperature value may be a measurement of a gas temperature of the breathable gas, and the method may further comprise: The ambient relative humidity sensor transmits an electronic signal to the controller indicative of the measured ambient relative humidity of the gas. the ambient relative humidity value being received at a sensor in the ambient relative humidity sensor of the breathable gas; The measurement may be a measurement of humidity.

[0039] In some versions, the ambient pressure value, the temperature value, and the relative humidity value The function may include a saturated steam pressure function as a function of temperature. The number may be defined by:

[0040]

number

[0041] Here, Temp local_DegC may be the temperature value. , the function of the temperature value and the relative humidity value is a vapor pressure function according to temperature and relative humidity The vapor pressure function as a function of temperature and relative humidity may include: (b) multiplying the result of the saturated vapor pressure function by the above relative humidity value as follows: It can be defined as follows.

[0042]

number

[0043] where RH local may be the relative humidity value, and Psv(Temp local_ DegC ) may be a function of the saturated vapor pressure as a function of temperature.

[0044] In some versions, the ambient pressure value, the temperature value, and the relative humidity value The function may be defined by:

[0045]

number

[0046] Here, P 0 = 103 hectopascals, T 0 = 15 degrees Celsius or 288.1 degrees Kelvin 5 degrees,

number

number

[0047] In some versions, the flow estimation function may include a set of frequency functions. The set of frequency functions may include a first rotational frequency function, the first rotational frequency function being , a function of the motor speed measurement and the entrained air density function. The power function may include a second rotational frequency function, the second rotational frequency function being a function of the frequency of the motor. The set of frequency functions may include a third rotational frequency function, The third rotational frequency function is a function of the measured speed of the motor and the entrained air density. The first rotational frequency function may be defined by:

[0048]

number

[0049] RPM may be a measure of the speed of the motor;

number

[0050]

number

[0051] RPM can be a measure of the speed of the motor, and C3, C4 and C5 can be empirically derived. In some versions, the third rotational frequency function is given by The above can be defined as follows.

[0052]

number

[0053] RPM may be a measure of the speed of the motor;

number

[0054]

number

[0055] A may be the first rotational frequency function and B may be the second rotational frequency function. , C may be the third rotational frequency function, and Pres_meas may be the pressure sensor The pressure of said breathable gas may be a measure of the pressure of said breathable gas.

[0056] In some versions, an electronic signal indicative of a measurement of the flow rate of said breathable gas is The method may include receiving at the controller from a flow sensor. said electronic signal indicating a measured value of the flow rate of breathable gas and said estimated value of the flow rate of breathable gas. and comparing in the controller a generated signal indicative of the detected temperature. and outputting an output indicator indicative of an assessment of accuracy of the flow sensor based on the comparison. The method may further include generating the air by a motor-operated blower. and determining by said controller based on said output indicator a control parameter for controlling said The method may include modifying the generated signal indicative of the estimate of breathable gas. and setting a control parameter to operate the motor-operated blower based on the received signal. The control parameters may include a pressure setpoint, The input can be one of the following:

[0057] Some versions of the technology include a processor having processor-executable instructions stored thereon. The processor-executable instructions may include a readable medium for operating a motor in a respiratory treatment device. When executed by the processor controller of the automatic blower, the respiratory treatment device and causing the processor to generate an estimate of the flow rate of breathable gas associated with the The processor executable instructions control operation according to any of the methods described herein. The instruction may include:

[0058] Some versions of the present technology may include a respiratory treatment device. The motor-operated blower may be included in the device and adapted to couple to a patient respiratory interface. The respiratory treatment device is adapted to generate a respiratory treatment for the patient. The respiratory treatment device may include a flow of breathable gas through the interface. a pressure sensor configured to generate an electronic signal indicative of a measurement of the pressure of said breathable gas; The respiratory treatment device may include a motor that generates an electronic signal indicative of a measurement of the speed of the motor. The respiratory treatment device may include a velocity sensor configured to generate a The controller may include one or more processors, the motor-operated blower, the pressure sensor, The controller is coupled to the pressure sensor and the velocity sensor. The controller may be configured to receive an electronic signal indicative of a measurement of the motor. The controller may be configured to receive the electronic signal indicative of a measurement of the speed of the motor. The controller may be configured to calculate an entrained air density function. a signal indicative of an estimate of a flow rate of the gas that can be measured using a flow estimation function; The flow estimation function is based on (1) a signal indicative of the pressure measurement; (b) a signal indicative of the motor speed measurement. and (c) a signal indicative of a constant value; and (b) a function of the entrained air density function.

[0059] In some versions, the entrained air density function is the air density value and the air density The entrained air density function may include a factor of the air density value and the air density reference value. The entrained air density function may include a ratio of the air density value and the air density reference value. 31. In some versions of the respiratory treatment device, To determine the estimated flow rate of breathable gas, the controller includes one or more sensors. The device may be further configured to calculate a motor force from the sensor signal, An estimate of the flow rate of the gas that can be pumped may be based on the motor force. The controller may include a function of an air pressure value, a temperature value, and a relative humidity value. It may further be configured to evaluate a signal from the oxygen sensor to calculate an airtightness function.

[0060] In some versions, the respiratory treatment device is adapted to supply the atmosphere of breathable gas. an ambient pressure sensor configured to generate an electronic signal indicative of a measurement of atmospheric pressure; The ambient pressure value may be a measure of the ambient pressure of the breathable gas. The medical device is adapted to generate an electronic signal indicative of a measurement of gas temperature of said breathable gas. a gas temperature sensor configured to measure the gas temperature of the breathable gas; The respiratory treatment device may include an ambient relative humidity sensor, a breathable gas sensor, and a measurement of the relative humidity. the ambient relative humidity value being indicative of a measurement of the ambient relative humidity of the breathable material; The controller may measure the ambient pressure and may be a measurement of the ambient relative humidity of a gas. The controller may be configured to receive an electronic signal indicative of the gas temperature. The controller may be configured to receive the electronic signal indicative of a measurement of the ambient temperature. It may be configured to receive an electronic signal indicative of a measurement of relative humidity.

[0061] In some versions, the ambient pressure value, the temperature value, and the relative humidity value The function may include a saturated steam pressure function as a function of temperature. The numbers may be defined as described herein. The function of the relative humidity value may include a vapor pressure function as a function of temperature and relative humidity. The vapor pressure function according to the relative humidity is (a) the result of the above saturated vapor pressure function according to temperature. and (b) multiplying the result by the relative humidity value as described herein. The function of the atmospheric pressure value, the temperature value and the relative humidity value may be any of the functions described herein. It can be defined as follows:

[0062] In some versions, the flow estimation function of the respiratory treatment device comprises a set of The set of frequency functions may include a first rotational frequency function, The first rotational frequency function is a function of the measured speed of the motor and the entrained air density function. The set of frequency functions may include a second rotational frequency function, The frequency function is a function of the measured speed of the motor. The set of frequency functions is a third a third rotational frequency function, the third rotational frequency function being a function of a measurement of the speed of the motor. and the entrained air density function. The first rotational frequency function is a function of the entrained air density function as described herein. The second rotational frequency function may be defined as described herein. The third rotational frequency function may be defined as described herein. The estimation function may be defined as follows:

[0063]

number

[0064] A may be the first rotational frequency function and B may be the second rotational frequency function. , C may be the third rotational frequency function, and Pres_meas may be the pressure sensor The pressure of said breathable gas may be a measure of the pressure of said breathable gas.

[0065] In some versions, the respiratory treatment device controls the flow rate of the breathable gas. The system may further include a flow sensor configured to generate an electronic signal indicative of a measurement of the above. A controller is adapted to receive the electronic signal indicative of a measurement of the flow rate of the breathable gas. The controller may be further configured to: Comparing the electronic signal with a generated signal indicative of an estimate of the flow rate of the breathable gas. The controller may be further configured to: The controller may be further configured to generate an output indicator indicative of the assessment of accuracy. a controller for operating the motor-operated blower based on the output indicator; The controller may be further configured to modify a control parameter. and operating said motor-operated blower based on said generated signal indicative of an estimate of the possible gases. The control parameter may be further configured to change a control parameter for operating the device. The data can be one of a pressure set point and a flow set point.

[0066] Some versions of the present technology include a respiratory treatment device as described herein. The processor may further include a processor-readable medium having a processor-readable medium thereon. Executable instructions are stored in the processor. The processor-executable instructions are for controlling the motor-operated blower. When executed by one or more processors of the controller, said one or more processors and causing a processor to generate an estimate of the flow rate of the breathable gas, the processor-executable instructions comprising: It includes instructions to control operation according to any of the methods described herein.

[0067] The methods, systems, devices and apparatus described herein include a processor functionality (e.g., processors in special purpose computers, respiratory monitors and controllers) This may allow for improved functionality of the respiratory treatment device (e.g., the controller of the respiratory treatment device). The methods, systems, devices, and apparatus described herein may be used to assess respiratory conditions (e.g., sleep disorder breathing). This allows for improvements in the field of automated management, monitoring and treatment. According to the technical method described in the present application, the reliability of automatic determination of the respiratory flow and the gas flow rate of the respiratory device is improved. This can help address issues related to improving performance.

[0068] Of course, some of the above aspects may form sub-aspects of the present technology. Various combinations of one or both of the various aspects can be used to further enhance the present technology. It may also constitute other embodiments or subembodiments.

[0069] Other features of the present technology are included in the following detailed description, abstract, drawings, and claims. This becomes clear in light of the information available. [Brief description of the drawings]

[0070] 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: contains the following similar elements: 4.1 Treatment system [Figure 1]The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a supply of air at positive pressure from an RPT device 4000. Air from the RPT device may be humidified by a humidifier 5000 and travel along an air circuit 4170 to the patient 1000. 4.2 Respiratory System and Facial Anatomy [Diagram 2] 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. 4.3 Patient Interface [Diagram 3] FIG. 3 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. 4.4 RPT Device [Figure 4A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] FIG. 1 is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology, with upstream and downstream directions indicated. [Figure 4C] FIG. 1 is a schematic diagram of electrical components of an RPT device in accordance with one aspect of the present technology. [Figure 4D] FIG. 4D is a schematic diagram of an algorithm implemented in an RPT device in accordance with one form of the present technology. 4.5 Humidifier [Figure 5A] FIG. 5A is an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] 5B is an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Breath Waveforms [Figure 6A]A typical model of a human respiratory flow waveform during sleep is shown. The horizontal axis is time and the vertical axis is respiratory flow. Because parameter values ​​can vary, a typical breath may have approximately the following values: tidal volume, Vt, 0.5L; inspiratory time, Ti, 1.6 seconds; peak inspiratory flow, Qpeak, 0.4L / sec; expiratory time, Te, 2.4s; peak expiratory flow, Qpeak, -0.5L / sec. The total duration of the breath, Ttot, is approximately 4 seconds. Humans typically breathe about 15 breaths per minute (BPM) with a ventilation, Vent, of about 7.5L / min. The typical duty cycle, Ti, to Ttot ratio is approximately 40%. [Figure 6B] 1 shows the scaled inspiratory portion of a respiratory flow waveform, where the patient is experiencing an example of "classical flatness" inspiratory flow limitation. [Figure 6C] Scaled inspiratory portion of respiratory flow waveform is shown, where the patient is experiencing an example of "chair-shaped" (late flat) inspiratory flow limitation. [Figure 6D] Scaled inspiratory portion of respiratory flow waveform is shown, where the patient is experiencing an example of "inverted chair" (early flattening) inspiratory flow limitation. [Figure 6E] 1 shows the scaled inspiratory portion of a respiratory flow waveform, where the patient is experiencing an example of "M-shaped" inspiratory flow limitation. [Figure 6F] The scaled inspiratory portion of the respiratory flow waveform is shown, where the patient is experiencing a significant example of "M-shaped" inspiratory flow limitation. 4.7 Flow Signal Estimation [Figure 7] 1A-1C are exemplary diagrams illustrating methods, systems that may be used in implementing the generation of a signal for estimating flow (eg, according to methods described in more detail herein). [Figure 8A] 1 is an exemplary flow chart illustrating a process for generating a flow estimation signal based on input signals (eg, a gas pressure signal, a motor speed signal, and a calculated entrained air density function). [Figure 8B] 8 is an exemplary flow chart illustrating a process for generating an entrained air density function for generating a flow estimation signal, such as in the example of FIG. 7. [Figure 8C] 8 is an exemplary process for using a flow estimation signal in a respiratory apparatus (e.g., an RPT device), for example, using the system of FIG. 7. [Figure 9A] 1 includes graphs illustrating a comparison of flow signals measured by a flow sensor and flow estimation signals generated using fan curves of an exemplary RPT device at various altitudes. [Figure 9B] 1 includes graphs illustrating a comparison of flow signals measured by a flow sensor and flow estimation signals generated using fan curves of an exemplary RPT device at various altitudes. [Figure 10A] Included are graphs showing a comparison of both the flow signal measured by the flow sensor and the flow estimate signal generated when using an exemplary RPT device at various altitudes. [Figure 10B] Included are graphs showing a comparison of both the flow signal measured by the flow sensor and the flow estimate signal generated when using an exemplary RPT device at various altitudes. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0071] 5 Detailed Description of the Embodiments of the Present Technology 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 embodiments that may be used. The terminology used herein is for the purpose of describing the specific embodiments described herein. It should also be understood that this is not limiting.

[0072] The following description is provided in conjunction with various embodiments that may share one or more common characteristics or features. One or more features of any one embodiment may be combined with one or more of the other embodiments. It should be understood that the above features can be combined. Any single feature or combination of features in any of the embodiments may further be It is possible to construct an embodiment in which

[0073] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder. It involves delivering air at positive pressure, or at a high flow rate, to the entrance of the airway.

[0074] In certain embodiments of the present technology, a supply of air at positive pressure or high flow is delivered to one or both of the nostrils. is delivered to the patient's nasal passages via both.

[0075] 5.2 Treatment system In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. Alternatively, the device may provide pressurized air via an air circuit 4170 to the patient interface 3000. The RPT device 4000 may include a stent for delivery to the patient 1000. In the present invention, the RPT device may be a high-flow therapy device, which provides a controlled airflow to the patient. Typically, the delivery is to the patient (through an open patient interface (e.g., a cannula)). This is generally done at a rate higher than the normal inspiratory flow rate.

[0076] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the present technology includes a seal-forming structure 31 00, plenum chamber 3200, positioning and stabilizing structure 3300, vent 3400 , a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3 700 functional aspects. In some embodiments, the functional aspects include one or more physical components. In some configurations, the method may be provided by a single physical component. In use, the seal-forming structure 3100 may provide one or more functional aspects. The device is positioned to surround the entrance of the patient's airway to facilitate positive pressure air delivery to the airway. Other patient interface devices may be used depending on the type of therapy provided by the RPT. It can be used as needed.

[0077] 5.4 RPT Devices The RPT device 4000 according to one aspect of the present technology comprises mechanical and pneumatic components. component 4100, an electrical component 4200, and one or more algorithms The RPT device is configured to execute the 4300. The outer housing 4010 is made up of two parts, an upper part 4012 and a lower part 4014. Further, the outer housing 4010 is formed by one or more panels (single or multiple panels). The RPT device 4000 may include one or more The RPT device 4000 includes a chassis 4016 that supports the above internal components. , may include a handle 4018.

[0078] The pneumatic pathway of the pneumatic RPT device 4000 may include one or more pneumatic circuit items (e.g. , inlet air filter 4112, inlet muffler 4122, capable of delivering air at positive pressure A pressure generator 4140 (e.g., a blower 4142), an outlet muffler 4124, and One or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274) It can be seen.

[0079] One or more of the air path items is a removable 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. The chassis 4016 may be supported by or formed as part of the chassis 4016 .

[0080] The RPT device 4000 includes a power source 4210, one or more input devices 4220, a central controller, a therapy device controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more The protection circuit 4250, the memory 4260, the converter 4270, and the data communication interface 4280, and one or more output devices 4290. 00 can be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative, the RPT device 4000 may include more than one PCBA 420. It may include 2.

[0081] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In one alternative, one or more of the following components may be included in each separate unit: The devices may be arranged as a set.

[0082] 5.4.1.1 Air filter(s) An RPT device in accordance with one form of the present technology includes an air filter 4110 or a plurality of air filters. It may include a filter 4110.

[0083] In one form, the inlet air filter 4112 is in the air pressure path upstream of the pressure generator 4140. is placed at the beginning of the

[0084] In one form, the outlet air filter 4114 (e.g., antibacterial factor) is an air pressure blocker. It is disposed between the outlet of the valve 4020 and the patient interface 3000.

[0085] 5.4.1.2 Mufflers In one form of the present technology, the inlet muffler 4122 is a pressure generator in the air pressure path. It is located above 4140.

[0086] In one form of the present technology, the outlet muffler 4124 is a pressure generator in the pneumatic path. 4140 and the patient interface 3000.

[0087] 5.4.1.3 Pressure generator In one form of the present technology, a pressure generator 4 is provided to generate air flow or delivery at positive pressure. 140 is a controllable blower 4142. For example, the blower 4142 may be a volute The drive unit may include a brushless DC motor 4144 having one or more impellers housed in a drive shaft 4146. The fan delivers an air supply of approximately 4 cmH at a rate of up to approximately 120 liters per minute. 2 O~ Approximately 20cmH 2 Positive pressure in the range of O2 or about 30 cmH2O2 or other forms 2 Go to O For the blower, see U.S. Patent No. 7,866,944 and U.S. Patent No. 8,633,466. 8,014, U.S. Patent No. 8,636,479 and PCT Patent Application Publication WO2013 The present invention may be described in any one of the above-mentioned patents or patent applications. , which is incorporated by reference in its entirety.

[0088] The pressure generator 4140 is under the control of the treatment device controller 4240 .

[0089] 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.

[0090] 5.4.1.4 Transducer(s) The converter may be internal to the RPT device or external to the RPT device. The external transducer may be located, for example, on the air circuit or may be connected to the air circuit. The external transducer may form part of the non-contact sensor (e.g., a patient interface). This may take the form of a Doppler sensor that transmits or moves a data RPT device. -Radar movement sensor).

[0091] In one form of the present technology, one or more transducers 4270 are provided upstream or downstream of the pressure generator 4140. One or more transducers 4270 may be located either upstream or downstream, or both. , flow rate, pressure or temperature at a point in the pneumatic path. and may be arranged.

[0092] In one form of the present technology, one or more transducers 4270 are connected to the patient interface 300. It may be placed near 0.

[0093] In one form, the signal from the converter 4270 is filtered (e.g., low pass, high pass or It can be filtered (by bandpass filtering).

[0094] 5.4.1.4.1 Flow Sensors The flow sensor 4274 according to the present technology is a differential pressure transducer (e.g., from SENSIRION In some versions, the technology The procedure may be performed without a flow sensor (e.g., the flow estimation signal is based on other sensor signals (i.e. (i.e., not based on a flow sensor signal).

[0095] In one embodiment, the flow rate (e.g., the total flow rate Qt from the flow sensor 4274, or A signal representing the estimated value or both may be received by the central controller 4230. do.

[0096] 5.4.1.4.2 Pressure Sensors A pressure sensor 4272 according to the present technology can be placed in fluid communication with the air pressure path. The pressure sensor 4272 detects the pressure characteristics of the gas in the pneumatic path (e.g., the pressure characteristics of the gas blower in the RPT). One example of a suitable pressure transducer is the HONEYWE Another suitable pressure transducer is the GENERA LL ASDX series. There are sensors from the NPA series from AL ELECTRIC.

[0097] In one form, the signal from the pressure sensor 4272 is transmitted to the central controller 4230. Therefore, it is received.

[0098] 5.4.1.4.3 Motor Speed ​​Converters In one form of the present technology, the rotation of the motor 4144 or the blower 4142 or both is A motor speed transducer 4276 or sensor may be used to determine the rotation speed. The motor speed signal from the motor speed converter 4276 is provided to the therapy device controller 4240. The motor speed transducer 4276 may be, for example, a speed sensor (e.g., a Hall effect result sensor).

[0099] 5.4.1.4.4 Gas Temperature Sensor In some versions of the present technology, a gas temperature sensor 4275. In such an implementation, the gas temperature sensor (which may generate temperature and flow signals) may be Another sensor (e.g., a Sensi-type temperature sensor or other temperature sensing device) Rion SDP-872 flow sensor (e.g., hot wire sensor) Such a sensor can detect the presence of gas in the pneumatic path of the RPT or the presence of air in the RPT. A signal (e.g., electrons) is generated that indicates the measured gas (air) temperature relative to the gas in the air path. Such measurements may also indicate gas surrounding the pneumatic flow path of the RPT. Such a sensor may be located, for example, on the PCB of the RPT. The temperature may be generated in an analog signal or a digital signal or both, (sampled via a memory containing the temperature values ​​from the measured signal or such sensor signals or both. 4230) by the processor of the controller 4230.

[0100] 5.4.1.4.5 Ambient pressure sensor In some versions of the present technology, an ambient pressure sensor 4277. For example, The ambient pressure sensor of the RPT (e.g., on the PCB of the RPT) measures the ambient pressure (i.e. The sensor is configured to measure the pressure outside the pneumatic flow path of the RPT. the sensed atmospheric pressure may be generated in an analog or digital signal or both; The processor of the controller 4230 (sampled signals or such sensors) The pressure can be accessed via a memory containing ambient pressure values ​​from the pressure sensor signal, or both.

[0101] 5.4.1.4.6 Ambient Relative Humidity Sensor In some versions of the technology, an ambient relative humidity sensor 4279. For example, ,The relative humidity sensor of the RPT (e.g., on the RPT) measures the ,ambient relative humidity (i.e. The sensor is configured to measure the relative humidity (RH) outside the pneumatic flow path of the RPT. The detected relative humidity can be generated in an analog or digital signal or both. The processor in the Controller 4230 (sampled signal or relative humidity value (e.g. via a memory that contains the measurement, e.g., a percentage value from such a sensor signal, or both can be accessed via

[0102] 5.4.1.4.7 Oxygen Sensors Some versions of the present technology may optionally include one or more oxygen sensors (e.g. For example, to generate an oxygen sensor signal 7021. These oxygen sensors are The oxygen concentration of the gas passing through the pneumatic path of the device is determined. In this case, the oxygen concentration of the gas passing through the breathing tube is estimated using an oxygen sensor 7023. An oxygen sensor is a device configured to measure the concentration of oxygen in a gas. Examples of oxygen sensors include, but are not limited to, ultrasonic oxygen sensors, electrical oxygen sensors, chemical oxygen sensors, and the like. In one implementation, the oxygen sensor 7023 is an ultrasonic The oxygen sensor may be an ultrasonic oxygen sensor that includes a wave emitter and an ultrasonic receiver.

[0103] 5.4.1.4.8 Other Motor Parameter Sensor(s) Some versions of the present technology may also include other motor parameter signal(s) 7021 (e.g. For example, determining or sensing at least one of a motor current, a motor voltage, and a motor force. The sensor may optionally include one or more sensors or circuit elements. For example, one or more sense The resistor(s) measure the current and / or voltage supplied to the blower motor. In some versions, for example, the measured current and the Using the known or measured voltage, the instantaneous power of the motor is determined (e.g. by the central control of the device). The power supply voltage can be calculated by the power supply (e.g., current x voltage = power) using a power supply.

[0104] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve is provided between the humidifier 5000 and the air pressure block. The anti-spillback valve may be disposed between the humidifier 5000 and the drain 4020. The fan is constructed and arranged to reduce the risk of the fan being drawn into the airflow (e.g., into the blower motor 4144). and placed.

[0105] 5.4.1.6 Air circuits The air circuit 4170 according to one aspect of the present technology is a conduit or tube that, in use, provides air flow. This consists of two components (e.g., the pneumatic block 4020 and the patient interface The system is constructed and positioned to move between the 3000 and 3000 Gate 3000.

[0106] In particular, the air circuit 4170 is connected to the outlet of the pneumatic block and the patient interface. The air circuit may be referred to as an air delivery tube. There may be separate limbs of the circuit for inhalation and exhalation. In other cases a single limb is used. can be.

[0107] In some forms, the air circuit 4170 may be used to The air circuit may include one or more heating elements configured to heat air in the air circuit. The heating element may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heating wire circuit may be spirally wound around the axis of the air circuit 4170. The heating element may be connected to a controller (e.g., a central controller 4230 or A portion of the air circuit 4170 that includes a heated wire circuit may be in communication with the humidifier controller 5250. Examples are described in U.S. Patent Application No. US / 2011 / 0023874. The entire document is incorporated herein by reference.

[0108] 5.4.1.7 Oxygen Delivery In one form of the present technology, supplemental oxygen 4180 is provided at one or more points in the pneumatic pathway. (e.g., upstream of the pneumatic block 4020), the air circuit 4170 or the patient interface The composition may be delivered to the face 3000 or both.

[0109] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply The power supply 4210 may be internal or external to the external housing 4010 of the RPT device 4000. can be placed in

[0110] In one form of the present technology, the power supply 4210 provides power only to the RPT device 4000. In another embodiment of the present technology, power is supplied to the RPT device 4000 from the power source 4210. and humidifier 5000.

[0111] 5.4.2.2 Input Devices In one form of the present technology, the RPT device 4000 is a device that allows a human to interact with the device. One or more input devices in the form of buttons, switches or dials to enable 220. Buttons, switches or dials are accessed via a touch screen. A button, switch, or other device that can The touch or dial may be physically connected to the outer housing 4010 in one form. Alternatively, a receiver electrically connected to the central controller 4230. may communicate wirelessly with

[0112] In one form, the input device 4220 allows a human to input a value or menu option or the like. The present invention may be constructed and arranged to allow selection of both.

[0113] 5.4.2.3 Central Controller In one form of the present technology, the central controller 4230 controls the RPT device 4000. One or more processors suitable for controlling

[0114] A suitable processor is the ARM® Cortex-M3 from ARM Holdings. x86 INTEL processor, which is a processor based on the x(R)-M processor (e.g., the S32 series of microcontrollers from STMicroelectronics) In certain alternatives of the present technology, a 32-bit RISC CPU (e.g. , STR9 series microcontroller from ST Micro Electronics) or 16-bit Tri-RISC CPU (e.g. manufactured by TEXAS INSTRUMENTS) Processors from the MSP430 family of microcontrollers may also be suitable.

[0115] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0116] In one form, the central controller 4230 is an application specific integrated circuit. In an embodiment, the central controller 4230 includes discrete electronic components.

[0117] The central controller 4230 controls one or more converters 4270 and one or more input devices. The input signal(s) may be configured to receive an input signal(s) from device 4220.

[0118] The central controller 4230 controls the output device 4290, the therapy device controller 42 40, data communication interface 4280 and humidifier controller 5250 The input / output signal may be configured to provide an output signal(s) to one or more of the input / output ports.

[0119] In some forms of the present technology, the central controller 4230 may include any of the components described herein. configured (e.g., non-transitory computer-readable) to embody one or more methods. A computer program stored in a recording medium (e.g., memory 4260) In some embodiments of the present technology, one or more algorithms 4300 are expressed as a program. In this case, the central controller 4230 may be integrated with the RPT device 4000. In some forms of the technology, some methods are performed by a remotely located device. For example, a remotely located device may be configured to receive recorded data (e.g., The ventilator control settings are adjusted based on the analysis of the ventilator’s The respiratory-related event may be determined or detected.

[0120] 5.4.2.4 Clock The RPT device 4000 includes a clock 4232 connected to a central controller 4230. It can be seen.

[0121] 5.4.2.5 Therapy Device Controller In one form of the present technology, the therapy device controller 4240 includes a therapy control module 4240. 330, one of the algorithms 4300 executed by the central controller 4230. Form a part.

[0122] 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 Siles DC motor controller is used.

[0123] 5.4.2.6 Protection circuit The one or more protection circuits 4250 according to the present technology may be electrical protection circuits, temperature or pressure protection circuits, or Both safety circuits may be included.

[0124] 5.4.2.7 Memory According to one aspect of the present technology, the RPT device 4000 includes a memory 4260 (e.g., a non-volatile In some embodiments, the memory 4260 includes a battery-powered static In some forms, the memory 4260 may include volatile RAM. do.

[0125] 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.

[0126] Additionally or alternatively, the RPT device 4000 may include a removable memory 4260. (e.g., memory cards made according to the Secure Digital (SD) standard).

[0127] In one form of the present technology, the memory 4260 may include a non-transitory computer readable storage device. The recording medium functions as a medium on which one or more of the methods described herein are represented. Computer program instructions (e.g., one or more algorithms 4300 (e.g., The method described for flow estimation, which is explained in more detail in the subsection, is recorded. The memory 4260 may include one or more processors for performing one or more of the methods described herein. For data acquired, collected, used or generated when the It may also function as a volatile or non-volatile storage medium for

[0128] 5.4.2.8 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 to network 4282 and / or to a local external communications network 4284 The remote external communication network 4282 may be connected to a remote external device 4286. The local external communication network 4284 may be connectable to local external devices. The device may be connectable to the network 4288.

[0129] In one embodiment, the data communication interface 4280 is connected to the central controller 4230. In another embodiment, the data communication interface 4280 is part of a central control The controller 4230 may be separate from the controller 4230 and may include an integrated circuit or processor.

[0130] In one embodiment, the remote external communications network 4282 is the Internet. The communication interface 4280 is a Wired communication may be used (via the Internet or optical fiber) or wireless protocols (e.g. , CDMA, GSM, LTE) can be used.

[0131] In one embodiment, the local external communication network 4284 is compliant with one or more communication standards (e.g. For example, using Bluetooth or consumer infrared protocols.

[0132] In one embodiment, the remote external device 4286 may include one or more computers (e.g., In one embodiment, the remote external device 42 86 may be a virtual computer rather than a physical computer. A remote external device 4286, such as Access may be possible from

[0133] The local external device 4288 can be a personal computer, a mobile phone, a tablet, or or a remote control.

[0134] 5.4.2.9 Optional displays and output devices, including alarms 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 display.

[0135] 5.4.2.9.1 Display Drivers The display driver 4292 outputs characters, It receives a character, symbol or image as an input and displays these characters, symbols or images on the display 4294. Convert the image into a command to display it.

[0136] 5.4.2.9.2 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 8-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-segment clock is converted into eight logic signals that indicate whether each of the eight segments should be activated to achieve the desired clock speed.

[0137] 5.4.3 RPT Device Algorithm 5.4.3.1 Pre-processing module A pre-processing module 4310 in accordance with one form of the present technology may include a transducer 4270 (e.g., a flow sensor). It receives as input a signal from a pressure sensor 4274 or a pressure sensor 4272 and outputs one or more These output values ​​are then used to calculate the force values ​​of the different modules. The data is used as input to a therapy engine module (e.g., therapy engine module 4320).

[0138] In one form of the present technology, the output values ​​are the interface or mask pressure Pm, respiratory flow Includes quantity Qr and leakage flow rate Ql.

[0139] In various forms of the present technology, the pre-processing module 4310 includes a pressure compensation 4312, Airflow estimation 4314, leakage flow estimation 4316, flow signal estimation 4317 and respiratory flow estimation Contains one or more of the 4318 algorithms.

[0140] 5.4.3.1.1 Pressure compensation In one form of the present technology, the pressure compensation algorithm 4312 calculates the pressure at the outlet of the pneumatic block. A signal indicative of the pressure in the proximal pneumatic path is received as an input. 12 estimates the pressure drop through the air circuit 4170 and through the patient interface 3000 The estimated pressure Pm is provided as an output.

[0141] 5.4.3.1.2 Estimation of air flow rate In one form of the present technology, the airflow estimation algorithm 4314 is The estimated pressure Pm in the patient interface 3000 is received as an input. The air flow rate Qv of the air through the air hole 3400 is estimated.

[0142] 5.4.3.1.3 Estimation of leakage flow rate In one form of the present technology, the leak flow estimation algorithm 4316 calculates the total flow Qt and It receives the ventilation flow rate Qv as an input and provides an estimate of the leakage flow rate Ql as an output. In this case, the leak flow estimation algorithm 4316 estimates the leak flow rate over several respiratory cycles (e.g., about between the total flow Qt and the ventilation flow Qv over a period long enough to include 10 seconds The leakage flow rate Ql is estimated by calculating the average of the differences.

[0143] In one form, the leakage flow estimation algorithm 4316 provides as an output the leakage flow rate Ql. The leak conductance is calculated and the leak flow rate Ql is calculated based on the leak conductance and and pressure Pm, the patient interface 3000 It receives as input the total flow rate Qt, the ventilation flow rate Qv, and the estimated pressure Pm. The vent is a low-pass filtered non-permeable gas equal to the difference between the total flow Qt and the ventilation flow Qv. It is calculated as the quotient of the airflow and the low-pass filtered square root of the pressure Pm. The filter time constant should have a value large enough to include several respiratory cycles (e.g., about 10 seconds). The leak flow rate Ql can be estimated as a function of the leak conductance product and the pressure Pm. do.

[0144] 5.4.3.1.4 Respiratory flow estimation In one form of the present technology, the respiratory flow estimation algorithm 4318 includes total flow Qt, ventilation Receives flow rate Qv and leakage flow rate Ql as input and calculates ventilation flow rate Qv and estimated leakage flow rate Ql The respiratory flow of air to the patient, Qr, is estimated by subtracting Qr from the total flow, Qt.

[0145] 5.4.3.1.5 Flow signal estimation In one form of the present technology, the flow signals are (e.g., total flow Qt, vent flow Qv, and leakage The flow signal is estimated by the flow signal estimation algorithm 4317 (to generate an estimate of the leak rate Ql). The patient's respiratory flow rate Qr can be estimated by multiplying the ventilator flow rate Qv and the estimated leakage flow rate Qr by the This is further done by subtracting Ql from the estimated total flow Qt. The estimation process is described in further detail herein. Such flow signal estimation may include: The flow rate signal from the flow sensor (e.g., when a fault is detected in the operation of the flow sensor) Similarly, such flow signal estimates may be used in place of to detect faults or otherwise verify the accuracy of the flow sensor as described in more detail herein. It can be used to evaluate the

[0146] 5.4.3.2 Treatment Engine Module In one form of the present technology, the therapy engine module 4320 is 3000 and the air flow rate Qr to the patient (derived from, e.g., the flow rate estimation signal) The method receives as input one or more of the following: and provide it.

[0147] In one form of the present technology, the treatment parameter is a treatment pressure, Pt.

[0148] In various embodiments, the treatment engine module 4320 may include a phase determination module 4321, a wave Shape determination 4322, ventilation determination 4323, inspiratory flow restriction detection 4324, apnea detection 4325, Inspiratory M-shape detection 4326, airway patency determination 4327, typical recent ventilation determination 4328, and and one or more of the algorithms for treatment parameter determination 4329.

[0149] 5.4.3.2.1 Phase Determination In one form of the present technology, the phase determination algorithm 4321 is indicative of respiratory flow Qr It receives as input the signal and outputs the phase of the patient's 1000 current respiratory cycle as Φ. provide.

[0150] In some forms, the phase output Φ, known as the discrete phase decision, is a discrete variable One implementation of discrete phase determination is a binary phase determination with values ​​of inspiration or expiration. The output Φ is obtained when the start of spontaneous inspiration and expiration is detected, even if These are expressed as values ​​of 0 revolution and 0.5 revolution, respectively. "Trigger" and "Cycle" The RPT device 4000 effectively performs discrete phase decisions because the trigger point and cycle instants are when the phase changes from expiration to inspiration and from inspiration to expiration, respectively. In one embodiment of a binary phase decision, the phase output Φ is called The suction flow rate Qr exceeds the “trigger threshold” (which triggers the RPT device 4000). When the patient is breathing "spontaneously," the respiratory flow Qr has a discrete value of 0 (indicating inspiration) and when the patient is breathing "spontaneously," the respiratory flow Qr has a discrete value of 1 (indicating inspiration) and when the patient is breathing "spontaneously," the respiratory flow Qr has a discrete value of 2 (indicating inspiration) the RPT device 4000 falls below the "spontaneous cycling threshold" (which causes the RPT device 4000 to "spontaneously cycle" ) at a discrete value of 0.5 revolutions (indicating exhalation). In such an implementation, the trigger and cycle thresholds are given by the trigger and cycle threshold functions These functions may vary over time during breathing according to the Patent Application No. PCT / AU2005 / 000895 (ResMed Limited) ted, published as WO2006 / 000017. The entirety is incorporated by reference.

[0151] In some such implementations, a "no reaction period" after the final trigger instant (denoted as "Timin"), cycling can be avoided, and the final trigger During the interval after the instantaneous period (denoted as "Timax"), spontaneous cycling The values ​​of Timin and Timax must be set to the RPT device. 4000 settings and are hard-coded when configuring, for example, RPT device 4000 Or it may be set by manual input via the input device 4220.

[0152] In another form, known as continuous phase decision, the phase output Φ is a continuous variable. For example, it varies between 0 and 1 revolution or between 0 and 2π radians. The RPT device 4000 performing the above-mentioned operation is configured such that the successive phases reach 0 revolutions and 0.5 revolutions, respectively. When the phase is reached, it may trigger and cycle. The inhalation time Ti and the exhalation time Te are first estimated from the respiratory flow Qr. Then, in the phase Φ is the ratio of the pre-trigger time Ti to the pre-trigger time Ti. The percentage of the expiratory time Te that has elapsed since the moment of the stroke (the most recent of these) is added. is determined as:

[0153] In some embodiments suitable for ventilation treatment (described below), the phase decision algorithm The rhythm 4321 is, for example, a traction even when the respiratory flow Qr is not significant during apnea. As a result, the RPT device 4000 is configured to In the absence of spontaneous breathing efforts, a "back-up breath" is delivered. In what is known as phase-shifted (ST) mode, the phase decision algorithm 432 1 may utilize a “backup rate” Rb. The backup rate Rb is For example, the RPT Device 4000 is a hard-coded setting when you configure the The time may be set by manual input via the input device 4220.

[0154] Phase decision algorithm 4321 (discrete or continuous) with timing The ST mode is implemented using the backup rate Rb in a manner known as backup. The timed backup can be implemented as follows: The trigger decision algorithm 4321 may compare the respiratory flow Qr to a trigger threshold, for example as described above. By detecting the start of inspiration due to spontaneous breathing efforts, the duration of the Backup rate Rb (the interval called the backup timing threshold, Tbacku The onset of spontaneous breathing occurs within a certain interval after the final trigger instant equal to or equal to the reciprocal of p). If not detected, the phase decision algorithm 4321 sets the phase output Φ to a zero value. which triggers the RPT device 4000 to deliver a backup breath. The phase decision algorithm 4321 then determines the respiratory flow rate Qr It attempts to detect the onset of spontaneous exhalation by comparing the back-up time with the cycle threshold. The cycling threshold for paced breathing may be different from that for spontaneous breathing. , spontaneous cycling during backup breathing is of duration T after the final trigger instant This can be avoided within the "non-responsive period" of imin.

[0155] As with spontaneous breathing, spontaneous breathing occurs within Timax seconds after the final trigger moment during backup breathing. If the start of exhalation is not detected, the phase determination algorithm 4321 determines the phase exit. The force Φ is set to a value of 0.5, which cycles the RPT device 4000. The phase decision algorithm 4321 then sets the respiratory flow Qr as the trigger threshold as described above. It attempts to detect the onset of spontaneous inspiration by comparing it with the value

[0156] 5.4.3.2.2 Waveform determination In one form of the present technology, a waveform determination algorithm 4322 determines the entire respiratory cycle of the patient. Provides near constant therapeutic pressure through the

[0157] In another form of the present technology, the waveform determination algorithm 4322 may configure the pressure generator 4140 to Controlled and varying through the phases of the patient's respiratory cycle according to a waveform template A therapeutic pressure Pt is provided.

[0158] In one form of the present technology, the waveform determination algorithm 4322 determines a waveform template Π(Φ ) The waveform template is used by the waveform determination algorithm 4322. Regarding the range of phase values ​​Φ provided by the proposed phase determination algorithm 4321, It has values ​​in the range [0,1].

[0159] In one form, the waveform test is used as a measure for discrete or continuous phases. The template Π(Φ) is a square wave template, which is It has a value of 1 for phase values ​​greater than 0.5 revolutions and a value of 0 for phase values ​​greater than 0.5 revolutions. For a continuous phase, the waveform template Π(Φ) is Includes smoothly curvilinear parts (i.e. smoothly curvilinear for phase values ​​up to 0.5 revolutions) A phase that goes from 0 to 1 (e.g., raised cosine) and exceeds 0.5 revolutions A smoothly curvilinear (e.g. exponential) decline from 1 to 0 for a value.

[0160] In some forms of the present technology, the waveform determination algorithm 4322 is Depending on the 4000 setting, the waveform template Π(Φ) is selected from the waveform template library. Each waveform template Π(Φ) in the library is selected from the lookup table for the phase value Φ. In another embodiment, the waveform determination algorithm 4 may be provided as a lookup table value Π. 322 is a function of a predetermined function form, possibly depending on one or more parameters (e.g., rise time and Using the waveform template Π(Φ) The parameters of the functional form may be predetermined or may be calculated "on the fly". , or may depend on the current condition of the patient 1000.

[0161] This technique is suitable for discrete binary phases of inspiration (Φ=0 rotations) or expiration (Φ=0.5 rotations). In some embodiments, the waveform determination algorithm 4322 determines the waveform from the most recent trigger instant. The waveform template Π is calculated as a function of the discrete phase Φ and time t measured from the In one such embodiment, the waveform determination algorithm 4322 , the waveform template Π(Φ,t) is defined in two parts (inhalation and exhalation) as follows: Calculate.

number

[0162] Here, Π i (t) and Π e (t) is the inhalation part of the waveform template Π(Φ,t) and the exhalation portion.

[0163] In one such embodiment, the inhalation portion of the waveform template, Π i (t) is a combination of two It is a smooth rise from 0 to 1 in successive sections. A linear increase through the first two-thirds of the first half of a parameter known as the "time scale" , A parabolic rise to 1 for the second half of the time scale.

[0164] Such an intake part Π i The "rise time" of (t) is Π i (t) rises to a value of 0.875 It may be defined as the time required to ascend.

[0165] The expiratory portion of the waveform template, Πe(t), is a transition from 1 to 0 in two consecutive parabolic sections. A smooth decline to 0.01, with the inflection point occurring at 25%-50% of the time scale. Qi part Π eThe "fall time" of (t) is Π e (t) required to fall to a value of 0.125 It can be defined as a period of time.

[0166] 5.4.3.2.3 Ventilation determination In one form of the present technology, the ventilation decision algorithm 4323 determines the respiratory flow Qr (which is As previously mentioned, the system receives as input the estimated flow signal (which may be derived from the estimated flow signal) and calculates the current patient ventilation as Determine the Vent measurement shown.

[0167] In some implementations, the ventilation decision algorithm 4323 may compare Vent to the respiratory flow signal. It is calculated as "instantaneous ventilation", Vint, which is half the absolute value of Qr.

[0168] In some implementations, the ventilation decision algorithm 4323 controls the instantaneous ventilation Vint. A low-pass filter with a maximum frequency of approximately 0.10 Hz (for example, a fourth-order Bessel low-pass filter). By filtering the Vent with a Vve filter, the Vent is made into a "high-speed ventilation" ryFast, which corresponds to a time constant of approximately 10 seconds.

[0169] In some implementations, the ventilation decision algorithm 4323 controls the instantaneous ventilation Vint. A low-pass filter with a maximum frequency of approximately 0.05 Hz (e.g., a fourth-order Bessel low-pass filter). By filtering the Vent with a Vve filter, the Vent is made into a "high-speed ventilation" ryFast, which corresponds to a time constant of approximately 20 seconds.

[0170] In some implementations of the present technology, the ventilation decision algorithm 4323 determines whether Vent is an alveolar Alveolar ventilation is determined as a measure of the amount of air that is expended on the gas-exchanging surfaces of the respiratory system at a given time. It is a measure of the actual volume of air that actually reaches the patient's respiratory system. " (i.e., volume where gas exchange does not occur), alveolar ventilation is Less than the "gross" ventilation value produced by the above calculations operating directly and the patient's respiratory capacity It is a more accurate measurement of force.

[0171] In such an implementation, the ventilation decision algorithm 4323 determines whether instantaneous alveolar ventilation is proportional to respiratory flow. The condition where instantaneous alveolar ventilation is zero can be determined as zero or half the absolute value of the quantity Qr. is shown below. When respiratory flow changes from non-negative to negative, or When respiratory flow changes from negative to non-negative, and The respiratory rate is increased over a period of time when the absolute integer value of the respiratory flow Qr is below the patient's anatomical dead space volume. After the sign of the flow rate changes.

[0172] The patient's anatomical dead space volume may be a setting of the RPT device 4000, e.g. This can be hard coded during configuration of the RPT device 4000 or the input device 4220 This can be set by manual input via.

[0173] In some such implementations, the ventilation decision algorithm 4323 may include By low-pass filtering the instantaneous alveolar ventilation with a t may be calculated as "ultra-rapid alveolar ventilation" or "rapid alveolar ventilation" or both.

[0174] In the following description, the word "alveolus" is omitted, but the treatment engine module 4 It is assumed that the 320 is present during some execution of the When "ventilation" and "tidal volume" are mentioned in this document, the references are to alveolar ventilation and This can apply to tidal volumes and alveolar tidal volumes as well as "gross" ventilation and tidal volumes.

[0175] 5.4.3.2.4 Inspiratory flow limitation determination In one form of the present technology, the therapy engine module 4320 determines the extent of flow restriction ( Also referred to as partial upper airway obstruction in the inspiratory portion of the respiratory flow waveform (referred to herein as the "inspiration waveform"). In one embodiment, the method includes: The flow limitation decision algorithm 4324 determines the respiratory flow signal Qr (which, as previously described, is the estimated a flow signal derived from the inhalation waveform and a measurement of the extent to which each inhalation waveform exhibits flow limitation; Provides a constant value as output.

[0176] A normal inspiration waveform is rounded so that its shape resembles a sine wave (see FIG. 6A). With sufficient upper airway muscle tone (or EPAP), the airway essentially functions as a rigid tube. Internally, flow increases in response to increased respiratory effort (or external ventilatory support). In some situations (e.g. sleep, sedation) the upper airway may be exposed to, for example, respiratory effort or even They may also be capable of buckling in response to low internal atmospheric pressure from added ventilation. This can result in a total obstruction (apnea) or a phenomenon known as "flow limitation." The term "restriction" refers to the fact that increased respiratory effort only narrows the airway, resulting in The behavior in which the intake flow is limited at a constant value independent of the force (the "Starling resistor behavior" This results in a flat inspiratory flow curve (see Figure 6B).

[0177] In reality, upper airway behavior is more complex, with upper airway-related inspiratory flow limitation and There is a variety of flow configurations indicative of the presence of more extensive external ventilation support (see Figures 6C-F). Therefore, the flow limitation decision algorithm 4324 determines the following types of inspiratory flow limitation: Namely, “classical flatness” (see Fig. 6B), “chair-like” (see Fig. 6C), and “ "Inverted chair shape" (see Figure 6D). ("M-shape" (see Figure 6E and Figure 6F) is an M-shaped test. The output of the call can be handled separately using the output algorithm 4326.

[0178] 5.4.3.2.5 M-shape detection In one form of the present technology, the treatment engine 4320 module performs one or more algorithms. In one embodiment, the M-shape detection algorithm is Rhythm 4326 receives the respiratory flow signal Qr as an input and calculates the shape of each inspiratory waveform. It provides as output a measurement representing the range.

[0179] Typical recent M-shaped inspiratory waveform for tidal volume or other respiratory direction ventilation values Such an inspiratory waveform is relatively rapid. has steep rises and falls as well as dips or "notches" in the flow and center; The dip is due to flow limitation (see Figures 6E and 6F). As ventilation increases in the axial direction, these waveforms are generally behavioral (i.e., sleep microsensation). the patient is in a state of apnea or exhale) and does not exhibit flow limitation.

[0180] To detect M-shaped waveforms, the M-shaped detection algorithm 4326 is The similarity of the inspiration waveform to the waveform being measured is determined.

[0181] 5.4.3.2.6 Apnea detection In one form of the present technology, the therapy engine module 4320 implements an apnea detection algorithm. Run program 4325 to detect apnea.

[0182] In one form, the apnea detection algorithm 4325 receives the respiratory flow signal Qr as an input. It receives and provides as output a series of events representing the start and end of the detected apnea.

[0183] 5.4.3.2.7 Typical Recent Ventilation Decisions In one form of the present technology, a central controller 4230 receives a current ventilation Vent measurement Take as input a value Vtyp that represents the typical recent ventilation of patient 1000. , execute one or more exemplary recent ventilation decision algorithms 4328.

[0184] A typical modern ventilation Vtyp is calculated based on multiple temporal parameters over several given time scales. The measured values ​​of the current ventilation Vent over a period of time are distributed close together and tend to be clustered. (i.e., a measure of the central tendency of current ventilation measurements over recent history). In one implementation of the recent ventilation decision algorithm 4328, the recent history is on the order of a few minutes. However, in any case, there are times when Cheyne-Stokes growth and decline cycles occur. Typical modern ventilation decision algorithms4328 Determine typical recent ventilation Vtyp using any of a variety of well-known measures of central tendency. This can be determined from a measurement of the current ventilation Vent. One such measurement is the current ventilation is the low pass filter output for the Vent measurement, with a time constant equal to 100 seconds. .

[0185] 5.4.3.2.8 Airway patency determination In one form of the present technology, a central controller 4230 may be configured to determine airway patency by: Executes an airway patency determination algorithm 4327. In some embodiments, The sex determination algorithm 4327 returns either "closed" or "open" It returns the corresponding Boolean value (e.g., "true" for closed and "false" for open).

[0186] 5.4.3.2.9 Determination of treatment parameters In some forms of the present technology, a central controller 4230 controls the therapy engine module. One or more of the other algorithms in Rule 4320 may be used to generate a one or more treatment parameter determination algorithms 432 for determining the above treatment parameters; Execute 9.

[0187] In one form of the present technology, the treatment parameter is an instantaneous treatment pressure Pt. In an embodiment, the treatment parameter determination algorithm 4329 determines the treatment pressure P as follows: Determine t.

number

[0188] The treatment pressure Pt is determined using equation (1) for positive amplitude A and is applied to the RPT device 40 00 as a set point in the controller 4230, the treatment parameters The decision algorithm 4329 oscillates the therapeutic pressure Pt in synchrony with the spontaneous breathing efforts of the patient 1000. That is, the treatment parameters are adjusted based on the typical waveform template Π(Φ) described above. The meter determination algorithm 4329 increases the therapy pressure Pt at the beginning or during inspiration. and reduces the therapeutic pressure Pt at the beginning or during expiration. is the amplitude of the vibration.

[0189] The waveform determination algorithm 4322 uses the waveform template Π(Φ ), the treatment parameter determination algorithm 4329 is a phase determination algorithm The closest lookup table is used to check the current phase value Φ returned from the 4321. By locating the input or by interpolating between two inputs that span the current value of phase Φ. Then, apply equation (1).

[0190] Pressure Support A and Base Pressure P 0 The value of is based on the selected respiratory pressure therapy mode. The therapeutic parameter determination algorithm 4329 may determine the therapeutic parameter.

[0191] 5.4.3.3 Treatment Control Module In accordance with one aspect of the present technology, a therapy control module 4330 includes a therapy engine module 432. 0 treatment parameter determination algorithm 4329 as input. , to deliver airflow from pressure generator 4140 according to these treatment parameters. , controls the pressure generator.

[0192] In one form of the present technology, the treatment parameter is a treatment pressure Pt, and a treatment control module 4330 indicates that the mask pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt. or the interface flow rate F t is the treatment flow rate T F t and controlling the pressure generator 4140 to deliver an air flow from the pressure generator 4140 equal to do.

[0193] 5.4.3.4 Detecting Fault Conditions In one form of the present technology, the central controller 4230 may include one A fault condition detected by one or more of the methods shall be determined to be at least one of the following: It may include at least one of: Power outage (no power or insufficient power) Converter failure detection Failure to detect the presence of a component Operating parameters are outside the recommended range (e.g. pressure, flow, temperature, PaO2) · Failure of a test alert to produce a detectable warning signal. Flow signal from the flow sensor and flow estimation signal from the process for flow signal estimation 4137 Significant inequality with

[0194] When a fault condition is detected, the corresponding algorithm signal is generated by one or more of the following: Signals the presence of a fault. Initiating audible, visual, or kinetic (e.g., vibration) warnings Sending messages to external devices Incident logging Changing control parameters as described in more detail herein

[0195] 5.5 Humidifier In one form of the present technology, the absolute humidity of the air or gas to be delivered to the patient is adjusted to that of the ambient air. A humidifier 5000 is provided for varying the relative humidity (e.g., Typically, the humidifier 5000 humidifies the airflow (ambient air) before delivery to the patient airway. It is used to increase the absolute humidity (relative to air) and to increase the temperature.

[0196] The humidifier 5000 includes a humidifier reservoir 5110 and a humidifier inlet 500 for receiving an air flow. 2 and a humidifier outlet 5004 for delivering the humidified air flow. In some configurations, such as that shown in FIG. 5B, the inlet and The humidifier inlet 5002 and the humidifier outlet 5004 may be, respectively. The humidifier may further include a humidifier base 5006. The humidifier base 5006 may include a humidifier ring. It may be adapted to receive the reservoir 5110 and may include a heating element 5240 .

[0197] 5.6 Respiratory Pressure Therapy Mode Used by the treatment parameter determination algorithm 4329 in one form of the present technology Depending on the values ​​of parameters A and P0 in the treatment pressure equation (1), various respiratory pressure treatment models are available. The download can be performed by the RPT device 4000.

[0198] 5.6.1 CPAP treatment In some embodiments, the pressure support A is equal to zero, so that the therapeutic pressure Pt is equal to the respiratory The base pressure P 0 In this embodiment, CPAP therapy is In this embodiment, the phase Φ Alternatively, the treatment engine module 4320 for determining the waveform template Π(Φ) may be omitted. It is essential.

[0199] 5.6.2 Ventilation treatment In other embodiments, the value of pressure assist A in equation (1) can be positive. Some of the ventilation therapies known as constant pressure support ventilation are: In the embodiment, the pressure support A is set to a predetermined value (e.g., 10 cmH 2 O) is fixed. The fixed pressure assist A is a setting of the RPT device 4000, e.g., 00 configuration or manually entered via input device 4220. In some versions, the pressure can be bi-level, e.g. A higher pressure is delivered when the patient inhales and a lower pressure is delivered when the patient exhales.

[0200] The value of the pressure assist A may be limited to a range defined as [Amin, Amax]. The pressure support limits Amin and Amax are the settings of the RPT device 4000, e.g. This can be hard coded during configuration of the RPT device 4000 or by using the input device 4220 It is set by manual input through the 2 Minimum pressure support Amin at steady state This is on the order of 50% of the pressure support required to achieve the full respiratory effort of a typical patient at . 12cmH 2 The maximum pressure support Amax of O is the amount of oxygen required to perform all of the breathing tasks of a typical patient. Nearly double the required pressure support, helping patients breathe when they stop making voluntary efforts The threshold for determining whether a hazard is present is sufficient to cause discomfort, but below that which would be uncomfortable or dangerous.

[0201] 5.7 Flow Therapy Mode In some versions, the RPT is a flow control loop, e.g., with an estimated flow signal. and a catheter-based airway suction device for suctioning and dispensing air from a patient in an "open" (non-sealing) state. Respiratory therapy is provided by administering conditioned gas or endotracheal gas to the patient's own spontaneous breathing. A controlled flow of rich gas may be provided. In one embodiment, high flow therapy (HFT) is The breathing cycle is performed through an unsealed or open patient interface. The therapeutic flow rate is controlled by a constant value that is maintained throughout the entire patient's body. The nominal flow rate is set to exceed the patient's peak inspiratory flow. , the therapy flow rate may follow a profile that varies over the respiratory cycle.

[0202] 5.8 Flow signal estimation As noted above, a controller or processor (e.g., one or more of the RPTs) may Execution of the process of flow signal estimation 4317 in 4D produces a flow signal estimate (e.g., a flow sensor One such exemplary flow estimation process is shown in FIG. 7. As shown, in the process, the flow estimation unit 7004 (e.g., a central controller using control logic or processor control instructions as described above). A single controller or processor may be used and may include measurements from a set of sensors. A flow estimation function that derives a flow estimation signal 7008 from a set of input signals 7010 In this example, the flow estimation unit 7004 may receive a signal ( For example, data values ​​can be accessed directly from memory and / or sensors. 7008). As shown, the input signals include the operation of the blower and Associated with this is pressure 7012 (e.g., pressure sensor 42 in the pneumatic path of the RPT). 72). The input signal may be associated with a blower motor of the RPT. The input signals may include the motor speed 7014 (e.g., from a speed sensor 4276). , ambient pressure 7016 (e.g., ambient pressure The input signal is related to the gas in the pneumatic path of the RPT. The gas temperature 7018 (e.g., from a gas temperature sensor 4275) may be measured. These input signals are associated with gases external to the pneumatic path of the RPT (e.g., ambient). The ambient relative humidity 7020 (e.g., from an ambient relative humidity sensor 4279) may be measured. In some versions, the input signal is from an oxygen sensor (e.g., oxygen concentration 70 21) or signal(s) from motor parameter sensor(s). Optionally, the parameters may include a motor parameter 7023, a power supply parameter 7024, a power supply parameter 7025, a power supply parameter 7026, a power supply parameter 7027, or both. These input signals are fed from the sensors to generate a simultaneous flow estimation signal repeatedly over time. In addition, some versions In such an estimation signal process, such a signal is calculated from the values ​​stored in the memory. One or more of all of these signals may be used.

[0203] In some examples, the flow estimation unit 7004 may be implemented as follows: The flow estimation unit 700 may perform one or more of the processes shown in the chart. 4 operates in conjunction with the treatment engine and fault condition detection 4340 process shown in FIG. For example, as shown in FIG. 8A, in step or process 8002, In this regard, the flow estimation unit 7004 may, for example, be implemented using one or more sensors and, optionally, the flow estimation unit 7004 may include, for example, ... The input signal (e.g., a measured ambient pressure signal and a measured In step or process 8004, a flow rate estimation signal (a motor speed signal) may be received. Unit 7004 may calculate the entrained air density function. In the flow estimation unit 7004, for example, gas pressure, motor speed and entrained air tightness are A flow estimation function using the degree function may be used to generate the flow estimation signal 7008. to the process of the treatment engine, the fault condition detection engine and the flow estimation unit. In a related manner, the central controller may, in process or step 8008, An output indicator may be generated based on an evaluation of the flow estimate signal or the estimated signal. In some versions, flow estimation is performed using an estimated flow signal (e.g., As described in issued U.S. Patent No. 6,237,593 (ResMed Limited), The motor parameters (e.g., motor force) are used to generate the Such an estimated flow signal may be used, for example, when the flow rate of the system is negative ( For example, one direction from the patient interface (e.g., from the patient) to the flow generator blower. It can be used when moving in a direction.

[0204] In some versions, the oxygen concentration (e.g., using the signal from an oxygen sensor) (a) may be used to determine the estimated flow rate, for example to take into account the concentration of the breathable gas being sensed. For example, if the gas composition of the breathable gas in the system differs from that of the ambient air, The gas may be other than those described (e.g., For example, the gas may be different from the ambient air used in the model for derivation of the entrained air density function. Therefore, the function(s) for generating the estimated flow signal must use this difference or the aborted It may be modified to take into account the use of existing functionality. In this study, multiple entrained air density functions, as described by empirical models, were calculated for different concentrations of The gases used can be derived at the time of design. In the example, the signal from the oxygen sensor is The present invention can function to select an appropriate entrained air density function from among a number of functions (depending on the gas concentration). This allows the selected function(s) to be similar or similarly is assumed to be empirically pre-derived using equivalent gas concentrations.

[0205] Thus, in some versions, for example, the flow rate of the system is positive (e.g., From the flow generator blower to the patient interface (e.g., the patient and the patient interface When the flow rate is estimated in one direction (towards the vent of the gas supply), the flow rate estimation function is performed according to the following formulas and functions: Therefore it can be calculated: The following equations or functions are functions of pressure, velocity and air density:

number

[0206] Where: Flow_est is the generated flow estimation signal, A, B and C are each, for example, at least the rotation frequency (e.g., the measured motor is a frequency-related function of a set of functions of Pressure_meas is the measurement of the pressure generated by the blower (e.g., R (taken by pressure sensor 4272 in the pneumatic path of the PT).

[0207] In one such example, a set of rotational frequency functions may be implemented as follows:

[0208]

number

[0209]

number

[0210]

number

[0211] Where:

[0212] r1, r2, r3, r4, r5, r6 and r7 are constants,

[0213] RPM is the measured motor speed (e.g., revolutions per minute)

[0214]

number

number

[0215] In the exemplary implementation, the constants (A, B, C) of the rotational frequency related function are The temperature can be empirically determined by a fan curve(s) (e.g., a second order polynomial (pressure measurements, flow measurements and RPM measurements) and polynomial modeling These values ​​can be used, at least in part, to correlate with the operation of the RPT's blower. The fan curves at sea level, 2000m altitude and 3000m altitude (e.g., 5 000, 10000, 15000 and 20000 RPM) for example, In one such example, such a constant are 0.00000001, 0.00086500, and 0.000000000, respectively. 05, 0.0000005119, 0.0130975, 0.000000038, 0. It can have values ​​of 000070756 and 0.281905000. The constant value may be different depending on the type and construction of the blower of the RPT device. It will be understood that the values ​​of these constants may vary, for example, as desired in any particular implementation. The number of decimal places may be approximated or otherwise rounded to the appropriate number of decimal places as needed.

[0216] As mentioned above, the flow estimation unit 7004 calculates the reference air density value and the local An entrained air density function is used to which the determined air density values ​​can be related. Such a function is A set of sensors (e.g., a gas temperature sensor 4275, an ambient pressure sensor 4277 and a relative Using a measurement signal from a humidity sensor (e.g., data from a memory representing such a signal), Possible.

[0217] An exemplary process for performing such functionality of the process or step 8004 of FIG. The process is shown in FIG. 8B. In process or step 8022, the central controller Or the processor may receive signals indicative of gas temperature, ambient pressure and relative humidity. In step 8024, the central controller or processor The atmospheric pressure function (Psv) can be calculated in relation to temperature, whereby the measured temperature can be used. In process or step 8026, the central controller or processor: The vapor pressure function (Pv) can be calculated, for example, in relation to temperature and relative humidity, In such a function, the saturated vapor pressure function (Psv) is The vapor pressure function (Pv) is also a function of temperature. In the step 8026, the central controller or processor converts the air density value into a vapor pressure function. (Pv), the saturated steam pressure function (Psv) and the ambient pressure signal.

[0218] For example, in some versions, the saturated vapor pressure function (Psv) is can be executed.

number

[0219] Where:

[0220] Psv is the value of the saturated vapor pressure generated by the saturated vapor pressure function,

[0221] e is Euler's number or other value that approximates such a number to the desired number of digits,

[0222] Temp local_DegC is the measured temperature (e.g., in degrees Celsius or other (based on appropriate thermometric methods).

[0223] K1, K2, and K3 are constants that can be empirically determined, but in some versions In the example, the values ​​are 6.1078, 17.2693882, and 237.4, respectively. These values ​​may, for example, be approximated or otherwise determined in any suitable implementation. It may be rounded to the appropriate number of decimal places as desired.

[0224] In some versions, the vapor pressure function (Pv) can be implemented as .

number

[0225] Where:

[0226] Pv is the value of the vapor pressure generated by the vapor pressure function,

[0227]

number

[0228] Psv is the value of the saturated steam pressure generated by the saturated steam pressure function.

[0229] In the calculation of local air density values ​​in some versions, the entrained air density function is , which is a function of ambient pressure, gas temperature and relative humidity, and may be implemented as follows:

number

[0230] Where:

[0231]

number

[0232] P 0 is 1013.0 hectopascals,

[0233] T 0 is 15.0 degrees Celsius or 288.15 degrees Kelvin,

[0234]

number

number

[0235] P atm_local is generated, for example, by the signal generated by the ambient pressure sensor 4277. is the measured value of the atmospheric pressure of

[0236] Z1 is a constant that can be empirically determined, and in some versions is, for example, 0 0.3783 or other approximation thereof (e.g., as desired in any particular implementation). (rounded to the desired number of decimal places).

[0237] Temp local_DegK is the measured temperature (e.g., in degrees Kelvin or or other appropriate thermometric method),

[0238] Pv is the vapor pressure value generated by the vapor pressure function.

[0239] Such a generated flow estimation signal may be used, for example, for device diagnostics (e.g., fault detection). A controller (e.g., a central controller) or processor may be used to perform various operations for The estimated signal may be implemented by a processor (e.g., that of an RPT device). Alternatively, the evaluation of the flow signal generated by the flow sensor may be performed. In addition to evaluating the flow signals, the generated signals may be used for control and respiratory status detection. An example of the dynamic operation is described above in connection with FIG. 8A and illustrated in more detail in the example of FIG. 8C. This may be considered in relation to step or process 8008.

[0240] For example, in step or process 8030, the controller or processor Optionally, a measured flow signal may be received from a flow sensor 4274. In process 8031, the controller or processor receives the flow rate estimate signal 7008. may be received from the flow estimation process 7002. The controller or processor may evaluate the flow estimation signal 7008. For example, In some versions, such evaluation involves the use of any of the methods described herein. in conjunction with the analysis of flow signals from either the flow sensor or the flow sensor and instead of using a flow estimation signal. For example, the estimated signal may be a signal that is known to be used for the IPAP trigger, the EP Determining the start of patient exhalation for a cycle of AP, or a phase variable as described herein In some versions, the ventilator may be evaluated to determine the start of patient inspiration. Thus, the flow estimate signal may be evaluated in relation to the measured flow signal. The signal can be used as a diagnostic check on the measured flow signal. The processor may compare these two signals and, based on the comparison, generate an indicator ( For example, an indicator of an error, a failure, or no failure may be generated. In some versions, the difference or differences from different times along the signal (e.g. one or more If the threshold is significant (relative to the threshold above), the controller or processor generates a fault signal. If there is no fault difference, confirmation that there is no fault in the flow sensor is obtained. and the appropriate signal is, for example, an input signal to any of the methods or processes described above. The signal may be generated to enable operation dependent on the flow sensor.

[0241] Optionally, for example, changing the operation, stopping the operation, warning or alarming of an error (e.g. , audible, visual or communication type message) from process 8034. The output of the breathing device (e.g., a step or step signal) may be Some of these can be applied to control the RPT device in the process 8036. In such an example, such an output may be an indication or indication of an error, such as a flow sensor failure. For display of the relationship between the constant signal and the measured signal, the comparison may be reported on the diagnostic display. An example may be considered in conjunction with the graphs of Figures 9 and 10. As a further illustration, The RPT operating mode can be set to reduce dependency on the flow signal due to the indication of sensor failure. In some such controlled versions, such activities can be The RPT in the Normalized Flow Estimation operating mode uses the flow estimation signal (rather than the measured flow signal). In some such versions, the controller may process the pressure sensor signal. Ventilation control parameters (e.g., patient ventilation) for achieving control of the ventilation target for port adjustment As a further example, measurements of respiratory rate (e.g., tidal volume, minute ventilation) may be determined. The inhalation rate and respiratory flow can be determined from the estimated signal. The control parameters (e.g., pressure or flow control loops of the RPT controller) Either the flow rate estimation signal, the flow rate estimation signal, or both, may be modified based on the flow rate estimation signal. In one version, the detected difference between the estimated signal and the measured flow signal is For example, such a difference or error may be applied as an error signal for the calibration of It can be applied to adjust measurements from a flow sensor, thereby eliminating the need for calibration, adjustment, and measurement. The generated flow signal is fed to the control process of the RPT's controller, as described throughout this specification. Such a calibration process may be used during any of the following sessions: When activated before a treatment session, it can be used during the initialization process or both. This may be performed periodically by the device.

[0242] Other actions may also be performed by the controller processor using the flow estimate signal. Instead of the sensor signal and all other metrics or characteristics in other cases, the flow sensor signal is It will be appreciated that the input may be a conductance-based circuit breaker. The alarm may be implemented using such a flow estimate signal (rather than using a flow sensor signal). Thus, the conductance that serves as the basis for the detection of an open circuit condition can be measured. It may be calculated from the pressure signal and the estimated flow signal (eg, the ratio of the values ​​of such signals). Additionally, in some versions, the flow estimation signal is generated based on the flow rate of the flow estimator (e.g., a high flow therapy device). In an RPT configured as ) can be used together with the flow sensor. This can therefore serve as an alternative to providing a flow sensor ( That is, the flow sensor may be omitted) or in the event of a failure in the provided flow sensor. It can function as a backup in

[0243] The accuracy of such a flow rate estimation signal by the above method is shown in the graphs of Figs. 9 and 10. In FIG. 9A and FIG. 9B, the RPT Fan curves, which plot measured and estimated flow versus blower speed, are used to measure different FIG. 9A shows the device operating at an altitude of 2000 meters. FIG. 9B shows data for a device operating at an altitude of 3000 meters. As shown, the estimated flow curve is closer to the measured flow curve (the RPT blower flow). The approximation is very close (over the speed range of the fan curve).

[0244] A similar evaluation using RPT (using breather simulation) in service was performed. 10A and 10B, the RPT device Gas flow includes a breathing component (rather than a fan curve). These graphs are RPT measurements and flow estimates were compared during breathing-related maneuvers at different altitudes. The plots are of the device's fan speed at an altitude of 2000 meters. FIG. 10B shows data for a device operating at an altitude of 3000 meters. As shown, the estimated flow curves are Even when the chair fan adjusts in response to the simulated user's breathing effort, the flow Closely approximates the measured value.

[0245] 5.9 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.

[0246] 5.9.1 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.

[0247] Atmosphere: In certain aspects of the present technology, the term "atmosphere" refers to (i) the temperature of the treatment system or external to the patient, and (ii) the air in the treatment system or the patient or RPT device. It should be taken to mean immediately surrounding the outside of the pressure path.

[0248] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier. (e.g. the humidity inside the room where the patient sleeps). may differ from the humidity outside the room where you are sleeping.

[0249] In another example, the atmospheric pressure may be the pressure immediately surrounding or external to the body.

[0250] In certain embodiments, the ambient (e.g., acoustic) noise may be generated, for example, by an RPT device. Noise generated by the patient or generated by the mask or patient interface Ambient noise can be thought of as the background noise level in the room in which the sound is being heard. It can originate from any source.

[0251] Respiratory Pressure Therapy (RPT) air at therapeutic pressure, which is typically positive relative to the atmosphere Attachment to supply airway inlet.

[0252] Continuous Positive Airway Pressure (CPAP) Therapy: A method of therapy in which the therapeutic pressure remains fairly constant throughout the patient's respiratory cycle. In some forms of respiratory pressure therapy, the pressure at the entrance to the airways is increased during expiration. In some configurations, the pressure increases slightly during inspiration and decreases slightly during inspiration. Varies between different respiratory cycles (e.g., in response to detection of signs of partial upper airway obstruction) (It is increased in response to a partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0253] Patient: A person with or without respiratory disease.

[0254] Automatic positive airway pressure (APAP) therapy: Depending on the presence or absence of signs of SDB onset, e.g. For example, a C-type ventilator can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths. PAP therapy.

[0255] 5.9.2 Breathing cycle aspects Apnea: According to some definitions, an apnea is a period in which flow drops below a given threshold, e.g. An obstructive apnea is said to have occurred if it continues for a duration of 0 seconds. It occurs when some sort of airway obstruction does not allow air to flow despite the person's efforts. Open apnea is when the airway is open but there is no effort to breathe. It is said to refer to a condition in which apnea is detected due to a decrease or absence of respiratory effort. Breathlessness is said to refer to a state in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0256] Respiratory Rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0257] Duty cycle, or inspiratory fraction: the inspiratory time, Ti, relative to the total breathing time, Ttot The ratio.

[0258] Effort (breathing): Respiratory effort is the movement made by a person trying to breathe spontaneously. It is said to refer to.

[0259] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0260] Flow limitation: Flow limitation occurs when increased exertion by the patient does not cause a corresponding increase in flow. This is interpreted as a condition in the patient's breathing that is flow-limited during the inspiratory portion of the respiratory cycle. occurs, the flow limitation can be described as inspiratory flow limitation. When flow limitation occurs in the expiratory flow area, the flow limitation can be called expiratory flow limitation. do.

[0261] Types of flow-limited inspiratory waveforms: (i) (classical) plateau: a rise followed by a relatively flat area and then a decline To be continued. (ii) M-shaped: Two local peaks, one in the early part and one in the late part, Then there is a relatively flat area between the two peaks. (iii) Chair shape: A single local peak is present in the early part, followed by A relatively flat section follows. (iv) Inverted chair shape: A relatively flat area followed by a single local peak, the peak being It is provided at the rear.

[0262] Hypopnea: refers to a reduction in flow, not an interruption of flow. In one form, the threshold rate is When the below flow reduction continues for a sustained period of time, hypopnea is said to occur. If hypopnea is detected due to a decrease in inspiratory effort, central hypopnea is said to have occurred. do.

[0263] Hyperventilation: An increase in flow to a level higher than normal.

[0264] Hypoventilation: Hypoventilation occurs when the amount of gas exchange that occurs over a certain time scale is reduced It is said to occur when the supply of electricity falls short of the required level.

[0265] Hyperventilation: Hyperventilation occurs when the amount of gas exchange that occurs over a given time scale increases It is said to occur when demand exceeds demand.

[0266] Inhalation portion of the respiratory cycle: The period from the start of the inhalation flow to the start of the exhalation flow is called the respiratory cycle. It is taken as the intake part of the culvert.

[0267] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency and is an opening. Quantification of airway patency can be done, for example, by dividing the airway patency into two categories: patency (1) and closure (obstruction). ) can be used.

[0268] Positive End-Expiratory Pressure (PEEP): The pressure above the atmosphere in the lungs that exists at the end of expiration. There is.

[0269] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0270] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): these synonyms are may be understood to refer to an estimate of the respiratory airflow of the RPT device, typically in liters / "True respiratory flow" or "true respiratory airflow" is the actual respiratory flow of the patient expressed in minutes Used in contrast.

[0271] Tidal volume (Vt) The amount of air that is inhaled or exhaled without extra effort during normal breathing Volume of air. This volume is more specifically called the inhaled tidal volume (Vi) or the exhaled tidal volume ( Ve).

[0272] Inspiratory Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0273] Expiratory Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0274] Total (breath) time (Ttot): The time between the start of the inspiratory portion of one respiratory flow waveform and the start of the next respiratory flow The total duration between the start of the inspiratory portion of the waveform.

[0275] 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).

[0276] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. As the pressure difference in the upper airway increases (Starling resistor behavior), the flow rate increases slightly. The present invention may be associated with a condition of flow limitation that may increase or decrease.

[0277] Vent: A measure of the total amount of gas exchange carried out by a patient's respiratory system. Measurements may include either or both of inhalation and exhalation flows per unit of time. When expressed as a volume of air per minute, this amount is often called "minute ventilation." , sometimes simply given as volume, understood as volume per minute.

[0278] 5.9.3 RPT Device Parameters Flow Rate: The instantaneous volume (or mass) of air delivered per unit time. Flow Rate and Ventilation Rate have the same order of magnitude of volume or mass per unit time, but the flow rate is much shorter. In some cases, when referring to flow rate, it is a scalar quantity (i.e., In other cases, when referring to flow rate, the vector Refers to a quantity (i.e., a quantity that has both magnitude and direction). Also referred to as a signed quantity. In this case, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle, so that The flow rate is given the sign Q. The total flow rate Qt is the total amount of flow that leaves the RPT device. The ventilation flow Qv is the amount of air that must be ventilated to allow the exhaled gas to flow out. The leakage flow rate Ql is the flow rate of air exiting the patient interface system. The respiratory flow Qr is the flow rate of air received into the patient's respiratory system. .

[0279] Leakage: The term "leakage" is taken to mean an unintended air flow. Leaks can occur due to an imperfect seal between the mask and the patient's face. In another example, a leak may occur at the swivel elbow relative to the perimeter.

[0280] Pressure: force per unit area. Pressure can be measured in a variety of units (e.g., cmH 2 O (centimetres of water), gf / cm 2 , and hectopascals (hPa). H 2 O is 1g-f / cm 2 which is approximately 0.98 hPa. , unless otherwise stated, pressures are in cmH 2 It is given in units of O. The pressure is given the symbol Pm, which represents the target value that the mask pressure Pm should achieve at the current time. Therapeutic pressure is given the symbol Pt.

[0281] 5.9.4 Ventilator Terminology Backup rate: A ventilator parameter (triggered by spontaneous breathing efforts) The minimum respiratory rate (typically per minute) that can be delivered to a patient from a ventilator if no Establish a normal respiratory rate.

[0282] Cycling: The end of the inspiratory phase of the ventilator. The act of cycling from the ventilator to a spontaneously breathing patient. When delivering a breath, at the end of the inspiratory portion of the breathing cycle, the ventilator It is said to be cycled to stop inhalation delivery.

[0283] Expiratory Positive Airway Pressure (EPAP): The desired maximum pressure that the ventilator is trying to achieve at a given time. Base pressure to which varying pressures within a breath are added to generate mask pressure.

[0284] End expiratory pressure (EEP): The pressure that the ventilator attempts to achieve at the end of the expiratory portion of a breath. The desired mask pressure is the pressure waveform template Π(Φ) with a value of zero at the end of expiration. (i.e., if Π(Φ)=0 when Φ=1), then EEP is equal to EPAP.

[0285] Inspiratory positive airway pressure (IPAP): The maximum pressure that the ventilator attempts to achieve during the inspiratory portion of the breath. of desired mask pressure.

[0286] Pressure Support: A number indicating the increase in pressure during ventilator inhalation compared to the ventilator exhalation and mainly refers to the pressure difference between the maximum pressure during inspiration and the base pressure (e.g., PS = In some contexts, pressure support means (when the ventilator is actually This refers to the difference the ventilator tries to achieve (rather than the difference it achieves).

[0287] Servo ventilator: A ventilator that has both patient ventilation and target ventilation, and Adjust the level of pressure support to approach target ventilation.

[0288] Spontaneous / Timed (S / T): Attempts to detect the onset of breathing in spontaneously breathing patients , a mode of a ventilator or other device, but the device does not detect a breath for a period of time. If not, the device will automatically begin breath delivery.

[0289] Swing: A term equivalent to pressure assistance.

[0290] Triggering: When a ventilator delivers a breath of air to a spontaneously breathing patient, the patient triggering the ventilator to deliver a breath when the patient begins the breath portion of the breathing cycle. He says that it was.

[0291] Ventilator: A mechanical device that provides pressure support to a patient while performing some or all of the work of breathing. Vice.

[0292] 5.9.5 Respiratory System Anatomy diaphragm sheet of muscle that runs over the lower rib cage. It protects the heart, lungs, and ribs It separates the thoracic cavity, which contains the lungs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases, allowing air to enter the lungs. It draws you in.

[0293] Larynx: The larynx or voice box that contains the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea. Continue.

[0294] Lung: respiratory organ in humans. The conductive zones of the lungs are the trachea, bronchi, bronchioles, and terminalis. The respiratory zone includes the respiratory bronchi, the alveolar ducts and the alveoli.

[0295] Nasal Cavity: The nasal cavity (or nasal fossa) is a large, air-filled cavity in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides are the nasal conchae (singular "concha") or nasal There are three horizontal extensions called nasal bones. The nasal cavity is divided into two parts, the nose at the front and the choanerus at the back. It then connects to the nasopharynx.

[0296] pharynx throat located directly below (inferior to) the nasal cavity and above the esophagus and larynx The pharynx has traditionally been divided into the nasopharynx (upper pharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the pharynx It is divided into three parts: the pharynx (the mouth part of the throat), and the hypopharynx. 5.10 Other Notes

[0297] 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.

[0298] 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.

[0299] Furthermore, when a value or values ​​are embodied herein as part of the technology, 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.

[0300] Unless otherwise stated, all technical and scientific terms used herein belong to the art. The term has the same meaning as commonly understood by those skilled in the art. and any methods and materials similar or equivalent to the materials used in the practice or testing of this technology. Although a limited number of exemplary methods and materials can be used in the present invention, It will be described.

[0301] 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.

[0302] As used herein and in the appended claims, the singular form "a" "an" and "the" are used interchangeably unless the context clearly indicates otherwise. Please note that the present invention includes multiple equivalents of:

[0303] All publications mentioned herein are incorporated by reference in their entirety for all purposes, including, but not limited to, the disclosures of the methods and materials that are the subject of such publications. The disclosures and descriptions are incorporated by reference. The publications mentioned herein are incorporated by reference in their entirety. The present invention is provided solely for its disclosure prior to the filing date. Nothing herein shall be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior patent. In addition, the publication dates listed may differ from the actual publication dates. may require separate verification.

[0304] The words "comprises" and "comprising" mean elements, constituent parts, The elements or steps described herein should be construed as referring to each element or step in a non-exclusive manner. An element, component or step is not specifically referred to as another element, component or step. Indicates that they can exist, be used or be combined together.

[0305] 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.

[0306] The technology herein has been described with reference to specific embodiments, but these embodiments It should be understood that these are merely illustrative of the principles and applications of the present technology. In some instances, 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" (etc.) are used, unless otherwise specified. These terms are not intended to denote any order but are used to distinguish between separate elements. In addition, the process steps in the method are described or illustrated in order. Although the present invention may be described in order, such order is not required. The order of the operations can be changed and the operations can be performed simultaneously or even synchronously. Recognize that:

[0307] Thus, numerous exemplary embodiments may be implemented without departing from the spirit and scope of the present technology. It should be understood that variations of the above are possible and other arrangements may be devised. . [Explanation of symbols]

[0308] 5.11 List of References Patients:1000 Patient Interface: 3000 Non-invasive patient interfaces: 3000 Seal forming structure: 3100 Plenum chamber: 3200 Structure: 3300 Ventilation section: 3400 Connection port: 3600 Frontal support: 3700 RPT devices: 4000 External housing: 4010 Top: 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 Controllable blower: 4142 Motor: 4144 Air circuit: 4170 Supplemental oxygen: 4180 Electrical parts: 4200 Printed Circuit Board Assembly: 4202 Power: 4210 Input device: 4220 Central controller: 4230 Clock: 4232 Treatment Device Controller: 4240 Protection circuit: 4250 Memory: 4260 Converter: 4270 Pressure sensor: 4272 Flow sensor: 4274 Gas temperature sensor: 4275 Motor speed converter: 4276 Ambient pressure sensor: 4277 Ambient Relative Humidity Sensor: 4279 Data communication interface: 4280 Remote external communication network: 4282 Local external communication network: 4284 Remote external devices: 4286 Local external devices: 4288 Output device: 4290 Display driver: 4292 Display: 4294 Algorithm: 4300 Pre-processing module: 4310 Pressure compensation algorithm: 4312 Estimated air flow rate: 4314 Leakage flow rate estimation algorithm: 4316 Flow signal estimation: 4317 Respiratory flow estimation algorithm: 4318 Treatment engine module: 4320 Phase Determination Algorithm: 4321 Waveform determination algorithm: 4322 Ventilation decision algorithm: 4323 Intake flow restriction detection: 4324 Apnea detection algorithm: 4325 M-shape detection algorithm: 4326 Airway Patency Determination Algorithm: 4327 Typical Recent Ventilation Decisions: 4328 Treatment parameter determination algorithm: 4329 Treatment control module: 4330 Humidifier:5000 Humidifier inlet: 5002 Humidifier outlet: 5004 Humidifier base: 5006 Humidifier Reservoir: 5110 Humidifier Reservoir Dock: 5130 Heating element: 5240 Humidifier controller: 5250 Estimated process: 7002 Flow Estimation Unit: 7004 Flow rate estimation signal: 7008 Input signal: 7010 Pressure: 7012 Motor speed: 7014 Ambient pressure: 7016 Gas temperature: 7018 Ambient relative humidity: 7020 Motor parameters: 7021 Oxygen sensor signal: 7023 Step or Process: 8002-34

Claims

1. a signal indicative of an estimate of a flow rate of a flow of breathable gas associated with the respiratory treatment device; 13. A method of a controller for generating a respiratory treatment device, the respiratory treatment device comprising: Including, An electronic signal indicative of a measurement of the pressure of the breathable gas is transmitted from the pressure sensor to the controller. receiving the The controller receives an electronic signal from a speed sensor indicative of a measurement of the speed of the motor. And, said controller calculating an entrained air density function; A signal indicative of an estimate of the flow rate of breathable gas is sent to the controller using a flow estimation function. wherein the flow estimation function is generated by a signal indicative of a measurement of the pressure. (b) a signal indicative of a measurement of the speed of the motor; and (c) a function of the entrained air density function. Including the number, The method includes:

2. The method of claim 1 , wherein the entrained air density function includes an air density value and an air density reference value. method.

3. The entrained air density function includes a first ratio of the air density value and the air density reference value. The method of claim 2 .

4. The entrained air density function includes a second ratio of the air density value and the air density reference value. The method of claim 3 .

5. estimating the flow of breathable gas further comprises calculating a motor force; The determined estimate of the flow rate of breathable gas is based on the motor force, claims 1 to 4.

2. The method according to claim 1 .

6. The entrained air density function includes a function of an ambient pressure value, a temperature value, and a relative humidity value. Item 6. The method according to any one of items 1 to 5.

7. and evaluating a signal from an oxygen sensor to calculate the entrained air density function. The method according to claim 6.

8. an electronic signal indicative of a measurement of the ambient pressure of the breathable gas from the ambient pressure sensor; a controller receiving said ambient pressure value; is a measurement of the ambient pressure, An electronic signal indicative of a measurement of the gas temperature of the breathable gas is transmitted from the gas temperature sensor to the computer. a gas temperature controller receiving said temperature value of said breathable gas; is a measurement of the degree an electronic signal indicative of a measurement of the ambient relative humidity of said breathable gas from an ambient relative humidity sensor; wherein the controller receives the relative humidity value of the ambient air; is a measure of the ambient relative humidity of the gas, The method of claim 6 further comprising:

9. The function of the atmospheric pressure value, the temperature value, and the relative humidity value is a saturated steam The method of any one of claims 6 to 8, comprising a pressure function.

10. The saturated steam pressure function according to the temperature is [0010] It is stipulated by Temp ｌｏｃａｌ＿ＤｅｇＣ The method of claim 9 , wherein: is the temperature value.

11. The function of the atmospheric pressure value, the temperature value, and the relative humidity value is The method according to any one of claims 6 to 10, comprising a steam pressure function according to

12. The vapor pressure function according to temperature and relative humidity is: (a) the saturated vapor pressure according to temperature (b) the result of the force function; and (b) the relative humidity value. [0025] It is defined by multiplying R.H. ｌｏｃａｌ is the relative humidity value, Psv (Temp ｌｏｃａｌ＿ＤｅｇＣ ) is the saturated steam pressure function according to the temperature. The method according to claim 11 when dependent on any one of claims 9 to 10, 。

13. The function of the ambient pressure value, the temperature value, and the relative humidity value is [0030] It is stipulated by P ０ = 103 hectopascals, T ０ = 15 degrees Celsius or 288.15 degrees Kelvin, [0045] and P ａｔｍ＿ｌｏｃａｌ is the atmospheric pressure value, [0050] is the vapor pressure function as a function of temperature and relative humidity, Temp ｌｏｃａｌ＿ＤｅｇＫ The method of claim 12 , wherein: is the temperature value.

14. The flow estimation function according to any one of claims 1 to 13, wherein the flow estimation function comprises a set of frequency functions. How to.

15. The set of frequency functions includes a first rotational frequency function, the first rotational frequency function being 15. The method of claim 14, wherein the motor speed measurement is a function of the entrained air density function. Method of posting.

16. The set of frequency functions includes a second rotational frequency function, the second rotational frequency function being 16. The method of claim 15, wherein the motor speed is a function of the measured speed of the motor.

17. The set of frequency functions includes a third rotational frequency function, the third rotational frequency function being 17. The method of claim 16, wherein the motor speed measurement is a function of the entrained air density function. method.

18. The first rotational frequency function is [006] It is stipulated by RPM is a measure of the speed of the motor; [0070] is the entrained air density function, 20. The method of claim 17, wherein C1 and C2 are empirically derived constants.

19. The second rotational frequency function is [0080] It is stipulated by RPM is a measure of the speed of the motor; Any of claims 17 to 18, wherein C3, C4 and C5 are empirically derived constants.

3. The method according to claim 1 .

20. The third rotational frequency function is [0097] It is stipulated by RPM is a measure of the speed of the motor; [0010] is the entrained air density function, Any of claims 17 to 19, wherein C6, C7 and C8 are empirically derived constants.

3. The method according to claim 1 .

21. The flow estimation function is ##EQU00011## It is stipulated by A is the first rotational frequency function; B is the second rotational frequency function; C is the third rotational frequency function; Pres_meas is the measurement of the pressure of the breathable gas from the pressure sensor; The method of claim 20 .

22. An electronic signal indicative of a measurement of the flow rate of the breathable gas is transmitted from the flow sensor to the controller. receiving the The electronic signal indicating a measure of the flow rate of the breathable gas and the a generated signal indicative of the estimated value; The controller includes a controller unit configured to control the flow rate of the flow sensor and a controller that controls the flow rate of the flow sensor. The roller generates The method of any one of claims 1 to 21, further comprising:

23. A control parameter for operating the motor-operated blower is input to the output indicator. The method of claim 22 , further comprising the controller modifying based on:

24. The motor-operated The controller further includes modifying a control parameter to operate the blower. The method of claim 22 .

25. The control parameter is one of a pressure set point and a flow rate set point.

25. The method of any one of claims 23 and 24, wherein

26. A processor-readable medium having processor-executable instructions stored thereon, comprising: The processor executable instructions include a program for programming a motor-operated blower in a respiratory treatment device. When executed by the controller of the processor, a respiratory treatment device associated with the respiratory treatment device is generating an estimate of the flow rate of breathable gas; The instructions include instructions for controlling operation according to the method of any one of claims 1 to 25. A processor-readable medium.

27. 1. A respiratory treatment device comprising: a patient respiratory interface adapted to couple to the patient respiratory interface and including a flow of breathable gas; a motor-operated type adapted to generate respiratory therapy through the patient respiratory interface; A blower and a pressure sensor configured to generate an electronic signal indicative of a measurement of the pressure of the breathable gas; With Nsa, a speed sensor configured to generate an electronic signal indicative of a measurement of the speed of the motor; one or more processors, the motor-operated blower, the pressure sensor and the A controller coupled to the speed sensor; Including, The controller: receiving an electronic signal indicative of a measurement of the pressure of the breathable gas; receiving the electronic signal indicative of a measurement of the speed of the motor; Calculating an entrained air density function; generating a signal indicative of an estimate of the flow rate of said breathable gas using a flow estimation function; wherein the flow estimation function comprises: (1) a signal indicative of a measurement of the pressure; (b) a signal indicative of the speed of the motor; and (c) a signal indicative of a measurement of the entrained air density function. A respiratory treatment device configured to:

28. 28. The method of claim 27, wherein the entrained air density function includes an air density value and an air density reference value. Respiratory care devices.

29. The entrained air density function includes a first ratio of the air density value and the air density reference value.

30. The respiratory treatment device of claim 28.

30. The entrained air density function includes a second ratio of the air density value and the air density reference value.

30. The respiratory treatment device of claim 29.

31. To determine the estimate of the flow rate of breathable gas, the controller may include one or more and calculating a motor force from the sensor signal of the flow of breathable gas. The method according to any one of claims 27 to 30, wherein the determined estimate of the quantity is based on the motor force. Respiratory therapy devices.

32. The entrained air density function includes a function of an ambient pressure value, a temperature value, and a relative humidity value. A respiratory treatment device according to any one of claims 27 to 31.

33. The controller evaluates a signal from an oxygen sensor to calculate the entrained air density function.

33. The respiratory treatment device of claim 32, further configured to:

34. configured to generate an electronic signal indicative of a measure of the ambient pressure of the breathable gas; the ambient pressure value being a measurement of the ambient pressure of the breathable gas; and, configured to generate an electronic signal indicative of a measurement of a gas temperature of the breathable gas; a gas temperature sensor, the gas temperature value being a measurement of the gas temperature of the breathable gas; configured to generate an electronic signal indicative of a measurement of the ambient relative humidity of the breathable gas; an ambient relative humidity sensor, the ambient relative humidity value being a measurement of the ambient relative humidity of the breathable gas; Sa, and Further comprising: The controller: the electronic signal indicative of a measurement of the atmospheric pressure; said electronic signal indicative of a measurement of gas temperature; said electronic signal indicative of a measurement of ambient relative humidity; A respiratory treatment device according to any one of claims 32 to 33, configured to receive Chair.

35. The function of the atmospheric pressure value, the temperature value, and the relative humidity value is a saturated steam A respiratory treatment device according to any one of claims 32 to 34, comprising a pressure function.

36. The saturated steam pressure function according to the temperature is ##EQU00012## It is stipulated by Temp ｌｏｃａｌ＿ＤｅｇＣ 36. The respiratory treatment device of claim 35, wherein Vice.

37. The function of the atmospheric pressure value, the temperature value, and the relative humidity value is A respiratory treatment device according to any one of claims 27 to 36, comprising a vapour pressure function according to 。

38. The vapor pressure function according to temperature and relative humidity is: (a) the saturated vapor pressure according to temperature (b) the result of the force function; and (b) the relative humidity value. ##EQU00013## It is defined by multiplying R.H. ｌｏｃａｌ is the relative humidity value, Psv (Temp ｌｏｃａｌ＿ＤｅｇＣ ) is the saturated steam pressure function according to the temperature. The respiratory treatment method according to claim 35 when dependent on any one of claims 7 to 8. Medical devices.

39. The function of the ambient pressure value, the temperature value, and the relative humidity value is ##EQU14## It is stipulated by P ０ = 103 hectopascals, T ０ = 15 degrees Celsius or 288.15 degrees Kelvin, ##EQU00015## and P ａｔｍ＿ｌｏｃａｌ is the atmospheric pressure value, ##EQU00016## is the vapor pressure function as a function of temperature and relative humidity, Temp ｌｏｃａｌ＿ＤｅｇＫ 40. The respiratory treatment device of claim 38, wherein Vice.

40. A method according to any one of claims 27 to 39, wherein the flow estimation function comprises a set of frequency functions. Respiratory therapy devices.

41. The set of frequency functions includes a first rotational frequency function, the first rotational frequency function being 41. The method of claim 40, wherein the motor speed measurement is a function of the entrained air density function. Inhalation therapy device.

42. The set of frequency functions includes a second rotational frequency function, the second rotational frequency function being 42. The respiratory treatment device of claim 41, wherein the motor speed is a function of the measured speed of the motor.

43. The set of frequency functions includes a third rotational frequency function, the third rotational frequency function being 43. The method of claim 42, wherein the motor speed measurement is a function of the entrained air density function. Inhalation therapy device.

44. The first rotational frequency function is ##EQU00017## It is stipulated by RPM is a measure of the speed of the motor; [0018] is the entrained air density function, 44. The respiratory treatment device of claim 43, wherein C1 and C2 are empirically derived constants. Chair.

45. The second rotational frequency function is [0019] It is stipulated by RPM is a measure of the speed of the motor; Any of claims 43 to 44, wherein C3, C4 and C5 are empirically derived constants.

2. A respiratory treatment device as described in claim 1.

46. The third rotational frequency function is [0020] It is stipulated by RPM is a measure of the speed of the motor; ##EQU00021## is the entrained air density function, Any of claims 43 to 45, wherein C6, C7 and C8 are empirically derived constants.

2. A respiratory treatment device as described in claim 1.

47. The flow estimation function is [0022] It is stipulated by A is the first rotational frequency function; B is the second rotational frequency function; C is the third rotational frequency function; Pres_meas is the measurement of the pressure of the breathable gas from the pressure sensor; 47. The respiratory treatment device of claim 46.

48. a flow sensor configured to generate an electronic signal indicative of a measure of the flow rate of the breathable gas; It further contains The controller: receiving the electronic signal indicative of a measurement of the flow rate of breathable gas; the electronic signal indicating a measurement of the flow rate of the breathable gas; and comparing the generated signal indicative of an estimate of generating an output indicator indicative of an assessment of accuracy of the flow sensor based on the comparison. Toto The respiratory treatment device of any one of claims 27 to 47, further configured to: Vice.

49. The controller operates the motor-operated blower based on the output indicator.

49. The method of claim 48, further configured to modify a control parameter for moving the Respiratory care devices.

50. The controller determines based on the generated signal indicative of the estimate of the breathable gas. and further comprising: modifying a control parameter to operate the motor-operated blower in accordance with the 49. The respiratory treatment device of claim 48 configured

51. The control parameter is one of a pressure set point and a flow rate set point.

51. The respiratory treatment device of any one of claims 49 and 50,

52. further comprising a processor-readable medium having processor-executable instructions stored thereon; The processor executable instructions may include instructions for controlling one or more of the motor-operated blower controllers. When executed by the processor, the estimate of the flow rate of breathable gas is calculated based on the one or more The processor-executable instructions are generated by the processor according to any one of claims 1 to 25.

52. A method according to any one of claims 27 to 51, comprising instructions for controlling operation according to the method of any one of claims 27 to 51. Item 11. A respiratory treatment device as described in item 10.

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