Apparatus and operation methods for treatment of respiratory disorders

Abstract

To provide methods, apparatus, and systems for treating a respiratory disorder in a patient.SOLUTION: The apparatus comprises: a pressure generator configured to generate a flow of air so as to provide ventilatory support to the patient; a transducer configured to generate a flow signal representing a property of the flow of air; and a controller. The controller is configured to: analyze the flow signal to estimate the inspiratory volume and the expiratory volume of a breath of the patient; and servo-control the degree of ventilatory support to adjust an estimated tidal volume toward a target tidal volume. A gain of the servo-control is dependent on a difference between the estimated inspiratory volume and the estimated expiratory volume. The method comprises operating an apparatus or system in a similar manner.SELECTED DRAWING: Figure 9

Description

[Technical field]

[0001] 1 CROSS-REFERENCE TO RELATED APPLICATIONS This application is incorporated by reference in its entirety. No. 6,233,336, filed on Oct. 13, 2001, the disclosure of which claims the benefit of US Pat. No. 6,233,336, the contents of which are incorporated herein by reference. 2. Technology Background 2.1 Technology field

[0002] This technology is intended to screen, diagnose, monitor, treat, prevent and ameliorate respiratory-related diseases. The present technology also relates to medical devices or apparatus and their operation and use. do. [Background technology]

[0003] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases

[0004] The body's respiratory system facilitates gas exchange. The nose and oral cavity form the entrance to a patient's airways. do.

[0005] 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 further divide into terminal bronchioles. The bronchi are the conducting airways. They constitute the respiratory tract and do not participate in gas exchange. The alveolar region of the lungs is where gas exchange occurs and is called the alveolar cavity. This is called the breathing zone. See: Respiratory Physiolo gy”, by John B. West, Lippincott William S & Wilkins, 9th edition published 2012.

[0006] A range of respiratory diseases exists. Certain diseases are associated with specific episodes (e.g., apnea, respiratory It may be characterized by hypopnea and hyperpnea.

[0007] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CS) and R), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular This includes non-metastatic disease (NMD) and chest wall disease.

[0008] 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 abnormally small breathing problems during sleep. Normal defects in muscle tone in the upper airway and tongue region, combined with the soft palate and posterior oropharyngeal wall This condition typically causes respiratory arrest in affected individuals for 30 to 120 minutes. This causes breathing to stop for up to 200 to 300 seconds each night, resulting in daytime sleepiness. This can lead to excessive blood flow and cardiovascular disease and brain damage. This condition is common. It is common in middle-aged, overweight men, but patients do not experience any symptoms. See Sullivan at 310.

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. It is a disorder of the respiratory regulator in people with chronic respiratory distress syndrome, characterized by alternating waxing and waning of ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CCR can be severe. It is accompanied by recurrent sleep-wake episodes that cause insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones). .

[0010] Respiratory failure is a general term for respiratory disorders that result in the inability to inhale or expel sufficient oxygen to meet the patient's needs. Respiratory failure refers to the inability of the lungs to expel sufficient CO2. It may include some or all of the above.

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

[0012] Obesity hypoventilation syndrome (OHS) is a condition characterized by severe obesity and arousal in the absence of other known causes of hypoventilation. It is defined as a combination of chronic hypercapnia and shortness of breath. Symptoms include shortness of breath, headaches on awakening, and These include pain and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) is a group of lower respiratory tract diseases that share certain common characteristics. This includes any of the following: increased resistance to air movement, prolonged expiratory phase of breathing and a decrease in the normal elasticity of the lungs. Examples of COPD include emphysema and chronic obstructive pulmonary disease. The causes of COPD include chronic smoking (the primary risk factor), occupational exposure, and air pollution. Pollution and genetic factors are the causes. Symptoms include dyspnea on exertion, chronic cough and sputum production. be.

[0014] Neuromuscular diseases (NMDs) affect muscle tissue either directly through intrinsic muscle pathology or indirectly through neuropathology. It is a broad term that encompasses many diseases and disorders that impair function. Some people with NMD: Some are characterized by progressive muscle damage resulting in inability to walk and being wheelchair bound. This can lead to bloating, difficulty swallowing, and respiratory muscle weakness, ultimately resulting in death from respiratory failure. Meat disorders can be classified as rapidly progressive and slowly progressive as follows: (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 dystrophy in teenagers (ii) variable or slowly progressive disorder: muscle disorder that worsens over several years; Characterized by only minor reductions in life expectancy (e.g., limb girdle, face-scapular Brachial and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: :Increasing general weakness, dysphagia, dyspnea on exertion and at rest, fatigue, drowsiness, morning headache , and difficulty concentrating and mood changes.

[0015] 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. Share the potential for respiratory insufficiency. Scoliosis and / or kyphoscoliosis can lead to severe respiratory insufficiency. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema. , orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite .

[0016] A range of treatments are available to treat or ameliorate such conditions. Otherwise healthy people can also benefit from preventive treatment of respiratory diseases. However, these have several deficiencies. 2.2.2 Treatment

[0017] Various therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV) and and invasive ventilation (IV) are used to treat one or more of the above respiratory conditions.

[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is, for example, to push the soft palate and tongue forward toward the posterior oropharyngeal wall. By moving the device back or forward, the continuous positive airway pressure acts as a pneumatic splint, This may prevent upper airway closure. Treatment of OSA with CPAP therapy may be voluntary. To this end, such patients must meet one or more of the following criteria for the device used to deliver treatment: Patients may choose not to adhere to treatment if they notice: discomfort, difficulty in use , expensive, and aesthetically unappealing.

[0019] Noninvasive ventilation (NIV) is the provision of ventilatory support to a patient through the upper airway to partially relieve respiratory function. or overall to help the patient breathe and / or maintain adequate oxygen levels in the body. Ventilatory support is provided via a non-invasive patient interface. IV is used to treat CSR and respiratory failure in the form of OHS, COPD, NMD, and chest wall disorders. It is used to treat.

[0020] Invasive ventilation (IV) is the provision of assisted ventilation to patients who can no longer breathe effectively on their own. Assistance may be provided using a tracheotomy tube.

[0021] In some forms, the comfort and effectiveness of these treatments may be improved. 2.2.3 Treatment system

[0022] These therapies may be provided by a therapeutic system or device. The systems and devices are intended to screen, diagnose, or monitor disease without treating it. It can also be used for this purpose.

[0023] The therapy system consists of a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, and a patient inlet. It may include a data interface, and data management. 2.2.3.1 Respiratory Pressure Therapy (RPT) Devices

[0024] Respiratory pressure therapy (RPT) devices, for example, actuate the device to provide an interface to the airway. By generating an air delivery flow to the source, one or more of the above-mentioned therapies can be delivered. This air flow may be pressurized. RPT devices typically consist of a pressure generator (e.g., a motorized blower or compressed gas reservoir). and configured to deliver a flow of air to the patient's airway. Flow can be delivered at positive pressure to the patient's airway. The outlet of the RPT device is connected to the air circuit via It is connected to a patient interface as follows:

[0025] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System. Another example of an RPT device is the ResMed PT System (manufactured by ResMed Limited). , ventilators. ResMed Elisee® 150 ventilator and ResMed VSIII® Ventilator for Adult Patients for the Treatment of Multiple Conditions or provide suitable invasive and non-invasive dependent respiratory support for pediatric patients. These ventilators offer volume- and pressure-controlled ventilation modes with single or dual limb circuits. provide. 2.2.3.2 Patient Interface

[0026] The patient interface may, for example, provide airflow to the airway inlet to provide a respiratory The airflow may be directed through the nose and / or nose. or may be delivered via a mask into the mouth, a tube into the mouth, or a tracheostomy tube into the patient's trachea. Depending on the therapy being applied, the patient interface may be configured to form a seal with, for example, an area of ​​the patient's face. This allows for a sufficient amount of pressure dispersion along with atmospheric pressure for therapy to be performed. to facilitate gas delivery (e.g., at a positive pressure of about 10 cmH2O relative to atmospheric pressure). In other forms of therapy, such as oxygen delivery, the patient interface provides approximately 10 cmH may not contain a sufficient seal to facilitate delivery of gas to the airway at a positive pressure of 20°. be. 2.2.3.3 Humidifier

[0027] Airflow delivery without humidification can lead to drying of the airways. When used with a chair and patient interface, humidified gas is generated, which may cause irritation of the nasal mucosa. This minimizes drying of the airway and increases patient airway comfort. Additionally, in cooler climates Generally, the application of hot air to the facial area surrounding the patient interface provides greater comfort than cool air. Increased suitability. 2.2.3.4 Data Management

[0028] Patients prescribed respiratory treatment for clinical reasons are “compliant” ( For example, a patient may need to configure their RPT device to comply with one or more “compliance rules.” The CPAP treatment is a treatment that is administered by a physician or other medical professional. An example of a compliance rule is the requirement that a patient be considered compliant. The study was conducted to determine whether patients wore the RPT device overnight for at least 21 out of 30 consecutive days. should be administered for at least 4 hours. Determine patient compliance. To this end, RPT device providers (e.g., healthcare providers) must Data describing patient treatment with devices was obtained manually to measure utilization over time. and compare this to compliance rules. If you determine that you have used your RPT device in accordance with the compliance rules, A health care provider may notify a third party that a patient is in compliance. .

[0029] Patient care benefits from communication of treatment data to third parties or external systems Other variations are possible. 2.2.3.5 Ventilation technology

[0030] Some forms of treatment systems include a vent to push out exhaled carbon dioxide. This vent allows the patient interface to have sufficient internal space (e.g., plenum chamber) to be A gas flow may be possible from the patient interface (e.g., to the outside of the patient interface (e.g., to the surroundings). 3. Brief description of the technology

[0031] The technology may be used in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases. These medical devices provide improved comfort, cost and effectiveness. The present invention has one or more of the following characteristics: ease of use, manufacturability, and versatility.

[0032] A first aspect of the present technology is a method for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disease. This relates to devices used in defense.

[0033] Another aspect of the present technology is directed to the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders. This relates to the methods used in

[0034] One form of the present technology includes an apparatus for the treatment of respiratory disorders using a safe volume servo ventilation mode. The gain of the pressure support servo control is the difference between the estimated inspiratory volume and the estimated expiratory volume. Based on.

[0035] In accordance with one aspect of the present technology, there is provided an apparatus for treating respiratory disorder in a patient, the apparatus comprising: a pressure generator configured to generate an air flow to provide ventilatory support to a patient; A transducer configured to generate a signal indicative of a characteristic of the airflow, and a controller. The controller analyzes the signal to estimate the patient's inhaled and exhaled volumes. The degree of ventilatory support is adjusted to adjust the estimated tidal volume closer to the target tidal volume. and servo-controlling the estimated gain. The estimated inhaled volume depends on the difference between the estimated inhaled volume and the estimated exhaled volume.

[0036] In one example of this embodiment, the gain is an increase in the difference between the estimated inhalation volume and the estimated exhalation volume. In a further example, the gain is relative to the estimated tidal volume: The gain depends on the difference between the estimated inhalation volume and the estimated exhalation volume. The magnitude of the difference between the estimated inspired volume and the estimated expired volume depends on the absolute magnitude of the difference between the estimated inspired volume and the estimated expired volume.

[0037] In another example of this embodiment, the degree of ventilatory support is pressure support of the ventilatory support.

[0038] In accordance with a further aspect of the present technology, a device for generating airflow to provide ventilatory assistance to a patient is provided. A method of operating a respiratory treatment device configured as described above is provided, the method including: The characteristics of the air flow are measured using a transducer, and the measured characteristics are stored in the controller. and estimating the inhalation and exhalation volumes of the patient's breath by analyzing the estimated inhalation volume and the estimated exhalation volume. calculating a gain in the controller based on the difference between the determined exhalation volume and the determined exhalation volume; and servo-controlling the respiratory treatment device using the calculated gains by a controller. , adjusting the patient's estimated tidal volume to approach the target tidal volume.

[0039] In one embodiment of this aspect, the gain is a function of the estimated inspiratory volume relative to the estimated tidal volume. In another example, the gain depends on the difference between the estimated inspiratory volume and the estimated expiratory volume. In another example, the amount of ventilatory support depends on the absolute magnitude of the difference between the estimated expiratory volume and the estimated expiratory volume. The degree of ventilatory support is pressure support.

[0040] In accordance with a further aspect of the present technology, a system for treating respiratory disorders in a patient is provided. The system includes a means for generating airflow to provide ventilatory support to a patient, and a characteristic of the airflow. and analyzing the signal to estimate the inhaled and exhaled volumes of the patient's breath. and a means for adjusting the estimated tidal volume to approach a target tidal volume. and a means for servo-controlling the degree of assistance. The gain of the servo control is determined by the estimated intake volume and , depends on the difference between the estimated expired volume.

[0041] In accordance with a further aspect of the present technology, there is provided an apparatus for treating respiratory disorders in a patient. The apparatus includes a blower configured to deliver a supply of air to provide ventilatory support to a patient, and an air blower. The system includes a transducer configured to generate a signal indicative of a characteristic of the supply, and a controller. The controller analyzes the signal to estimate the patient's inhaled and exhaled volumes. The servo control gain is adjusted based on the difference between the estimated inhalation volume and the estimated exhalation volume. The method is configured to:

[0042] In one example of this aspect, the controller determines a time between the estimated inhalation volume and the estimated exhalation volume. The servo control gain is adjusted so that the gain decreases as the difference increases. As the servo control gain is adjusted, the rate at which the pressure assist of the air supply is adjusted decreases. In this case, the controller adjusts the servo control gain if the difference is 20% or more. or to deactivate the servo control gains when the difference falls back below 20%. The control unit is further configured to make an adjustment to the fault value.

[0043] The described methods, systems, devices and apparatus allow functionality (e.g. For example, a processor for a special purpose computer, a respiratory monitor and / or a respiratory treatment device Further, the methods, systems, and devices described herein may be implemented to improve the performance of the system. The systems and devices provide automated management, monitoring and / or treatment of respiratory conditions (e.g., sleep disordered breathing). This allows for improvements in the field of treatment.

[0044] Of course, some of the above aspects may form sub-aspects of the present technology. Various combinations of the various claims and / or examples can be used to provide further aspects of the present technology. Similar or subembodiments may also be constructed.

[0045] Other features of the present technology are included in the following detailed description, abstract, drawings, and claims. It becomes clear in light of the information. [Brief description of the drawings]

[0046] 4. Brief Description of the Drawings 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: , which contains the following similar elements: 4.1 Treatment system [Figure 1] 1 includes a system including a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 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] 4 shows an RPT device 4000 in accordance with one form of the present technology. [Figure 4B]FIG. 4 is a schematic diagram of an air circuit of an RPT device 4000 in accordance with one form of the present technology. Upstream and downstream directions are shown relative to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] FIG. 40 is a schematic diagram of electrical components of an RPT device 4000 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 6] Figure 6 shows a model of a typical human respiratory waveform during sleep. 4.7 Respiratory Pressure Treatment Modes [Figure 7A] FIG. 7A is a graph illustrating undesirable behavior of pressure support during a sudden leak change in conventional safe volume mode. [Figure 7B] FIG. 7B is a graph showing pressure assist behavior during a sudden leak change in safe volume mode in accordance with one form of the present technology. [Figure 8] FIG. 8 is a graph illustrating the adjustment of servo control gain in safe volume mode as a function of the relative difference between inspired and expired volumes. [Figure 9] FIG. 9 is a flow chart outlining a method for adjusting servo controller gains in a respiratory device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in more detail, it will be appreciated that the present technology may be used in a variety of different ways as described herein. It should be understood that the invention is not limited to the specific examples described herein. 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.

[0048] The following description refers to various embodiments that may share one or more common characteristics and / or features. One or more features of any one embodiment may be used in conjunction with other embodiments or other implementations. It should be understood that it is possible to combine one or more features of the examples. Any single feature or combination of features in any of these embodiments may be used. may constitute a further embodiment. 5.1 Treatment

[0049] In one form, the present technology includes a method of treating a respiratory disorder. The step includes applying positive pressure to the entrance of the passageway.

[0050] In certain embodiments of the present technology, a supply of air at positive pressure is delivered through one or both nostrils. It is delivered to the patient's nasal passages.

[0051] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented. . 5.2 Treatment system

[0052] In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. or a device that delivers pressurized air to a patient interface 3000, as shown, for example, in FIG. The RPT device 4000 may include an RPT circuit 4170 that supplies the . 5.3 Patient Interface

[0053] A non-invasive patient interface 3000 according to one aspect of the present technology may be, for example, as shown in FIG. The seal-forming structure 3100, the plenum chamber 3200, the position The fixing and stabilizing structure 3300, the vent 3400, and the air circuit 4170 are connected to each other. 3600, and a forehead support 3700. In some embodiments, Aspects may be provided by one or more physical components. Thus, one physical component may provide one or more functional aspects. The seal-forming structure 3100 is adapted to contact the airway of the patient to facilitate the supply of air at positive pressure to the airway. is arranged to surround the entrance of the 5.4 RPT Devices

[0054] The RPT device 4000 according to one aspect of the present technology may be mechanical, pneumatic, and / or electrical. 4300, which may include one or more algorithms 4300 (e.g., the algorithms described herein, in whole or in part) The RPT device 4000 is configured to execute any of the methods described herein. may be administered to a patient, for example for the treatment of one or more of the respiratory conditions described herein. 4A-4D are schematic diagrams showing the configuration of the airflow delivery device. FIG. 4000 is a schematic diagram that may include an illustrative example of an RPT device.

[0055] The RPT device may have an outer housing 4010. The outer housing 4010 includes an upper The housing is formed of two parts, a first part 4012 and a second part 4014. The group 4010 may include one or more panels 4015. 4000 includes a chassis 401 that supports one or more internal components of the RPT device 4000. 6. The RPT device 4000 may include a handle 4018.

[0056] 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 supplying air at positive pressure A pressure generator 4140 (e.g., blower 4142), an outlet muffler 4124, and one The transducer 4270 includes a pressure sensor 4272 and a flow sensor 4274. obtain.

[0057] One or more of the air path items may be a removable air block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by a chassis 4016. The chassis 4016 may be supported by or formed as part of the chassis 4016 .

[0058] The RPT device 4000 includes a power source 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more A protection circuit 4250, a memory 4260, a converter 4270, and a data communication interface 4 280, and one or more output devices 4290. The 4200 is mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative, the RPT device 4000 may be mounted on more than one PCB. It may contain A4202. 5.4.1 RPT Device Mechanical and Pneumatic Components

[0059] 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 are included in each separate unit: It can be arranged as 5.4.1.1 Air filters

[0060] 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 data 4110.

[0061] In one form, the inlet air filter 4112 is located in the air pressure path upstream of the pressure generator 4140. It is placed at the beginning.

[0062] In one form, the outlet air filter 4114 (e.g., antibacterial factor) is a pneumatic block. 4020 and the patient interface 3000. 5.4.1.2 Mufflers

[0063] The RPT device according to one form of the present technology includes a muffler 4120 or multiple mufflers 412 May include 0.

[0064] In one form of the present technology, the inlet muffler 4122 is connected to the pressure generator 4 in the air pressure path. It is located above 140.

[0065] In one form of the present technology, the outlet muffler 4124 is connected to the pressure generator 4 in the air pressure path. 140 and the patient interface 3000. 5.4.1.3 Pressure generator

[0066] In one form of the present technology, a pressure generator 41 that generates an air flow or supply at positive pressure. 40 is a controllable blower 4142. For example, the blower 4142 may be a blower housing A brushless DC motor with one or more impellers housed within a rotor, e.g., a volute. The blower may include a motor 4144. The blower may be configured to deliver an air supply of, for example, up to about 120 liters per minute. at a rate of about 4 cmH2O to about 20 cmH2O, or in other forms The blower can be operated up to about 30cmH2O. The following patents and patent applications are related to the blower: No. 6,399,433, which is incorporated herein by reference in its entirety. US Patent No. 7,866,944, US Patent No. 8,638,014, US Patent No. 8,63 No. 6,479 and PCT Patent Application Publication No. WO2013 / 020167.

[0067] The pressure generator 4140 is under the control of the treatment device controller 4240 .

[0068] In other embodiments, the pressure generator 4140 may be a piston-driven pump, a high pressure source (e.g., a compressed The pressure regulator may be connected to an air reservoir, or a bellows. 5.4.1.4 Converters

[0069] 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 in the air circuit. The external transducer may form part of the patient interface (e.g., a non-contact sensor). (e.g., a Doppler transmitter or receiver for transmitting or moving data RPT devices) radar movement sensor).

[0070] In one form of the present technology, one or more transducers 4270 are provided upstream and downstream of the pressure generator 4140. One or more transducers 4270 may be positioned downstream of or adjacent the airflow. to generate a signal (e.g., flow, pressure, or temperature at that point in the pneumatic path). The device may be constructed and arranged as follows:

[0071] In one form of the present technology, one or more transducers 4270 are connected to the patient interface 3000. may be located in the vicinity of

[0072] In one form, the signal from the converter 4270 is filtered (e.g., low pass, high pass or The signal may be filtered (by end-pass filtering). 5.4.1.4.1 Flow Sensors

[0073] The flow sensor 4274 according to the present technology is a differential pressure transducer (e.g., SENSIRIO The pressure transducer may be based on the SDP600 series differential pressure transducer from N.

[0074] In one embodiment, a signal indicative of flow rate from the flow sensor 4274 is transmitted to the central controller 423. Received by 0. 5.4.1.4.2 Pressure Sensors

[0075] A pressure sensor 4272 according to the present technology can be placed in fluid communication with the air pressure path. One example of a force sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is the NPA series from GENERAL ELECTRIC. There are converters from

[0076] In one form, the signal from the pressure sensor 4272 is transmitted to the central controller 4230. It is received as: 5.4.1.4.3 Motor Speed ​​Converters

[0077] In one form of the present technology, the rotational speed of the motor 4144 and / or the blower 4142 is determined. A motor speed converter 4276 may be used to determine the speed of the motor. The motor speed signal may be provided to the therapy device controller 4240. The sensor 4276 may be, for example, a speed sensor (e.g., a Hall effect sensor). 5.4.1.5 Anti-spillback valves

[0078] In one form of the present technology, an anti-spillback valve 4160 is provided between the humidifier 5000 and the air pressure The anti-spillback valve may be disposed between the humidifier 5000 and the block 4020. The structure is configured to reduce the risk of air flowing upstream (e.g., to the blower motor 4144). Built and deployed. 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply

[0079] The power supply 4210 may be internal or external to the external housing 4010 of the RPT device 4000. It can be arranged.

[0080] In one form of the present technology, the power supply 4210 is configured to provide power only to the RPT device 4000. In another form of the present technology, power is supplied from a power source 4210 to the RPT device 4000 and The heater 5000 is provided with a heater 5000 and a humidifier 5000. 5.4.2.2 Input Devices

[0081] In one form of the present technology, the RPT device 4000 allows a human to interact with the device. one or more input devices 42 in the form of buttons, switches, or dials for 20. Buttons, switches or dials are accessed via the touch screen. It can be a physical or software device that allows a user to The switch or dial may be physically connected to the outer housing 4010 in one form. or a receiver electrically connected to the central controller 4230 in another form. Wireless communication may also be performed.

[0082] In one form, the input device 4220 allows a human to select values ​​and / or menu options. The present invention may be constructed and arranged to allow the user to select 5.4.2.3 Central Controller

[0083] In one form of the present technology, the central controller 4230 controls the RPT device 4000. One or more processors suitable for

[0084] A suitable processor is the ARM Cortex from ARM Holdings. (registered trademark) -M processor-based processor, x86 INTEL processor (e.g., the S®32 series microcontrollers from STMicroelectronics) In certain alternatives of the present technology, a 32-bit RISC CPU (e.g., ST Micro Electronics STR9 series macro controllers or 16-bit RISC CPU (e.g., a computer manufactured by TEXAS INSTRUMENTS) Processors from the MSP430 family of microcontrollers may also be suitable.

[0085] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0086] In one form, the central controller 4230 is an application specific integrated circuit. In the embodiment, the central controller 4230 includes discrete electronic components.

[0087] The central controller 4230 controls one or more transducers 4270, one or more input devices 42 20 and the humidifier 5000.

[0088] The central controller 4230 transmits the output signal(s) to the output device 4290, the therapy device controller 4292, Controller 4240, Data Communication Interface 4280 and Humidifier 5000 The device may be configured to provide the signal to one or more

[0089] In some forms of the present technology, the central controller 4230 may include one or more of the configured to embody one or more methods (e.g., a non-transitory computer readable A computer program stored in a recording medium (e.g., memory 4260) In some embodiments of the present technology, one or more algorithms are represented as Thus, the central controller 4230 may be integrated with the RPT device 4000. However, In some forms of the technology, some methods include a remotely located device For example, the remotely located device may store the recorded data (e.g., The analysis of the ventilator's control settings is based on the The respiratory-related event may be detected or a respiratory-related event may be determined. 5.4.2.4 Clock

[0090] The RPT device 4000 includes a clock 4232 connected to a central controller 4230. obtain. 5.4.2.5 Therapy Device Controller

[0091] In one form of the present technology, the therapy device controller 4240 includes a therapy control module 43 30, which is part of the algorithm 4300 executed by the central controller 4230. Form.

[0092] In one form of the present technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brush manufactured by ONSEMI A DC motor controller is used. 5.4.2.6 Protection circuit

[0093] One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure regulation. It may include the entire circuit. 5.4.2.7 Memory

[0094] 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 RAM. In some forms, the memory 4260 may include volatile RAM. .

[0095] The memory 4260 may be located on the PCBA 4202. The memory can take the form of M or NAND flash.

[0096] Additionally or alternatively, the RPT device 4000 may include a removable memory 4260 ( For example, memory cards made according to the Secure Digital (SD) standard.

[0097] In one form of the present technology, the memory 4260 is a non-transitory computer readable storage medium. The recording medium functions as a computer readable medium that expresses one or more of the methods described herein. Computer program instructions (eg, one or more algorithms 4300) are recorded. 5.4.2.8 Data communication systems

[0098] In one form of the present technology, a data communication interface 4280 is provided to The data communication interface 4280 is connected to a remote external communication network. network 4282 and / or a local external communications network 4284. The remote external communications network 4282 can be connected to a remote external device 4286. The local external communication network 4284 may include a local external device 4288 may be connectable to

[0099] In one embodiment, the data communication interface 4280 is In another embodiment, the data communication interface 4280 is a part of a central control. The controller 4230 may be separate from the controller 4230 and may include an integrated circuit or processor.

[0100] In one embodiment, the remote external communications network 4282 is the Internet. The communication interface 4280 is a digital signal processor (e.g., Ethernet) for connecting to the Internet. The communication may be via wired communication (e.g., through a wired or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE) can be used.

[0101] In one embodiment, the local external communication network 4284 is compatible with one or more communication standards (e.g., For example, Bluetooth or consumer infrared protocols.

[0102] In one embodiment, the remote external device 4286 may include one or more computers (e.g., a network In one embodiment, the remote external device 428 6 may be a virtual computer rather than a physical computer. In either case, Such remote external devices 4286 may be operated by appropriately authorized humans (e.g., clinicians). These may be accessible.

[0103] The local external device 4288 can be a personal computer, a mobile phone, a tablet or may be a remote control. 5.4.2.9 Optional displays and output devices, including alarms

[0104] The output device 4290 according to the present technology may include one or more of visual, audio, and tactile units. 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. 5.4.2.9.1 Display Drivers

[0105] The display driver 4292 outputs characters, symbols, etc. to be displayed on the display 4294. or an image as input and displays these characters, symbols or images on the display 4294. into a command that displays the 5.4.2.9.2 Display

[0106] The display 4294 responds to commands received from the display driver 4292. The display is configured to visually display characters, symbols, or images. The display 4294 may be an eight-segment display, in which case the display driver 42 92 represents each character or symbol (e.g., the number "0") as a specific character or symbol. The input signal is converted into eight logic signals indicating which of the eight segments should be activated for the input signal. 5.4.3 RPT Device Algorithm

[0107] As mentioned above, in some forms of the present technology, the central controller 4230 may A computer readable medium (e.g., memory 4260) may be used to read data stored in the computer. To embody one or more algorithms 4300 expressed as computer programs. The algorithm 4300 can be organized into groups called modules. It is common for this to be followed by a ". 5.4.3.1 Pre-processing module

[0108] 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 a signal from a pressure sensor 4274 or pressure sensor 4272 as an input and outputs one or more These output values ​​are then used to calculate the output of another module. The treatment engine module 4320 may use the treatment engine module 4320 as an input to the treatment engine module 4320. It can be depicted as shown in D.

[0109] In one form of the present technology, the output values ​​are the interface or mask pressure Pm, the respiratory flow rate Includes Qr and leakage flow Ql.

[0110] In various forms of the present technology, the pre-processing module 4310 may use one of the following algorithms: Includes one or more of: Pressure Compensation 4312, Air Flow Estimation 4314, Leakage Flow Estimation 4316, and and respiratory flow estimation 4318. 5.4.3.1.1 Pressure compensation

[0111] In one form of the present technology, the pressure compensation algorithm 4312 The pressure compensation algorithm 431 receives as an input a signal indicative of the pressure in the air pressure path at the 2 estimates the pressure drop through the air circuit 4170 and The estimated pressure Pm is provided as an output. 5.4.3.1.2 Estimation of air flow rate

[0112] In one form of the present technology, the airflow estimation algorithm 4314 is 3000 as an input and ventilating the patient interface 3000. The air flow rate Qv of the air through the hole 3400 is estimated. 5.4.3.1.3 Estimation of leakage flow rate

[0113] In one form of the present technology, the leakage flow estimation algorithm 4316 calculates the total flow Qt and It receives the airflow Qv as an input and provides an estimate of the leakage flow Ql as an output. The leak flow estimation algorithm is performed over a period of several respiratory cycles (e.g., about 10 seconds). Calculate the average difference between the total flow Qt and the ventilation flow Qv over a period long enough to By this, the leakage flow rate Ql is estimated.

[0114] In one form, the leakage flow estimation algorithm 4316 provides as an output the leakage flow rate Ql. and calculate the leakage conductance and the leakage flow rate Ql as the leakage conductance and The total pressure in the patient interface 3000 is determined to be a function of the pressure Pm. It receives as input the volumetric flow rate Qt, the ventilation flow rate Qv, and the estimated pressure Pm. The flow rate is the low-pass filtered unvented flow rate equal to the difference between the total flow rate Qt and the vented flow rate Qv. It is calculated as the quotient of the flow rate and the low-pass filtered square root of the pressure Pm, The time constant has a value sufficient 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: .

[0115] A sudden leakage change means that the leakage flow rate estimation algorithm 4316 does not keep up with the initial change. Time scales shorter than the time scales on which the In certain treatment modes, the and require special handling as described below. 5.4.3.1.4 Respiratory flow estimation

[0116] In one form of the present technology, the respiratory flow estimation algorithm 4318 calculates total airflow Qt, ventilation flow The system receives the amount Qv and the leakage flow rate Ql as inputs and calculates the total amount Qv and the leakage flow rate Ql. Estimate the respiratory flow of air to the patient, Qr, by subtracting it from the flow, Qt. 5.4.3.2 Treatment Engine Module

[0117] In one form of the present technology, the therapy engine module 4320 is Receives as input one or more of the pressure Pm in the blood and the respiratory flow rate Qr of air to the patient. , providing one or more treatment parameters as output.

[0118] In one form of the present technology, the treatment parameter is a treatment pressure, Pt.

[0119] In one form of the present technology, the treatment parameters include the amplitude of pressure change, the base pressure and the target pressure. One or more of the tidal volumes.

[0120] In various embodiments, the treatment engine module 4320 may implement one of the following algorithms: Includes at least one of: Phase determination 4321, Waveform determination 4322, Tidal volume estimation 4323, and and treatment parameter determination 4329. 5.4.3.2.1 Phase Determination

[0121] In one form of the present technology, the RPT device 4000 may determine the respiratory phase.

[0122] In one form of the present technology, the phase determination algorithm 4321 determines a signal indicative of respiratory flow Qr. The stimuli 1000 receive as input the phase of the current respiratory cycle of the patient 1000 as output Π. Provide.

[0123] In some forms, the phase output Π, known as the discrete phase decision, is calculated using the discrete variables One implementation of discrete phase determination produces a binary phase output with values ​​of inspiration or expiration. The force Π is obtained by calculating the force Π when the start of spontaneous inspiration and expiration is detected, e.g. These are expressed as values ​​of 0 revolution and 0.5 revolution respectively. The RPT device 4000 effectively performs discrete phase decisions because the trigger points and The cycle points are the moments when the phase changes from expiration to inspiration and from inspiration to expiration, respectively. In one implementation of a binary phase decision, the phase output Φ is When the quantity Qr has a value exceeding a positive threshold, it has a discrete value of 0 (which causes the RPT device The value of Qr becomes more negative than the negative threshold ("triggering" the 4000). A discrete value of 0.5 revolutions at certain times (this allows you to "cycle" the RPT Device 4000) The inhalation time Ti and the exhalation time Te are determined so as to have the following inhalation time Ti and exhalation time Te (indicating inhalation) The amount of time spent with phase Φ equal to 0 (indicating exhalation) and 0.5 (indicating expiration), respectively. It may be a typical value extrapolated over many respiratory cycles.

[0124] Another embodiment of the discrete phase determination is one of inhalation, a pause during inhalation, and exhalation. A three-valued phase output Φ with a value is obtained.

[0125] 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 0 and 2Φ radians. The RPT device 4000 performs continuous phases reaching 0 revolutions and 0.5 revolutions respectively. In one embodiment of a continuous phase determination, The flow rate Φ is calculated by first calculating the respiratory flow rate Qr as above, similar to the inhalation time Ti and the exhalation time Te. Then, the continuous phase Φ at any hypothetical instant is estimated by the preceding trigger instant Half the fraction of the inspiration time Ti that has elapsed since the previous cycle instant or 0.5 revolutions The proportion of the exhalation time Te that was . 5.4.3.2.2 Waveform determination

[0126] In one form of the present technology, the treatment parameter determination algorithm 4329 determines the patient's respiratory cycle. Provides near constant therapeutic pressure throughout the entire treatment.

[0127] In another form of the present technology, the therapy control module 4330 controls the pressure generator 4140. and varies as a function of the phase Φ of the patient's respiratory cycle according to a waveform template Π(Φ). The therapeutic pressure Pt is then provided.

[0128] 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 treatment parameter determination algorithm 4329. The variation of the phase value Φ provided by the phase determination algorithm 4321 to be used The range for the pixel is [0, 1].

[0129] In one form, the waveform tempo is used as a function of the discrete or continuous phase. Plate Π(Φ) is a square wave template with a phase of 1 for phase values ​​up to 0.5 revolutions. and a value of 0 for phase values ​​greater than 0.5 revolutions. For a continuously-valued phase, the waveform template Π(Φ) is the sum of two averages Includes smoothly curvilinear parts (i.e., smoothly curvilinear for phase values ​​up to 0.5 revolutions) (e.g., a raised cosine) of 0 to 1, and phase values ​​greater than 0.5 revolutions A smoothly curvilinear (e.g., exponential) decline from 1 to 0 with respect to For a phase that takes on continuous values, the waveform template Π(Φ) is based on a square wave. However, the smoothing from 0 to 1 occurs for phase values ​​up to a "rise time" lower than 0.5 revolutions. It has a smooth rise and falls from 1 to 0 for the phase value within the "fall time" after 0.5 rotations, 0. It has a smooth descent with a "descent time" of less than 5 revolutions.

[0130] In some forms of the present technology, the waveform determination algorithm 4322 is Select a waveform template Π (Φ) from the waveform template library according to your settings Each waveform template Π(Φ) in the library is a lookup table for the phase value Φ. In another embodiment, the waveform determination algorithm 4322 may be provided as a table value Π. A given functional form (possibly with one or more parameters (e.g., the exponential curve part) The waveform template Π(Φ) is parameterized by the time constant The parameters of the function form may be predetermined or may be calculated by Alternatively, it may depend on the current condition of the patient 1000.

[0131] This technique is suitable for the 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 “on-the-fly” as a function of the measured discrete phase Φ and time t. In one such embodiment, the waveform determination algorithm 4322 calculates The waveform template Π(Φ, t) is calculated in two parts (inhalation and exhalation) as follows: Calculate.

number

[0132] Here, Π i (t) and Π e (t) is the inhalation and exhalation part of the waveform template Π(Φ, t). In one such embodiment, the inspiratory portion Π of the waveform template i ( t) is a smooth rise from 0 to 1 parameterized by the rise time, Template expiratory part Π e (t) is a ramp from 1 to 0 parameterized by the fall time It is a smooth decline of. 5.4.3.2.3 Tidal volume estimation

[0133] In some forms of the present technology, a central controller 4230 controls the therapy engine module. A single conversion is performed using values ​​returned from one or more of the other algorithms in Rule 4320. Execute one or more tidal volume estimation algorithms 4323 for estimating air volume.

[0134] In one form of the present technology, the tidal volume estimation algorithm 4323 is a phase determination algorithm. The input is a signal indicating the respiratory flow rate Qr and phase Φ determined by rhythm 4321. The tidal volume of the most recent breath, V T The tidal volume V is returned as an estimate. T Is breathing the inhaled (tension) volume during breathing, Vi, the exhaled (tension) volume during breathing, Ve, or a fixed combination of the two. The intake volume Vi may be estimated as a combination (e.g., a mean or average). is estimated as the integral of the respiratory flow Qr during the inspiratory portion of the breath (indicated by the phase φ of The expiratory volume Ve can be calculated by the expiratory portion of the breath (indicated by a phase φ of 0.5 or more). It can be estimated as the integral of respiratory flow Qr over 5.4.3.2.4 Determination of treatment parameters

[0135] 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. one or more treatment parameter determination algorithms for determining the treatment parameters on Execute.

[0136] In one form of the present technology, the treatment parameter is the instantaneous treatment pressure Pt. In the current example, the treatment parameter determination algorithm 4329 determines the treatment parameter using the following equation: The pressure Pt is determined.

number

[0137] where: ● A is the amplitude, ● Π(Φ, t) is the current value of the phase Φ and the phase t (in the range 0 to 1) ) waveform template value, ● P0 is the base pressure.

[0138] The waveform determination algorithm 4322 performs a lookup of the value Φ indexed by the phase. When the waveform template Π(Φ, t) is provided as a data table, the treatment parameter decision algorithm The algorithm 4329 determines the current state of the phase returned from the phase determination algorithm 4321. Locating the closest lookup table entry for the current value of Φ or the phase Apply equation (1) by interpolating between the two inputs that span the current value of Φ.

[0139] The values ​​of Amplitude A and Base Pressure P0 determine the treatment parameters depending on the selected respiratory pressure treatment mode. This may be set by the meter determination algorithm 4329. 5.4.3.3 Treatment Control Module

[0140] The therapy control module 4330 according to one aspect of the present technology includes a therapy engine module 4320. receiving as input treatment parameters from a treatment parameter determination algorithm 4329; to deliver airflow from the pressure generator 4140 in accordance with these treatment parameters, Controls the pressure generator.

[0141] In one form of the present technology, the treatment parameter is a treatment pressure Pt, and the treatment control module 4 330 indicates that the mask pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt. The pressure generator is controlled to cause a gentle air flow from the pressure generator 4140. 5.4.3.4 Detecting Fault Conditions

[0142] In one form of the present technology, a central controller 4230 may include one or more Execute the method 4340 above. A fault condition detected by one or more of the methods 4340 may include: May include at least one of the following: ● Power outage (no power or insufficient power) ● Converter failure detection ● Unable 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.

[0143] When a fault condition is detected, the corresponding algorithm 4340 signal is one or more of the following: Signal the presence of a fault by: ● Initiating audible, visual and / or kinetic (e.g. vibration) warnings. ● Sending messages to external devices Incident logging 5.5 Air Circuit

[0144] The air circuit 4170 according to one aspect of the present technology has two components for air flow in use. between the patient interface 3000 and the RPT device 4000. The conduit or tube is constructed and arranged to provide a

[0145] In particular, the air circuit 4170 is connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb airway is used. A circuit is used. 5.6 Humidifier

[0146] In one form of the present technology, the absolute humidity of the air or gas to be delivered to the patient is adjusted relative to the ambient air. A humidifier 5000 for varying the relative humidity is provided (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 humidifies the air stream (ambient air) before delivery to the patient airway. It is used to increase the absolute humidity (relative to the humidity) and to increase the temperature.

[0147] The humidifier 5000 includes a humidifier reservoir 5110 and a humidifier inlet 5002 for receiving an air flow. and a humidifier outlet 5004 for delivering a humidified air flow. In some configurations, such as that shown in FIG. 5B, the inlet of the humidifier reservoir 5110 and The outlets may be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier may further include a humidifier base 5006. The humidifier base 5006 is The heater 5240 may be adapted to receive the server 5110 and may include a heating element 5240. 5.7 Respiratory waveform

[0148] FIG. 6 shows a model of a typical human respiratory waveform during sleep. The horizontal axis is time and the vertical axis is the respiratory flow rate. Because parameter values ​​can vary, a typical breath is approximately Can have values: tidal volume, Vt, 0.5L, inspiration time, Ti, 1.6 seconds, peak inspiratory flow volume, Qpeak, 0.4L / sec; expiratory time, Te, 2.4s; peak expiratory flow, Qpeak, -0.5 L / sec. The total duration of a breath, Ttot, is about 4 seconds. A human typically takes The patient is breathing about 15 times a day (BPM) and has a ventilation rate of about 7.5 L / min. The ratio of the ideal duty cycle, Ti, to Ttot is approximately 40%. 5.8 Respiratory Pressure Therapy Mode

[0149] The treatment parameters 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 modes are possible. The download can be performed by the RPT device 4000.

[0150] In some implementations of this form of technology, the amplitude A of the treatment pressure equation (1) is equal to Since the therapeutic pressure Pt is zero, it is equal to the base pressure P0 throughout the entire respiratory cycle. Such embodiments are primarily grouped under the heading of CPAP therapy. In other implementations of this aspect of the technology, the value of the amplitude A in equation (1) is positive. Such an implementation is known as bilevel therapy because the treatment pressure Pt is increased by a positive amplitude A When the treatment parameter determination algorithm 4329 uses the equation (1), The therapeutic pressure Pt is oscillated between two values ​​or levels in synchronization with the spontaneous breathing efforts of the patient 1000. That is, based on the above-mentioned typical waveform template Π(Φ,t), Therapy parameter determination algorithm 4329 determines the therapy pressure at the beginning or during inspiration. Increase Pt to P0+A (known as IPAP) and administer therapy at the beginning or during expiration. The treatment pressure Pt is reduced to a base pressure P0 (known as EPAP).

[0151] In some forms of bilevel therapy, the amplitude A is set to the amplitude at which the RPT device 4000 The ventilator is large enough to perform some or all of the respiratory work of 1,000 patients. 000. Pressure-support ventilation therapy or pressure-controlled ventilation therapy In this form, known as pressure assist, the amplitude A is called the pressure assist or swing. In force support ventilation therapy, IPAP is the base pressure P0 + pressure support A, and EPAP is The base pressure is P0.

[0152] In some forms of pressure support ventilation therapy, known as constant pressure support ventilation therapy, pressure support is The pressure support A is fixed at a predetermined value (e.g., 10 cmH2O). The predetermined pressure support value is RP For example, when configuring the RPT device 4000, The number of entries may be entered by input device 4220 or may be set by manual input via input device 4220.

[0153] In another form of pressure-support ventilation therapy, commonly known as servo-ventilation, the treatment parameters The decision algorithm 4329 determines whether a given current measured or estimated respiratory cycle The parameters and the target values ​​of the respiratory parameters are taken as inputs, and the equation (1) is Continuously adjusts parameters to bring the current measurement of a respiratory parameter closer to the target value. The respiratory parameters are adjusted to the tidal volume V T As an example of servo ventilation, There is a certain amount of time called a mode.

[0154] In some forms of servo ventilation, the therapy parameter determination algorithm 4329 Repeat Pressure Assist A to adjust the current measurement of the aspirator parameter to the target value. A servo control method is applied to calculate the proportional integral. In one implementation of PI control for the safe volume mode, the current pressure The adjustment ΔA for Auxiliary A is calculated as follows:

number

[0155] where G is the servo control gain and Cnom is the nominal compliance constant. (This is typically set at 60 ml / cmH2O for adults and 40 for children. ml / cmH2O, but may be altered for different patient subtypes), V T (Target) is the target tidal volume (unit: milliliters). The gain G is typically It is a constant value of 1.

[0156] Other servo control methods that may be applied by the treatment parameter determination algorithm 4329 are listed below. These are Proportional (P), Proportional Differential (PD), and Proportional Integral Differential (PID).

[0157] The value of the pressure assist A calculated via equation (2) is defined as [Amin, Amax]. In this embodiment, the pressure support A is adjusted to the tidal volume V T The measurement of the target ventilation volume V T At minimum pressure support Amin until it falls below (target) The tidal volume V T When the measurement falls below the target tidal volume At , A starts to increase, and V T V again T Amin only if it exceeds (target) It drops to.

[0158] 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 via 5.8.1 Handling sudden leakage changes

[0159] In the event of a sudden change in leakage (sudden occurrence or elimination of leakage), the leakage flow rate Ql , which results in an estimate of the respiratory flow Qr, This may cause temporary inaccuracies while the 6 "catches up" to this sudden change. At times, the respiratory flow Qr increases over a period lasting perhaps several breaths. Next, when the leak is eliminated, the respiratory flow rate Qr decreases over a certain period of time. In addition, the phase determination algorithm 4321 determines the inhalation and exhalation portions of the breath. As a result, when a leak appears, the intake The amount of air flow Vi tends to be temporarily overestimated, and the amount of air flow Ve tends to be temporarily underestimated. When the leakage is eliminated, the expiratory volume Ve tends to be temporarily overestimated. Therefore, the inhalation volume Vi tends to be temporarily underestimated. Tidal volume V according to estimation algorithm 4323 T The estimate of the actual tidal volume is calculated temporarily. As a result, in the safe volume mode, pressure support A may be inappropriately reduced. Or it will increase slower than it should. Figure 7A shows such behavior. The graph 7100 includes a graph 7100 showing an example of the movement. Traces 7110-7130 in the graph 7100 are , (not the parameters estimated by the RPT device 4000 using the algorithm 4300) i) Direct measurement of various respiratory parameters. The top trace 7110 shows the pressure-assisted A The middle trace 7120 shows the treatment pressure Pt fluctuating with an amplitude equal to The lower trace shows the respiratory flow Qr fluctuating between the positive (inhalation) and negative (expiration) portions of the respiratory flow. Trace 7130 shows the integral (i.e., instantaneous) of respiratory flow Qr. The peak value of the peak during 30 is the tidal volume V of each successive breath. T Shows.

[0160] At 7140, a leak suddenly occurred. Immediately afterwards, the tidal volume was overestimated. This causes a large drop in pressure support, which then returns to its previous value after about a dozen breaths. As a result, the delivered tidal volume V T The leakage is eliminated at 7150, After a significant drop in pressure support due to the tidal volume being overestimated again, It takes many breaths to return to the original value, during which the delivered tidal volume V T Also significantly lower Lower.

[0161] In one form of the present technology, to reduce this effect of sudden leakage changes, The servo control gain G can be dynamically adjusted. One effect of the current or future implementation of the sedative is that the estimates of the inhaled and exhaled volumes Vi and Ve are temporarily misaligned. Therefore, in one execution, the estimation of the inhalation volume Vi and the estimation of the exhalation volume Ve are and a servo control based on this difference such that the difference between the two decreases as the difference between Adjust the gain G. In one such implementation, the relative difference tidal volume dv is adjusted to a lower value d The servo control gain, vmin, varies between vmin and a default value (e.g., 1). G is adjusted linearly between a default value and a lower value Gmin. The figure shows an example of adjusting the servo control gain G. In the figure, the default value is 1, and the lower value Gmi n is 0.2, and the lower limit dvmin is also 0.2. The relative difference tidal volume dv is expressed as As well as the adjustment to ensure that it is never zero, it can be calculated from the most recent breath as follows: .

number

[0162] This implementation allows the measurement of the inhalation volume Vi and exhalation volume Ve due to the sudden appearance or disappearance of the leak. The estimation is subject to temporary variations, which slows down the adjustment speed of Pressure Support A. After these estimates converge as the algorithm 4316 catches up with the sudden leakage change, the servo control The control gain G returns to its normal value of 1. This ensures that a sudden leakage change does not affect the pressure assist servo control. The effect on control is smoothed out, resulting in more stable control even when a sudden leakage change is encountered. Treatment can be provided.

[0163] Graph 7200 included in FIG. 7B shows the treatment parameters in one such implementation of the present technology. 7A, the behavior of the data determination algorithm 4329 is shown. The bases 7210 to 7230 are (RPT device 4000 using algorithm 4300). Direct measurements of various respiratory parameters (rather than estimated parameters) are shown. Top traces 7210 shows the therapeutic pressure Pt, the middle trace 7220 shows the respiratory flow Qr, and the bottom trace Base 7230 shows the integral (i.e., instantaneous volume) of respiratory flow Qr.

[0164] A sudden leak appears at 7240, but the decrease in pressure support A is due to the The result is a reduction in the delivered tidal volume. The drop in the 7250 is also smaller than the drop in the 7130 at the same stage. This eliminates the leak and causes the Gain Pressure Auxiliary A to drop much less than the drop in trace 7110. The decrease in delivered tidal volume corresponds to the decrease in trace 7130 at the same stage. Therefore, if a sudden change in leakage is encountered, the delivered tidal volume V T The change in is significantly smaller.

[0165] FIG. 9 illustrates a method 9000 for dynamically adjusting the servo control gain G in the form of an algorithm. The level flow chart shows the algorithm for the respiratory therapy device (RPT4000). Executed within the treatment engine module 4320 or as a separate module within In block 9004, the algorithm determines if a sudden leakage change is detected. As shown in Figure 7A, the detection of a sudden leak can be triggered by a pressure assist or a one-time The determination of sudden leakage can be made in response to changes in ventilation. Above a certain threshold dvmin for a period of time (e.g., a single or multiple breaths) Based on the increase in the exhaled volume Ve and the relative difference between the tidal volume dv (see equation (3)) If a sudden leak is detected, then in block 9008, the estimated quantity value V The servo control gain G of the device is adjusted based on the difference between i and the estimated quantity value Ve. As shown in FIG. 8 and as defined in equation (3), this adjustment is based on the default or normal The linear change occurs based on the relative difference in tidal volume dv between the upper and lower minimum values ​​Gmin. In this way, the gain G is dynamically adjusted in response to sudden leakage. By servo-controlling the degree of support according to the natural leakage, This improves performance, reducing the impact of leakage and therefore the operation in safe mode. The effect of leakage on ventilation performance is also reduced, and changes in the ventilation support used should reflect this effect. It can be done.

[0166] At decision diamond 9012, we examine the difference between Vi and Ve to see if there is convergence ( For example, if the difference between Vi and Ve is within a certain range (e.g., the relative difference is 20% or less), If there is convergence, in block 9016, the gain G is set to the normal value Or return to a default value (e.g., 1). If there is no convergence, at block 9008 The gain G is adjusted according to the relative difference between the estimated inhalation volume Vi and the estimated exhalation volume Ve. This allows for a further level of dynamic adjustment. For example, Based on the calculated relative difference tidal volume dv as shown in Figure 8, the convergence criterion is met. Based on this, the gain G can be adjusted linearly.

[0167] In another implementation, blocks 9004, 9012 and 9016 are not used and block 90 08 is repeatedly called to calculate the difference between the estimated quantity value Vi and the estimated quantity value Ve. The servo control gain G of the device is adjusted accordingly.

[0168] As an example, a respiratory treatment device including a pressure generator, a transducer, and a controller may be used in accordance with the present technology. In this example, the pressure generator may be configured to operate according to the embodiment of the present invention. The converter then converts one of the air streams into a gas that is useful in the ventilation system. A signal indicative of the above characteristics may be generated. The controller may then process or analyze the signal. The controller estimates the inhaled and exhaled volumes for one or more patient breaths. Servo-controlling assistance to dynamically adjust based on the difference between estimates of inhaled and exhaled volumes Also configured to adjust the estimated tidal volume to be closer to the target volume using a gain. This allows for improvements in the associated adjustment of estimated tidal volume in the event of a sudden leak. become. 5.9 Glossary

[0169] For purposes of this disclosure, in certain embodiments of this technology, one or more of the following definitions may apply: In other aspects of the technology, other definitions may also apply. 5.9.1 General

[0170] Air: In certain forms of the present technology, air may mean the atmosphere, and in other forms of the present technology By air we mean a combination of other breathable gases (e.g., oxygen-rich air) obtain.

[0171] Atmosphere: In certain forms of the present technology, the term "atmosphere" refers to (i) the temperature of the treatment system or or external to the patient, and (ii) directly surrounding the treatment system or patient. should be taken as such.

[0172] For example, the atmosphere for a humidifier humidity can be the humidity of the air immediately surrounding the humidifier ( For example, the humidity inside the room where the patient is sleeping. The humidity level may be different from that outside the room where you are sleeping.

[0173] In another example, the atmospheric pressure may be the pressure immediately surrounding or external to the body.

[0174] In certain embodiments, the ambient (e.g., acoustic) noise may be generated, for example, from an RPT device. or noise generated by the mask or patient interface. It can be thought of as the background noise level in a room. Ambient noise is noise generated from sources outside the room. It can arise from.

[0175] Automatic positive airway pressure (APAP) therapy: Depending on the presence or absence of signs of SDB onset, e.g. For example, a CP that can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths. AP therapy.

[0176] 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, the pressure at the entrance to the airways is increased during exhalation. In some configurations, the pressure increases slightly during breathing and decreases slightly during inspiration. Varies between different respiratory cycles (e.g., in response to detection of an indication of partial upper airway obstruction) (increased in response to a notification of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0177] Flow rate: The instantaneous volume (or mass) of air delivered per unit time. Flow rate is the instantaneous volume In some cases, when referring to flow rate, it is meant to refer to a scalar quantity (i.e., a large In other cases, when referring to flow rate, it refers to a vector quantity (i.e. a quantity that has both magnitude and direction). Flow rate may be given the symbol Q "Flow rate" can also be simply called "flow" or "airflow."

[0178] In the patient breathing example, the flow is nominal for the inspiratory portion of the patient's breathing cycle. Since the total flow rate may be positive during the inhalation and exhalation portions of the patient's breathing cycle, the total flow rate may be negative during the exhalation portion of the patient's breathing cycle. Qt is the flow rate of air exiting the RPT device. Qv is the exhaled It is the flow rate of air exiting the vent to allow the gas to escape. The leakage flow rate Ql is is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow Qr is , is the flow rate of air received into the patient's respiratory system.

[0179] Humidifier: The word "humidifier" refers to the application of a therapeutically beneficial amount of air to improve the medical respiratory condition of a patient. Constructed, arranged or equipped with a physical structure capable of providing 1000 liters of water (H2O) vapor to an air stream. or a humidification device configured as such.

[0180] Leakage: The term "leakage" means air flow to or from the surroundings (air circuits In one embodiment, leakage occurs through the shield between the mask and the patient's face. In another embodiment, the leakage may occur due to imperfect sealing of the pipe. The term "leak" refers to the leakage of air from the elbow during invasive ventilation. It may also include air exhaled around the tracheostomy tube.

[0181] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is transmitted through pneumatic paths (e.g., air circuits). Noise carried to the patient by the tract and the patient interface and the air within it In one form, conducted noise is measured by measuring the sound pressure level at the end of the air circuit. This can be quantified.

[0182] Noise Radiation (Acoustic): In this document, radiated noise is the noise level that is carried to the patient by the surrounding air. In one form, radiated noise refers to the sound power / pressure level of interest. can be quantified by measuring according to ISO 3744.

[0183] Noisy ventilation (acoustic): In this document, ventilation noise refers to any ventilation (e.g., patient intake noise). This refers to noise generated by air flow through vents in the interface.

[0184] Patient: A person with or without respiratory disease.

[0185] Pressure: force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 Equal to , approximately 0.98 hectopascals. In this specification, unless otherwise specified, pressure is It is given in units of cmH2O.

[0186] The pressure in the patient interface is given the symbol Pm, and the mask pressure Pm The therapeutic pressure, which represents the target value to be achieved, is given the symbol Pt.

[0187] Respiratory Pressure Therapy (RPT): The supply of air at therapeutic pressure, which is typically positive relative to the atmosphere. Attachment to the feeding airway inlet.

[0188] Ventilator: A mechanical device that provides pressure support to a patient while performing some or all of the work of breathing. Chair. 5.9.2 Breathing cycle

[0189] Apnea: According to some definitions, an apnea is a period in which flow drops below a given threshold, e.g., 10 An obstructive apnea is said to have occurred when the patient is occurs when some form of airway obstruction does not allow air to flow despite the patient's efforts Central apnea is a condition in which the airway remains open but the effort to breathe is reduced or It is said to refer to a condition in which apnea is detected due to the absence of respiratory effort. It is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0190] Respiratory Rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0191] Duty Cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0192] Exercise (breathing): Respiratory effort is the movement made by a person trying to breathe. It is said to point.

[0193] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0194] Flow limitation: Flow limitation is a condition in which increased exertion by the patient does not cause a corresponding increase in flow rate. This is interpreted as the situation in a patient's breathing where there is flow limitation during the inspiratory portion of the respiratory cycle. When this occurs, the flow limitation can be referred to as inspiratory flow limitation. When flow limitation occurs in the expiratory flow region, the flow limitation can be referred to as expiratory flow limitation. do.

[0195] Hypopnea: By some definitions, hypopnea means a reduction in flow, rather than an interruption of flow. In one embodiment, if the flow falls below a threshold velocity for a sustained period of time, breathing If hypopnea is detected due to a decrease in respiratory effort, Central respiratory depression is said to occur. In adults, one of the following occurs: This may be considered hypopnea if: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction in patient respiration (less than 50%) lasting for at least 10 seconds and associated desaturation is at least 3% or awakening occurs.

[0196] Hyperventilation: An increase in flow to a level higher than normal.

[0197] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is called the inspiratory portion of the respiratory cycle. The intake portion of the valve is taken as the intake portion of the valve.

[0198] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. What is airway patency? , open. Quantification of airway patency can be done, for example, by dividing the airway patency into two categories: open (1) and closed (obstructed). This can be done with a value of (0) indicating

[0199] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0200] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0201] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): These terms are used interchangeably with R This may be understood to refer to the PT device's estimate of respiratory flow, usually expressed in liters / minute. This is used in contrast to "true respiratory flow" or "true flow rate," which is the actual respiratory flow of the patient. can be done.

[0202] Tidal volume (V T ): Inhaled or exhaled during normal breathing without extra effort In principle, the inspiration volume Vi (amount of inspired air) is proportional to the expiration volume Ve (amount of expired air). Since the single tidal volume V is equal to the volume of air ventilated T is equal to any quantity In practice, the tidal volume V T is any combination (e.g., this It is estimated as the average of two quantities.

[0203] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0204] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0205] (Total) Time (Ttot): The time between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform. The total duration between the start of the inspiration segment.

[0206] Typical recent ventilation: The tendency of recent values ​​of ventilation Vent to cluster together over a given time scale (i.e., the degree of central tendency of the most recent ventilation values).

[0207] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. The flow rate increases slightly or decreases with increasing pressure difference (Starling resistor behavior). This may be associated with a condition of possible flow limitation.

[0208] Vent: A measure of the rate of gas exchange performed by a patient's respiratory system. May include either or both of the inhaled and exhaled airflow per unit of time. Volume per minute When expressed as a volume, this amount is often called "minute ventilation." Minute ventilation is simply the volumetric Sometimes it is given as volume per minute, understood as volume per minute. 5.9.3 Ventilation

[0209] Adaptive servo ventilator (ASV): A servo that can be changed rather than having fixed target characteristics The changeable target characteristic can be any characteristic of the patient (e.g., the patient's respiratory characteristics) or can be learned from.

[0210] 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 respiratory rate of 100%.

[0211] Cycle: The end of the inspiratory phase of the ventilator. The spontaneously breathing patient is given a ventilator-assisted respiration. 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.

[0212] Expiratory Positive Airway Pressure (EPAP): The desired mask pressure that a ventilator attempts to achieve at a given time. Base pressure to which varying pressures are added within a breath to generate pressure.

[0213] End expiratory pressure (EEP): The pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. The desired mask pressure is determined by the pressure waveform template Π(Φ) having a value of zero at the end of expiration ( That is, if Π(Φ)=0 when Φ=1, then EEP is equal to EPAP.

[0214] Inspiratory positive airway pressure (IPAP): The maximum pressure that the ventilator attempts to achieve during the inspiratory portion of the breath. Desired mask pressure.

[0215] Pressure Support: A number indicating the increase in pressure during inhalation of the ventilator compared to exhalation of the ventilator. It mainly refers to the pressure difference between the maximum pressure during inspiration and the base pressure (e.g., PS = IP In some contexts, pressure support means the amount of pressure (that the ventilator actually achieves) that is This refers to the difference that the ventilator tries to achieve (rather than the difference it makes).

[0216] Servo-ventilator: A device that measures or estimates some parameter of the patient's respiratory cycle and adjusts the pressure Adjust the force assistance level to bring this measured parameter closer to the target parameter value. A ventilator that adjusts to.

[0217] 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 breathing for a period of time. If not, the device will automatically begin breath delivery.

[0218] Swing: A term equivalent to pressure assistance.

[0219] Trigger: When a ventilator delivers a breath of air to a spontaneously breathing patient, the patient must first initiate the breathing process. When the respiratory portion of the cycle is started, the ventilator is triggered to deliver a breath. say. 5.10 Other Notes

[0220] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner is If any person reproduces this patent document or this patent disclosure by facsimile, the patent file of the Patent Office will not be If it is something that is recorded in the records, there is no objection if it is for that purpose, but for other purposes All rights reserved.

[0221] Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, the lower limit 1 / 10th of a value, between the upper and lower limits of a range, and any other stated value or It is understood that each intervention value for each intervention value is included in the present technology. If the upper and lower limits of these intervention ranges included in If the range described includes one or both of these limitations, However, ranges beyond either or both of these stated limits are also encompassed by the technology.

[0222] 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 to the extent practical engineering practice permits or requires. It will be understood that such values ​​may be used to any suitable degree of significance.

[0223] Unless otherwise defined, all technical and scientific terms used herein are intended to be understood as meaning those to which the present technology pertains. The term "a" has the same meaning as that generally understood by a person skilled in the art. Any methods and materials similar or equivalent to the materials may be used in the practice or testing of the present technology. Although a limited number of exemplary methods and materials can be used in any of the above applications, the methods and materials are described herein. will be done.

[0224] Although certain materials are described as being suitable for use in the construction of components, the properties may not be comparable. Similar and obvious alternative materials may be used as substitutes. Therefore, any and all components described herein are understood to be manufacturable. As such, they can be produced collectively or separately.

[0225] As used herein and in the appended claims, the singular form "a" refers to "An" and "the" refer to the Please note that multiple equivalents are included.

[0226] All publications mentioned herein are incorporated by reference in their entirety for all purposes, including, but not limited to, the methods and / or methods that are the subject of those publications. The disclosures and descriptions of the materials herein are incorporated by reference. Any references herein are provided solely for their disclosure prior to the filing date of this application. The contents of this document also acknowledge that the present technology did not antedate such publications by virtue of prior patents. Further, the dates of publication listed should not be construed as being necessarily the actual publication dates. may vary and should be independently verified.

[0227] The words "comprises" and "comprising" mean elements, constituents, or steps in a non-exclusive sense and should be interpreted as referring to the An element, component or step is not specified in any way. This indicates that the information may be present in, utilized in, or combined with

[0228] 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 It should not be used to limit what appears in the claims as a whole. These headings are not intended to be limiting in any way in interpreting the scope of a claim or a claim limitation. It should not be used.

[0229] The technology herein has been described with reference to specific embodiments, but these embodiments are not intended to be limiting. It should be understood that these are merely illustrative of the principles and applications of the technology. In some cases, the terms and symbols may indicate specific details that are not necessary for the practice of the present technology. For example, the terms "first" and "second" (etc.) However, unless otherwise specified, these terms are not intended to imply any order. Further, the process steps in the method Although the descriptions or examples may be presented in a sequential order, such order is not required. Those skilled in the art will appreciate that such sequences may be altered and / or the aspects may be simultaneously performed. It will be appreciated that the above may be done synchronously or even synchronously.

[0230] Thus, numerous modifications may be made in the exemplary embodiments without departing from the spirit and scope of the present technology. It should be understood that variations are possible and other arrangements may be devised. 5.11 List of References patient 1000 Patient Interface 3000 Seal forming structure 3100 Plenum Chamber 3200 Structure 3300 Ventilation 3400 Connection port 3600 Forehead support part 3700 RPT Device 4000 External housing 4010 Internal part 4012 Part 4014 Panel 4015 Chassis 4016 Handle 4018 Pneumatic Block 4020 Air Filter 4110 Inlet Air Filter 4112 Outlet Air Filter 4114 Muffler 4120 Inlet muffler 4122 Exit muffler 4124 Pressure Generator 4140 Blower 4142 Motor 4144 Anti-spillback valve 4160 Air Circuit 4170 Electrical Components 4200 PCBA 4202 power supply 4210 Input Devices 4220 Central Controller 4230 Clock 4232 Treatment device controller 4240 Protection circuit 4250 Memory 4260 Converter 4270 Pressure Sensor 4272 Flow Sensor 4274 Motor Speed ​​Converter 4276 Data communication interface 4280 Remote external communication network 4282 Local external communication network 4284 Remote External Device 4286 Local Foreign Device 4288 Output device 4290 Display driver 4292 Display 4294 Algorithm 4300 Pre-processing module 4310 Pressure compensation algorithm 4312 Airflow estimation algorithm 4314 Leakage flow rate estimation algorithm 4316 Respiratory flow estimation algorithm 4318 Treatment engine module 4320 Phase Determination Algorithm 4321 Waveform determination algorithm 4322 Tidal volume estimation algorithm 4323 Treatment parameter determination algorithm 4329 Treatment Control Module 4330 How to detect fault conditions 4340 Humidifier 5000 Humidifier inlet 5002 Humidifier outlet 5004 Humidifier Base 5006 Humidifier Reservoir 5110 Humidifier Reservoir Dock 5130 heating element 5240 Graph 7100 Trace 7110 Trace 7120 Trace 7130 Graph 7200 Trace 7210 Trace 7220 Trace 7230 Sudden leak change 7240 Eliminate leaks 7250 method 9000 Block 9004 Block 9008 Judgement Diamond 9012 Block 9016

Claims

**Claim 1** An apparatus for treating a patient's respiratory disorder, comprising: a pressure generator that uses an air circuit to generate an air flow to provide assisted ventilation to the patient; a controller that adjusts the pressure of the assisted ventilation based on a difference between an estimated inhalation volume and an estimated exhalation volume of the patient's respiration when a sudden leak in the apparatus is detected, wherein the sudden leak is related to a state of an imperfect seal associated with an element of the air circuit; An apparatus comprising the above components. **Claim 2** The controller operates the pressure generator to generate an air flow using a servo control gain to provide the assisted ventilation, and the controller adjusts the servo control gain of the assisted ventilation based on a difference between an estimated inhalation volume and an estimated exhalation volume of the patient's respiration. The apparatus according to claim 1. **Claim 3** The servo control gain decreases as the difference between the estimated inhalation volume and the estimated exhalation volume increases. The apparatus according to claim 2. **Claim 4** The controller is configured to adjust the servo control gain, and the adjustment is linear between an upper value and a lower value as a relative difference tidal volume changes. The relative difference tidal volume is calculated based on a difference between the estimated inhalation volume and the estimated exhalation volume. The apparatus according to claim 2. **Claim 5** When the estimated inhalation volume and the estimated exhalation volume converge during the respiration of a patient wearing the apparatus, the controller adjusts the servo control gain to the upper value. The apparatus according to claim 4. **Claim 6** The controller detects the sudden leak based on a change in the assisted ventilation or the tidal volume. The apparatus according to claim 1. **Claim 7** The controller detects the sudden leak based on a difference between the estimated inhalation volume and the estimated exhalation volume. The apparatus according to claim 1. **Claim 8** The apparatus according to claim 1, further comprising a transducer that generates a signal indicating a characteristic of the air flow. **Claim 9** The estimated inhalation volume and the estimated exhalation volume are determined based on the signal, the signal is a flow signal, and the transducer is a flow sensor. The apparatus according to claim 8. **Claim 10** The apparatus according to claim 1, wherein the controller reduces the rate of change of the pressure of the auxiliary ventilation when detecting the sudden leakage.

11. A method of operating a respiratory therapy device that generates an air flow to provide auxiliary ventilation to a patient, comprising: generating, by a pressure generator, the air flow using an air circuit to provide the auxiliary ventilation to the patient; when a sudden leakage of the device is detected, adjusting, by a controller, the pressure of the auxiliary ventilation based on a difference between an estimated inspiratory volume and an estimated expiratory volume of the patient's respiration, wherein the sudden leakage is related to a state of an imperfect seal associated with an element of the air circuit; The method of operation comprising the steps of.

12. The controller operates the pressure generator using a servo control gain to generate an air flow to provide the auxiliary ventilation, and the adjusting step includes the controller adjusting the servo control gain of the auxiliary ventilation based on a difference between the estimated inspiratory volume and the estimated expiratory volume. The method of operation according to claim 11.

13. The adjusting step includes reducing the servo control gain as the difference between the estimated inspiratory volume and the estimated expiratory volume increases. The method of operation according to claim 12.

14. The adjusting step adjusts the servo control gain, and the adjustment is linear between an upper value and a lower value as a relative difference tidal volume changes, and the relative difference tidal volume is calculated based on a difference between the estimated inspiratory volume and the estimated expiratory volume. The method of operation according to claim 12, including adjusting.

15. The adjusting step includes adjusting the servo control gain to the upper value when the estimated inspiratory volume and the estimated expiratory volume converge during respiration of a patient wearing the device. The method of operation according to claim 14.

16. The method of operation according to claim 11, further comprising the step of the controller detecting a sudden leakage based on a change in auxiliary ventilation or tidal volume.

17. The method of operation according to claim 11, further comprising the step of the controller detecting a sudden leakage based on a difference between the estimated inspiratory volume and the estimated expiratory volume. The method of operation according to claim 11, wherein the transducer further comprises the step of generating a signal indicative of the characteristics of the air flow.

19. The method of operation according to claim 18, further comprising the step of determining the estimated intake air volume and the estimated exhaled air volume based on the signal, wherein the signal is a flow signal and the transducer is a flow rate sensor.

20. The method of operation according to claim 11, wherein the adjusting step further comprises reducing a rate of change of the pressure of the auxiliary ventilation when the sudden leak is detected.

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