TW201534361A - Method and apparatus for treatment of respiratory disorders - Google Patents

Abstract

Disclosed is an apparatus for treating a respiratory disorder. The apparatus comprises a pressure device, and a controller, including at least one processor, configured to control the pressure device to: supply, upon initiation of treatment, a flow of pressurised air to the airway of a patient at a treatment pressure according to a pre-sleep profile of pressure versus time, increase, upon detection of sleep onset of the patient, the treatment pressure to a predetermined therapeutic pressure according to a bridging profile of pressure versus time, and supply the flow of pressurised air to the airway of the patient at a therapeutic pressure.

Description

Method and device for treating respiratory disorders

The present technology relates to detecting, diagnosing, treating, preventing, and ameliorating one or more of respiratory related disorders. More specifically, the present technology relates to medical devices or devices, and their use.

Human respiratory system and its disorder

The respiratory system of the body promotes gas exchange. The nose and mouth form the patient's airway entrance.

The airway consists of a series of branching tubes that become narrower, shorter, and more as the branching tube penetrates deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood and excrete carbon dioxide from the air. The trachea is divided into right and left main bronchus and finally further divided into terminal bronchioles. The bronchi constitutes a conductive airway and does not participate in gas exchange. Further branching of the airway results in respiratory bronchioles and eventually to the alveoli. The alveolar region of the lung is where gas exchange occurs and is called the respiratory zone. See the 9th edition, published in 2011 by John B. Weiss, Lippincott Williams, and Wilkins, entitled Respiratory Physiology.

The presence of respiratory disorders

Obstructive Sleep Apnoea (OSA) is a form of Sleep Disordered Breathing (SDB) characterized by upper airway occlusion during sleep. This is the combination of normal loss of muscle tension in the upper airway and tongue area during sleep, soft palate and posterior pharyngeal wall. This symptom causes the affected patient to typically stop breathing for 30 to 120 seconds per night, sometimes 200 to 300 seconds. At this time, it often causes excessive daytime sleepiness, and may cause cardiovascular disease and brain damage. The complication is generally disordered, especially in middle-aged overweight men, although the affected person may not notice the problem. See U.S. Patent No. 4,944,310 (Sullivan).

CSR (Cheyne-Stokes Respiration) is the disorder of the respiratory organ regulation system in patients. Among them, there is a rhythm of alternating rhythm and ventilating, which causes repeated hypoxia and reoxygenation of arterial blood. Chen-Shi breathing is potentially harmful because of repetitive oxygen deficiency. In some patients, C-respiratory (CSR) is associated with repeated arousal from sleep, which causes severe sleep disintegration, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

Obesity Hyperventilation Syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia in waking, with no known factors for inadequate ventilation. Symptoms include difficulty breathing, morning headaches, and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) includes any of the low airway diseases that share specific characteristics. These include increased resistance to air flow, prolonged breathing exhalation phase, and loss of normal lung flexibility. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the main risk factor), occupational exposure, air pollution and genetic factors. Symptoms include: exercise dyspnea, chronic cough and spasm.

Neuromuscular disease (NMD) is a broad term that includes many diseases and disorders that directly impair muscle function via essential muscle pathology or indirectly via neuropathology. Some NMD patients are characterized by progressive muscle damage resulting in decreased mobility (requires wheelchair access), difficulty swallowing, respiratory muscle failure, and finally, respiratory failure leading to death. Neuromuscular disorders can be divided into rapid progressive and chronic progressive: (i) rapid progressive disorder: characterized by muscle damage worsening for more than a few months and causing death within a few years (eg, adolescent atrophic lateral sclerosis) (ALS) and Muscle's Muscular Deficiency Disorder (DMD); (ii) Variable or slow progressive disorder: characterized by muscle damage worsening for more than a few years and only slightly reducing the likelihood of life expectancy (eg, limbs) Belt type, face shoulder arm type, and myotonic muscle dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing during exercise and rest, fatigue, sleepiness, morning headaches, difficulty in concentration, and mood changes.

Thoracic wall disorders are thoracic deformations that result in inefficient coupling between respiratory muscles and the thorax. The characteristics of the thoracic wall disorder are often a limiting disorder and share the potential for long-term hypercapnia respiratory failure. Scoliosis and/or posterior curvature of the spine may cause severe respiratory failure. Symptoms of respiratory failure include: exercise dyspnea, peripheral edema, sitting breathing, periodic chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

Otherwise healthy individuals can use the system and devices to avoid breathing disorders.

treatment

Nasal Continuous Positive Airway Pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA, Obstructive Sleep Apnea). The hypothesis is that continuous positive airway pressure acts as a blown splint and can avoid upper airway obstruction by pushing and pushing the soft palate and the tongue away from the posterior pharyngeal wall.

Non-Invasive Ventilation (NIV) provides respirator support to the patient through the upper airway to assist the patient in taking complete breathing and/or by performing some or all of the breathing work to maintain proper oxygen levels in the body. Respirator support is provided through a patient interface. NIV has been used to treat CSR, OHS, COPD, NMD and thoracic wall disorders.

system

One known device for providing CPAP therapy (PAP (Passive Airway Pressure) device) is the S9 sleep therapy system, which is manufactured by ResMed Corporation. Respirator (ResMed Stellar ^TM series such as adult and pediatric respirators) may provide different non-dependent patients with non-invasive ventilation support for the different treatment conditions, such as but not limited to CSR, NMD, OHS and COPD.

A system can include a PAP device/respirator, an airway, a humidifier, a patient interface, and data management.

Patient interface

A patient interface can be used to interface the respiratory device and its user, for example by providing a flow of air. Air flow can be supplied to the nose and/or mouth through a nasal mask, to the mouth through a tube, or to the user's air tube through a gas-cut tube. The treatment to be applied, the patient interface may be formed, for example with a face seal region of the patient, to facilitate the transfer of gas with a pressure difference sufficient to exert effect of ambient pressure, e.g. about 10cmH ₂ O positive pressure. For other forms of treatment, such as oxygen delivery, the patient interface may include a sufficient seal to a positive pressure of about 10cmH ₂ O, facilitate delivery of the gas supply airway.

Breathing device (PAP device / respirator)

Examples include respiratory device ResMed 's S9 AutoSet ^TM PAP device and the ResMed' s Stellar ^TM 150 respirator. The PAP device or respirator typically includes a pressure device, such as a motor driven blower or a compressed gas reservoir, and constitutes an air supply to the patient's airway. In some cases, a positive pressure air stream may be supplied to the patient's airway. The outlet of the PAP device or respirator is connected to the patient interface through the airway, as previously described.

The present technology is directed to providing a medical device for diagnosing, ameliorating, treating, or preventing a respiratory disorder, which has one or more of improved comfort, cost, performance, ease of use, and manufacturability.

The first aspect of the technology relates to the diagnosis, improvement, treatment or prevention of call A device for sucking obstacles.

Another aspect of the present technology relates to methods for diagnosing, ameliorating, treating or preventing a respiratory disorder.

One aspect of the present technology includes a method and apparatus for treating a respiratory disorder that utilizes an initial phase of operation to allow the patient to fall asleep prior to initiating treatment, prior to delivering the therapeutic pressure. During the initial phase of the operation, the treatment pressure follows a bedtime mode that is designed to let the patient fall asleep. The treatment pressure then follows the transition mode to bring the treatment pressure to a minimum treatment pressure during which treatment can begin. Preferably, the transition from the bedtime mode to the transition mode can be caused by the detection of the beginning of sleep.

According to one aspect of the present technology, an apparatus for treating a respiratory disorder includes: a pressure device; and a controller including at least one processor. The controller is configured to: control the pressure device to supply the pressurized air to the airway of the patient under a treatment pressure according to a bedtime mode when pressure is compared with time when starting treatment; detecting the patient At the beginning of the fall of sleep, the treatment pressure is increased to a predetermined treatment pressure according to a transition mode in which the pressure is compared with time; and at a treatment pressure, the flow of the pressurized air is supplied to the airway of the patient.

According to another aspect of the present technology, a method of treating a respiratory disorder is provided. The method includes: when starting the treatment, according to a bedtime mode in which the pressure is compared with time, supplying the pressurized air to the airway of the patient under a treatment pressure; and detecting the pressure of the patient at the beginning of the sleep, according to a pressure A transition mode compared to time increases the treatment pressure to a predetermined treatment pressure; and at a treatment pressure, supplies the flow of pressurized air to the airway of the patient.

According to another aspect of the present technology, an apparatus for treating a respiratory disorder is provided. The device includes: a pressure device; and a controller including at least one processor. The controller is configured to: control the pressure device to supply the pressurized air to the airway of the patient under a treatment pressure when starting the treatment, which is started before a bedtime pressure, and according to the occurrence of a sleep disordered breathing event And changing; when detecting the start of sleep of the patient, increasing the treatment pressure to a predetermined treatment pressure according to a transition mode of pressure versus time; and supplying the pressurized air flow to the airway of the patient at a treatment pressure.

According to another aspect of the present technology, a method of treating a respiratory disorder is provided. The method includes: when the treatment is started, supplying the pressurized air to the airway of the patient under a treatment pressure, which is started before a bedtime pressure, and changes according to the occurrence of a sleep disordered breathing event; when the patient is detected At the beginning of the fall of sleep, the treatment pressure is increased to a predetermined treatment pressure according to a transition mode in which the pressure is compared with time; and at a treatment pressure, the flow of the pressurized air is supplied to the airway of the patient.

According to another aspect of the present technology, an apparatus for treating a respiratory disorder is provided. The device includes: a pressure device; and a controller including at least one processor. The controller is configured to: control the pressure device to supply the pressurized air to the airway of the patient under a treatment pressure according to a bedtime mode when pressure is compared with time when starting treatment; when detecting the patient At the beginning of the fall of sleep, the treatment pressure is adjusted according to the occurrence of a sleep disordered breathing event; and when the treatment pressure reaches a predetermined treatment pressure, the pressurized air is supplied to the airway of the patient under a treatment pressure.

According to another aspect of the present technology, a method of treating a respiratory disorder is provided. The method includes: when starting the treatment, according to a bedtime mode in which the pressure is compared with time, supplying the pressurized air to the airway of the patient under a treatment pressure; when detecting the patient's falling into sleep, according to the sleep breathing The treatment of the dysfunction event adjusts the treatment pressure; and when the treatment pressure reaches a predetermined treatment pressure, the pressurized air is supplied to the airway of the patient under a treatment pressure.

Of course, portions of the aspects may form an aspect of the technology. At the same time, various aspects of the subject matter and/or aspects may be combined in various different ways and also constitute an additional aspect or an accessory aspect of the present technology.

Other features of the present technology will become more apparent from the following description of the "embodiments", "the summary of the invention", the "simplified description of the drawings", and the "invention scope".

1000‧‧‧ patients

3000‧‧‧Full cover

3100‧‧‧ Seal forming structure

3200‧‧‧ air cavity

3300‧‧‧ structure

3400‧‧‧Ventilator

3600‧‧‧Connection port

4000‧‧‧Pneumatic Positive Pressure (PAP) devices

4010‧‧‧ Shell

4012‧‧‧Upper parts

4014‧‧‧ Lower parts

4015‧‧‧ face plate

4016‧‧‧Base

4018‧‧‧ ring handle

4020‧‧‧ pneumatic block

4100‧‧‧Pneumatic components

4110‧‧‧Air filter

4112‧‧‧Air intake filter

4114‧‧‧Air filter

4120‧‧‧Muffler

4122‧‧‧Intake silencer

4124‧‧‧Exhaust silencer

4140‧‧‧ Pressure devices

4142‧‧‧Air blower

4144‧‧‧Brushless DC Motor

4160‧‧‧Anti-backflow valve

4170‧‧‧ gas path

4180‧‧‧Supply oxygen

4200‧‧‧Electrical components

4202‧‧‧ Printed circuit board assembly

4210‧‧‧Power supply

4220‧‧‧Input device

4230‧‧‧Central controller

4232‧‧‧ clock

4240‧‧‧Treatment device controller

4245‧‧‧Treatment device

4250‧‧‧Protection circuit

4260‧‧‧ memory

4270‧‧‧ converter

4272‧‧‧pressure converter

4274‧‧‧Flow Converter

4276‧‧‧ Motor speed

4280‧‧‧Data Communication Interface

4282‧‧‧Remote external communication network

4284‧‧‧Local external communication network

4286‧‧‧ Remote external device

4288‧‧‧Local external devices

4290‧‧‧ Output device

4292‧‧‧Display Driver

4294‧‧‧ display

4300‧‧‧ algorithm

4310‧‧‧Pre-processing module

4312‧‧‧ Pressure compensation

4314‧‧‧Ventilator flow algorithm

4316‧‧‧Leakage flow algorithm

4318‧‧‧Respiratory flow algorithm

4320‧‧‧Treatment Engine Module

4321‧‧‧ phase decision algorithm

4322‧‧‧ Waveform Determination Algorithm

4323‧‧‧Ventilation Decision Algorithm

4324‧‧‧Inspiratory flow restriction decision

4325‧‧‧No breathing/low breathing decision algorithm

4326‧‧‧Nasal decision algorithm

4327‧‧‧ Airway unblocking decision algorithm

4328‧‧‧ treatment parameter decision algorithm

4330‧‧‧Control Module

4340‧‧‧ Fault Condition Module

4500‧‧‧ method

4520‧‧‧Steps

4530‧‧‧Steps

4540‧‧‧Steps

4550‧‧‧Steps

4560‧‧‧Steps

4600‧‧‧ operation

4610‧‧‧ bedtime mode

4620‧‧‧ transition period

4630‧‧‧ treatment mode

4700‧‧‧solid trace

4710‧‧‧Time

4720‧‧‧Transition mode

4730‧‧‧dotted trace

4740‧‧‧Time

4750‧‧‧Transition mode

4760‧‧‧ Traces

4770‧‧‧Time

4780‧‧‧Transition mode

4790‧‧‧ Traces

4791‧‧‧ bedtime mode

4792‧‧‧Time

4794‧‧‧Transition mode

4800‧‧‧ Traces

4810‧‧‧ Status

4820‧‧‧ Status

4830‧‧‧ Traces

4840‧‧‧ bedtime mode

4850‧‧‧Transition mode

4860‧‧‧dotted line

4870‧‧‧ Traces

4875‧‧‧Time

4880‧‧‧Time

4885‧‧‧Time

4900‧‧‧ Traces

4910‧‧‧First no breathing

4920‧‧‧Second no breathing

4930‧‧‧The third no breath

4940‧‧‧solid trace

4950‧‧‧dotted trace

4960‧‧‧Location

4970‧‧‧Location

4980‧‧‧Location

5000‧‧‧ humidifier

5110‧‧‧Sink

5120‧‧‧heating plate

5250‧‧‧ humidifier controller

The present technology is described by way of non-limiting example in conjunction with the accompanying drawings, in which

Treatment system

Figure 1a shows a system in accordance with the present technology. The patient (1000) wears a patient interface (3000) and receives a positive pressure ventilation supply from a PAP device (4000). Air from the PAP device is wetted by the humidifier (5000) and delivered to the patient (1000) along the airway (4170).

Figure 1b shows a PAP device (4000) used in a patient (1000) wearing a nasal mask (3000).

Figure 1c shows a PAP device (4000) used in a patient (1000) wearing a full face mask (3000).

Respiratory system

Figure 2a shows an overview of the human respiratory system, including the nasal cavity and mouth, throat, vocal cords, esophagus, trachea, bronchi, lung, alveolar sac, heart and diaphragm.

Figure 2b shows a pattern of airway routes on the human body, including nasal cavity, nasal bone, lateral nasal cartilage, large alar cartilage, nostril, upper lip, lower lip, throat, hard palate, soft palate, oropharynx tongue, throat cap, vocal cord, esophagus and trachea .

Patient interface

Figure 3a shows a patient interface (3000) in accordance with one form of the present technology.

PAP device

Figure 4a shows a PAP device (4000) in accordance with one form of the present technology.

Figure 4b shows a schematic diagram of the gas path of a PAP device (4000) in accordance with one form of the present technology, with the upstream and downstream directions indicated.

Figure 4c shows a schematic diagram of the electrical components of a PAP device (4000) in accordance with an aspect of the present technology.

Figure 4d shows a schematic diagram of an algorithm (4300) implemented in a PAP device (4000) in accordance with an aspect of the present technology. In this figure, the solid arrow indicates the actual flow of information, such as through an electronic signal.

Figure 4e is a illustration of the treatment via Figure 4d in accordance with an aspect of the present technology A flow chart of the method (4500) implemented by the engine module (4320).

4f is a state diagram illustrating an initial stage of operation of the treatment engine module (4320) of FIG. 4d, exemplified in accordance with an aspect of the present technology.

Figures 4g, 4h, 4i, 4j(a), 4j(b) and 4k include illustrations illustrating the initial stages of operation of the treatment engine module (4320) of Figure 4d as described with reference to Figure 4f.

41(a), 41(b) include diagrams illustrating different implementations of the treatment parameter decision algorithm (4328) implemented by the treatment engine module (4320) of FIG. 4d.

Humidifier

Figure 5a shows a humidifier (5000) in accordance with an aspect of the present technology.

Respiratory waveform

Figure 6a shows a model breathing waveform when a person is sleeping. The horizontal axis represents time and the vertical axis represents respiratory flow. Although the parameter values can be changed, typical breathing can have the following approximations: tidal volume (Vt) 0.5L; inhalation time (Ti) 1.6s (seconds); inspiratory peak flow rate (Qpeak) 0.4L/s (seconds); exhalation Time (Te) 2.4 s (seconds); exhalation peak flow (Qpeak) - 0.5 L / s (seconds). The total respiratory duration (Ttot) is approximately 4 s (seconds). A typical respiratory rate for a person is about 15 breaths per minute (BPM) and a Vent is about 7.5 L/min. A typical duty cycle (ratio of Ti to Ttot) is about 40%.

Before the present technology is described in more detail, it should be understood that the technology is not limited to the specific examples described in the specification, and the examples may vary. At the same time, it should be understood that the present invention enables The terminology used is for the purpose of describing the particular embodiments and

treatment

In one form, the present technology includes a method for treating a respiratory disorder, the method comprising an applying step of applying a positive pressure gas to an inlet of an airway of a patient (1000).

Treatment system

In one form, the present technology includes a device for treating a respiratory disorder. The device can include a PAP device (4000) for supplying pressurized air to the patient (1000) through an air delivery tube leading to the patient interface (3000).

Patient interface (3000)

The non-invasive patient interface (3000) according to one aspect of the present technology includes the following functional aspects: a seal forming structure (3100); an air chamber (3200); a positioning and stabilizing structure (3300); and a connection port ( 3600) for connecting the gas path (4170). In some forms, a functional aspect may be provided by one or more physical components. In some forms, a physical component can provide one or more functional aspects. In use, the seal-forming structure (3100) is disposed at the inlet of the airway surrounding the patient to facilitate supply of positive pressure air to the airway.

PAP device (4000)

It should be understood that the PAP device (4000) is described below only as one form of breathing apparatus. Moreover, it will be appreciated by those skilled in the art that aspects of the present technology are applicable to other forms of breathing apparatus, such as a respirator.

A PAP device (4000) according to one aspect of the present technology includes a mechanical and pneumatic component (4100), an electrical component (4200), and is programmed to perform one or more algorithms (4300). The PAP device (4000) preferably has a housing (4010) which is preferably formed using two components, an upper member (4012) of the housing (4010) and a lower member (4014) of the housing (4010). In an alternative form, the outer casing (4010) can include one or more face plates (4015). In one form, the PAP device (4000) includes a base (4016) for supporting one or more internal components of the PAP device (4000). In one form, a pneumatic block (4020) is supported by, or forms part of, the base (4016). The PAP device (4000) can include a ring handle (4018).

The pneumatic path of the PAP device (4000) preferably includes: an intake filter (4112); an intake silencer (4122); and a controllable pressure device (4140) for supplying positive pressure air (preferably a drum) Air machine (4142)); and an air outlet silencer (4124). One or more sensors or transducers (4270) are included in the aerodynamic path.

The optimal pneumatic block (4020) includes a portion of the aerodynamic path located within the outer casing (4010).

Preferably, the PAP device (4000) has a power supply (4210), one or more input devices (4220), a central controller (4230), a treatment device controller (4240), a treatment device (4245), and a Or multiple protection circuits (4250), memory (4260), converter (4270), data communication interface (4280) and one or more outputters Piece (4290). The electrical component (4200) can be mounted on a Printed Circuit Board Assembly (PCBA) (4202). In an alternative form, the PAP device (4000) can include more than one single printed circuit board assembly (4202).

PAP device mechanical and pneumatic components (4100)

Air filter (4110)

A PAP device in accordance with one form of the present technology can include an air cleaner (4110), or a plurality of air filters (4110).

In one form, an air intake filter (4112) is disposed at the beginning of the upstream of the pneumatic path of a pressure device (4140).

In one form, an air outlet filter (4114) (e.g., an antimicrobial filter) is disposed between an outlet of the pneumatic block (4020) and a patient interface (3000).

Silencer (4120)

In one form of the present technology, an intake silencer (4122) is disposed upstream of the pneumatic path of a pressure device (4140).

In one form of the present technology, an air outlet silencer (4124) is disposed in a pneumatic path between the pressure device (4140) and a patient interface (3000).

Pressure device (4140)

In a preferred form of the present technology, a pressure device (4140) for generating a positive pressure air flow is a controllable air blower (4142). For example, the air blower can include a brushless direct current (DC) motor (4144) having one or more impellers housed within the volute. The air blower preferably delivers an air supply, for example, at a positive pressure ranging from about 4 cm H ₂ O to about 20 cm H ₂ O, about 120 liters/minute; or in other forms, up to about 30 cm H ₂ O.

The pressure device (4140) is under the control of the treatment device controller (4240).

Converter (4270)

In one form of the present technology, one or more converters (4270) are disposed upstream of the pressure device (4140). One or more converters (4270) are constructed and configured to measure air characteristics at a point in the pneumatic path.

In one form of the present technology, one or more converters (4270) are disposed downstream of the pressure device (4140) and upstream of the gas path (4170). One or more converters (4270) are constructed and configured to measure air characteristics at a point in the pneumatic path.

In one form of the present technology, one or more transducers (4270) are placed adjacent to the patient interface (3000).

Backflow prevention valve (4160)

In one form of the present technology, a backflow prevention valve is disposed between the humidifier (5000) and the pneumatic block (4020). The backflow prevention valve is constructed and arranged to reduce the risk of water flowing from upstream of the humidifier (5000) to, for example, the motor (4144).

Gas path (4170)

A pneumatic circuit (4170) in accordance with one aspect of the present technology is constructed and configured to allow air to flow between the pneumatic mass (4020) and the patient interface (3000).

Supplemental oxygen (4180) delivery

In one form of the present technology, supplemental oxygen (4180) is delivered to a point in the aerodynamic path.

In one form of the present technology, supplemental oxygen (4180) is delivered upstream of the pneumatic block (4020).

In one form of the present technology, supplemental oxygen (4180) is delivered to the gas path (4170).

In one form of the present technology, supplemental oxygen (4180) is delivered to the patient interface (3000).

PAP device electrical components (4200)

Power supply (4210)

In one form of the present technology, the power supply (4210) is the interior of the housing (4010) of the PAP device (4000). In another form of the present technology, the power supply (4210) is external to the outer casing (4010) of the PAP device (4000).

In one form of the present technology, the power supply (4210) provides only power to the PAP device (4000). In another form of the present technology, the power supply (4210) provides power to both the PAP device (4000) and the humidifier (5000).

Input device (4220)

In one form of the present technology, a PAP device (4000) includes one or more input devices (4220) in the form of buttons, switches or rotating disks that allow personnel to interact with the device. A button, switch or rotating disk can be a physical device, or a software device, that is accessed via a touch screen. In one form, the button, switch or rotating disk can be physically connected to the housing (4010); or in another form, can be in wireless communication with a receiver electrically coupled to the central controller (4230).

In one form, the input device (4220) can be constructed and configured to allow a person to select a value and/or a function menu option.

Central controller (4230)

In one form of the present technology, the central controller (4230) is a processor suitable for controlling the PAP device (4000), such as an x86 INTEL processor.

A processor (4230) suitable for controlling a PAP device (4000) in accordance with another form of the present technology includes a processor based on an ARM Cortex-M processor from ARM Holdings. For example, an STM32 series microcontroller from ST MICROELECTRONICS can be used.

Another processor (4230) suitable for controlling a PAP device (4000) in accordance with a further alternative form of the present technology includes a component selected from the family of ARM9-based 32-bit RISC CPUs. For example, an STR9 series microcontroller from ST MICROELECTRONICS can be used.

In a particular alternative form of the technology, a 16-bit RISC CPU can be used as a processor (4230) for the PAP device (4000). For example, a processor from the MSP430 series of microcontrollers manufactured by TEXAS INSTRUMENTS can be used.

The processor (4230) can be configured to receive input signals from one or more converters (4270), and one or more input devices (4220).

The processor (4230) can constitute one or more of providing an output signal to an output device (4290), a therapy device controller (4240), a data communication interface (4280), and a humidifier controller (5250).

In some forms of the present technology, the processor (4230), or multiple such processors, constitute one or more methods of implementing the specification, such as one or more algorithms (4300), which are stored for non-transient A computer program representation of a computer readable storage medium, such as a memory (4260). In some cases, as previously discussed, this processor can be integrated with a PAP device (4000). However, in some forms of the present technology, the processor can be implemented separately from the pneumatic components of the PAP device (4000), such as for performing any of the methods discussed herein without the need to directly control the delivery of respiratory therapy. For example, to decide on a respirator or other breathing related things For the purpose of controlling setpoints, the processor can perform any of the methods discussed herein by analyzing data stored by any of the sensors, such as those discussed in this specification.

The central controller (4230) of the PAP device (4000) is programmed to execute one or more algorithm (4300) modules, preferably including a pre-processing module (4310), a therapy engine module (4320), A treatment control module (4330), and a fault condition module (4340).

Clock (4232)

Preferably, the PAP device (4000) includes a clock (4232) coupled to the processor (4230).

Therapeutic Device Controller (4240)

In one form of the present technology, the treatment device controller (4240) is configured to control the treatment device (4245) to deliver therapy to the patient (1000).

In one form of the present technology, the treatment device controller (4240) is a treatment control module (4330) that forms part of the algorithm (4300) performed by the processor (4230).

In one form of the present technology, the treatment device controller (4240) is a dedicated motor control integrated circuit. For example, in one form, an MC33035 brushless direct current (DC) motor controller manufactured by ONSEMI can be used.

Therapeutic device (4245)

In one form of the present technology, the treatment device (4245) is configured to deliver therapy to the patient (1000) under the control of the treatment device controller (4240).

Preferably, the therapeutic device (4245) is a pressure device (4140).

Protection circuit (4250)

Preferably, the PAP device (4000) according to the present technology includes one or more protection circuits (4250).

One of the protection circuits (4250) according to the present technology is in the form of an electrical protection circuit.

One form of the protection circuit (4250) according to the present technology is a temperature or pressure safety circuit.

Memory (4260)

In accordance with one form of the present technology, the PAP device (4000) includes a memory (4260), preferably a non-volatile memory. In some forms, the memory (4260) can include a battery powered static RAM memory. In some forms, the memory (4260) can include a volatile RAM memory.

Preferably, the memory (4260) is disposed on the PCBA printed circuit board assembly (4202). The memory (4260) can be in the form of an EEPROM, or NAND flash memory unit.

Additionally or alternatively, the PAP device (4000) includes a removable memory (4260), such as a memory card manufactured in accordance with the Secure Digital (SD) standard.

In one form of the present technology, the memory (4260) acts as a non-transitory computer readable storage medium storing computer program instructions, such as one or more algorithms (4300), representing one or more of the methods described in this specification. ).

Converter (4270)

The converter can be internal to the PAP device (4000) or external to the PAP device (4000). The external transducer can be disposed, for example, in a portion or form of the gas delivery path (4170), such as at the patient interface (3000). The external converter can be in the form of a contactless sensor, such as a Doppler radar motion sensor, that can transmit or transfer data to the PAP device (4000).

Flow converter (4274)

A flow converter (4274) according to one of the present techniques can be based on a differential pressure converter, such as the SDP600 series of differential pressure converters from SENSIRION Corporation. The differential pressure converter is in fluid communication with each of the pneumatic circuit and the pressure transducer, the pressure transducers being coupled to respective first and second points of a flow restriction element.

In one example, a signal from one of the flow converters (4274) representing the total flow Qt is received by the processor (4230).

Pressure transducer (4272)

A pressure transducer (4272) in accordance with the present technology is configured to be in fluid communication with a pneumatic path. An example of a suitable pressure transducer (4272) is a sensor from the HONEYWELL ASDX series. An alternative suitable pressure transducer is one of the NPA series sensors from GENERAL ELECTRIC.

In use, the signal from the pressure transducer (4272) is received by the processor (4230). In one form, the signal is first filtered before the processor (4230) receives the signal from the pressure transducer (4272).

Motor speed (4276)

In one form of the present technology, a motor speed (4276) is generated. A motor speed signal (4276) is preferably provided by the treatment device controller (4240). The motor speed can be generated, for example, by a speed sensor, such as a Hall effect sensor.

Data Communication Interface (4280)

In a preferred form of the present technology, a data communication interface (4280) is provided and coupled to the processor (4230). The data communication interface (4280) is preferably connected to a remote external communication network (4282). Data communication interface (4280) is best connected to local external communication News Network (4284). Preferably, the remote external communication network (4282) can be connected to a remote external device (4286). Preferably, the local external communication network (4284) can be connected to a local external device (4288).

In one form, the data communication interface (4280) is part of the processor (4230). In another form, the data communication interface (4280) is an integrated circuit that is separate from the processor (4230).

In one form, the remote external communication network (4282) is the Internet. The data communication interface (4280) can be connected to the Internet using wired communication (eg, via Ethernet, or fiber optics) or a wireless protocol.

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

In one form, the remote external device (4286) is one or more computers, such as a network of computer connected networks. In one form, the remote external device (4286) can be a virtual computer, not a physical computer. In either case, the remote external device (4286) can be accessed by a suitably legitimate person, such as a clinician.

Preferably, the local external device (4288) is a personal computer, mobile phone, tablet or remote control.

Output device including selective display and alarm (4290)

The output device (4290) according to one of the techniques can be visual, audio and tactile The form of one or more of the units. A visual display can be a liquid crystal display (LCD) or a light emitting diode (LED) display.

Display driver (4292)

A display driver (4292) receives a character, symbol, or image as an input for display on the display (4294) and converts it into a command to cause the display (4294) to display such characters, symbols, or images. .

Display (4294)

A display (4294) constitutes a visual display character, symbol or image in response to commands received from the display driver (4292). For example, the display (4294) can be an eight-segment display, in this case the display driver (4292) converts each character or symbol (such as the number "0") into eight logic signals to indicate whether to motivate eight individual segments. To display special characters or symbols.

PAP device algorithm (4300)

Pre-processing module (4310)

A pre-processing module (4310) according to the present technology receives raw data as input from a converter (eg, a flow or pressure transducer), and preferably performs one or more processing steps to calculate one or Multiple output values are used as input to another module, such as a therapy engine module (4320).

In one form of the present technology, the output value includes interface or hood pressure Pm , respiratory flow rate Qr , and leakage flow rate Q1 .

In various forms of the present technology, the pre-processing module (4310) includes one or more of the following algorithms: pressure compensation (4312), vent flow (4314), leakage flow (4316), and respiratory flow (4318). ).

Pressure compensation (4312)

In one form of the present technique, a pressure compensation algorithm (4312) receives a signal as an input to indicate the pressure of the pneumatic mass (4020) near the exit of the pneumatic path. The pressure compensation algorithm (4312) evaluates the pressure drop at the gas path (4170) and provides an estimated pressure Pm as an output at the patient interface (3000).

Ventilation port flow (4314)

In one form of the present technology, a venting port flow calculation algorithm (4314) receives an estimated pressure Pm as input at the patient interface (3000) and an estimated ventilator (3400) at the patient interface (3000). ) Ventilation port air flow Qv .

Leakage flow (4316)

In one form of the present technology, a leakage flow algorithm (4316) receives a total flow Qt as an input, and a vent flow Qv , and calculates an average of Qt-Qv over a sufficiently long period of time to include A number of breathing cycles (e.g., about 10 seconds) are provided to provide a leakage flow Q1 as an output.

In one form, the leakage flow algorithm (4316) receives the patient interface (3000) as an input of a total flow rate Qt , a venting port flow Qv , and an estimated pressure Pm , and by calculating a leakage conductance, and determining A leakage flow rate Q1 and a hood pressure Pm of the leakage conductance function are provided as a leakage flow rate Q1 as an output. Preferably, the leakage conductance is calculated by a quotient of the low pass filtering non-venting port flow rate Qt-Qv and a low pass filtering square root of the hood pressure Pm , wherein the low pass filtering time constant has a sufficiently long value to include the number One breathing cycle, for example about 10 seconds.

Respiratory flow (4318)

In one form of the present technology, a respiratory flow algorithm (4318) receives a total flow Qt as input, a vent flow Qv , and a leakage flow Q1 , and subtracts ventilation from the total flow Qt. The mouth flow Qv and the leak flow Q1 are used to estimate the patient's breathing air flow Qr .

Treatment Engine Module (4320)

In one form of the present technology, a treatment engine module (4320) receives one or more of a pressure Pm as an input at the patient interface (3000), and a respiratory air flow Qr of the patient, and provides one or as an output. Multiple treatment parameters.

In various forms, the treatment engine module (4320) includes one or more of the following algorithms: phase determination (4321), waveform determination (4322), ventilation decision (4323), inspiratory flow limitation decision (4324). No breathing/low breathing decision (4325), The sinus is determined (4326), the airway is unblocked (4327), and the treatment parameters are determined (4328).

Phase decision (4321)

In one form of the present technique, a phase decision algorithm (4321) receives a respiratory flow Qr signal indication as an input and provides a respiratory cycle phase of a patient (1000) as an output.

In one form, the phase output is a discontinuous variable having an inhalation or expiratory value. In this form of implementation, when the respiratory flow Qr has a positive value that exceeds a positive threshold, the phase output is determined to have a discontinuous value of inhalation, and when the respiratory flow Qr has a lower negative value than a negative threshold, It is determined that the phase has a discontinuous value of exhalation.

In one form, the phase output is a discontinuous variable having a value of either inhalation, mid-inhalation pause, and exhalation.

In one form, the phase output is a continuous variable, such as a change from 0 to 1, or 0 to 2 radians.

Waveform decision (4322)

In one form of the present technology, a control module (4330) controls a treatment device (4245) to provide a near steady positive airway pressure during the patient's breathing cycle.

In one form of the present technology, a control module (4330) controls a therapeutic device (4245), providing a positive airway pressure based on a predetermined waveform compared to a phase of pressure versus phase. In one form, the waveform maintains an approximately stable level for all values of the phase. In one form, the waveform is a square wave that has a higher value for some phase values and a lower level for other phase values.

In one form of the present technique, a waveform decision algorithm (4322) receives a value as an input for indicating the current patient ventilation Vent and provides a pressure versus phase comparison waveform as an output.

Ventilation decision (4323)

In one form of the present technique, a ventilation decision algorithm (4323) receives a respiratory flow Qr as an input and determines a measurement indicative of the patient's ventilation Vent.

In one form, the ventilation decision algorithm (4323) determines the current value Vent of the patient's ventilation, which is half the absolute value of the low-pass filtering of the respiratory flow Qr .

Inspiratory flow restriction decision (4324)

In one form of the present technology, a processor executes one or more algorithms for detecting inspiratory flow limits (4324).

In one form, the algorithm (4324) receives a respiratory flow signal Qr as an input and provides a measure of the extent to which the inspiratory portion of the breath as an output exhibits an inspiratory flow restriction.

In one form of the present technology, the inspiratory portion of each breath is identified by a zero crossing detector. The number of average spaced points (e.g., 65) representing the point in time can be inserted by the inserter along the inspiratory flow-time curve for each breath. The curve described by the point is then scaled via a scale to have a unit length (duration/period) and unit area to remove the effect of changing the respiration rate and depth. A comparator then compares the calibrated breath to a pre-stored sample representative of normal unobstructed breathing, similar to the inspiratory portion of the breath shown in Figure 6a. At any time during inhalation from this template (such as due to coughing, sighing, swallowing, and snoring), breathing that deviates from a specified threshold (typically 1 scale unit) as determined by the test element can be Refuse. For non-rejected data, the processor (4230) can calculate a moving average of the first of the calibration points of the aforementioned plurality of inhalation events. This can be repeated at the second inspiratory event at this point, and so on. Thus, for example, the processor (4230) can generate 65 calibration data points and represent a moving average of the aforementioned inhalation events, such as 3 events. The moving average of the continuously updated values of these points is hereinafter referred to as "calibrated flow" and is expressed as Qs(t) . Alternatively, a single inhalation event can be used instead of a moving average.

From the calibration flow, two shape factors can be calculated regarding the decision of local blockage.

Shape factor 1 is the ratio of the average of the intermediate (eg, 32) calibrated flow points to the average of all (eg, 65) calibrated flow points. In the case where the ratio exceeds the unit (Unity), breathing will be considered normal. In the case of Unity or smaller, breathing will be considered blocked. A ratio of about 1.17 is used as a threshold between local obstructive and obstructive respiration, and is equivalent to allowing the degree of obstruction of proper oxygen to be maintained in a typical user.

The shape factor 2 is calculated as the RMS deviating from the unit calibration flow, using an intermediate (eg, 32) point. An RMS deviation of about 0.2 units is considered normal. Zero RMS deviation is considered as total flow limit breathing. The RMS deviation is closer to zero and the breath will be considered a larger flow limit.

Shape factors 1 and 2 can be used alternatively or in combination. In other forms of the technology, the number of sampling points, breaths, and intermediate points may differ from those described above. Further, the threshold may be a value other than such a description.

No breathing and low breathing decisions (4325)

In one form of the present technology, a processor (4230) performs one or more algorithms (4325) for determining whether apnea and/or low breathing occurs.

Preferably, one or more algorithms (4325) receive a respiratory flow signal Qr as an input and provide a flag as an output indicating whether no breathing or low breathing has been found.

In one form, when the function of the respiratory flow rate Qr falls below the flow threshold for a predetermined period of time, it can be said that no breathing has been detected. The function may determine a peak flow, a relatively short-term average flow, or an intermediate flow of a relatively short-term average and peak flow, such as RMS flow. The flow threshold can be a relatively long-term measurement of the flow.

In one form, when the function of the respiratory flow rate Qr falls below a second flow rate threshold for a predetermined period of time, it can be said that low breathing has been detected. The function may determine a peak flow, a relatively short-term average flow, or an intermediate flow of a relatively short-term average and peak flow, such as RMS flow. The second flow threshold can be a relatively long-term measurement of the flow. The second flow threshold is greater than the threshold for detecting apnea.

Boo determination (4326)

In one form of the present technology, a processor (4230) performs one or more nasal algorithms (4326) for detecting nasal discharge.

In one form, the snivel algorithm (4326) receives a respiratory flow signal Qr as an input and provides a measure of the extent to which the snot appears as an output.

Preferably, the algorithm (4326) includes the step of determining the strength of the flow signal in the range of 30-300 Hz. Further preferably, the algorithm (4326) includes the step of filtering the respiratory flow signal Qr to reduce background noise, such as airflow sounds from a system of an air compressor.

Airway unblocked (4327)

In one form of the present technology, a processor (4230) performs one or more algorithms (4327) for determining airway patency.

In one form, the airway smoothing algorithm (4327) receives a respiratory flow signal Qr as an input and determines signal power in the frequency range of about 0.75 Hz and about 3 Hz. The peaks presented in this frequency range are used to represent an open airway. No peaks are present to indicate a closed airway.

In one form, the frequency range in which the peak is sought is the frequency of the minimum forced oscillation of the treatment pressure Pt. In one implementation, the forced oscillation is a frequency of 2 Hz having an amplitude of about 1 cm H ₂ O.

In one form, the airway smoothing algorithm (4327) receives a respiratory flow signal Qr as an input and determines whether to present a cardiogenic signal. No cardiogenic signals are present to indicate a closed airway.

Treatment parameter decision (4328)

In one form of the present technology, the processor (4230) uses the values returned by one or more of the other algorithms in the treatment engine module (4320) to perform one for determining one or more treatment parameters. Or multiple algorithms (4328).

In one form of the present technology, the treatment parameter is the instantaneous treatment pressure Pt. In one implementation of this form, the treatment pressure Pt is as follows: Pt = AP (Φ) + P ₀ (1)

Where: ‧ A is the pressure support ‧ P (Φ) is the waveform value of the current value of the phase (in the range 0 to 1); and ‧ Po is the bottom pressure

The treatment pressure Pt determined according to equation (1) can be defined as "treatment pressure." Various treatment modes can be defined based on the parameters A and Po values. In some implementations of this form of the present technology, the pressure support A is equivalent to zero, so the treatment pressure Pt is equivalent to the bottom pressure Po throughout the respiratory cycle. This implementation is usually classified under the heading of CPAP treatment.

The bottom pressure Po can be a constant value that can be specified and/or manually entered into the PAP device (4000). This alternative is sometimes referred to as continuous CPAP therapy. Alternatively, the bottom pressure Po can be an indicator of one or more of sleep disordered breathing events (eg, flow restriction, no breathing, low breathing, smoothness, and snoring) returned by the individual algorithms of the treatment engine module (4320). Or a continuous function of the measured function. This alternative is sometimes referred to as APAP treatment.

4e is a flow chart illustrating a method (4500) implemented by the processor (4230) to continuously calculate the bottom pressure Po as part of the APAP treatment implementation of the algorithm (4328). In this implementation, the therapeutic pressure Pt is equivalent to the bottom surface pressure Po by equation (1).

The method (4500) begins at step (4520), wherein the processor (4230) compares the measured value of the non-breath/low breathing occurrence with a first threshold value and determines whether the measured value of the no-breath/low-breath occurrence is A predetermined period of time has exceeded the first threshold to indicate that no breathing/low breathing is occurring. If so, the method (4500) performs step (4540); otherwise, the method (4500) performs step (4530). At step (4540), the processor (4230) compares the airway unobstructed measurement to a second threshold. If the measured value of the airway is clear beyond the second threshold, the airway is open, the found no-breath/low-breath is central, and the method (4500) performs the step (4560); otherwise, the no-breath/low-breath is obstructive And the method (4500) performs the step (4550).

At step (4530), the processor (4230) compares the measured value of the flow limit with a third threshold. If the measured value of the flow restriction exceeds the third critical value, indicating that the inspiratory flow rate is limited, the method (4500) performs the step (4550); otherwise, the method (4500) performs the step (4560).

At step (4550), the processor (4230) increases the bottom pressure Po at a predetermined pressure increment P such that the resulting treatment pressure Pt is no greater than an upper limit APAP pressure Pupper, which may be set to a specified maximum treatment pressure Pmax . In one embodiment, the predetermined pressure increment P and the maximum therapeutic pressure Pmax are 1cmH ₂ O and 25cmH ₂ O. In other implementations, the pressure increase P can be as low as 0.1 cm H ₂ O and as high as 3 cm H ₂ O, or as low as 0.5 cm H ₂ O and as high as ₂ cm H ₂ O. In other implementations, the maximum therapeutic cmH ₂ O pressure Pmax can be as low as 15 cm H ₂ O and as high as 35 cm H ₂ O, or as low as 20 cm H ₂ O and as high as 30 cm H ₂ O. The method (4500) then returns to step (4520).

At step (4560), the processor (4230) reduces the bottom pressure Po by a reduction such that the resulting treatment pressure Pt is not lower than the lower limit APAP pressure Plower , which may be set to a prescribed minimum treatment pressure Pmin . The method (4500) then returns to step (4520). In one implementation, the reduction is proportional to the Pt-Pmin value such that the Pt is reduced exponentially to a minimum treatment pressure Pmin without any event of discovery. In one embodiment, the ratio is set constant, so that the reduction of Pt exponential time constant of 60 minutes, and the minimum pressure Pmin treatment is 4cmH ₂ O. In other implementations, the time constant can be as low as 1 minute and as high as 300 minutes, or as low as 5 minutes and as high as 180 minutes. In other implementations, the minimum treatment pressure Pmin can be as low as 0 cm H ₂ O and as high as 8 cm H ₂ O, or as low as ₂ cm H ₂ O and as high as 6 cm H ₂ O. Alternatively, the reduction in the bottom surface pressure PO can be predetermined, and Pt is reduced to a minimum treatment pressure Pmin linearly without any event.

In one form of the present technology, the predetermined pressure increment P is less than the previous implementation of algorithm (4328) and the time constant is longer than its previous implementation. Such differences in actual combined flow limitation, non-breathing, low breathing, unobstructed, and nasal measurements are in a single breath assessment rather than multiple breaths, combined with a control loop implemented in this form of method (4500) of the present technology. The previous implementation of the road providing algorithm (4328) is smoother and has no "aggressive" characteristics.

Initial stage of operation

The above treatment mode is designed to be communicated to a sleeping patient (1000). However, if the patient (1000) is the start of treatment, the patient (1000) is usually awake. Once the patient (1000) begins treatment (such as when the patient goes to bed at night or returns to treatment after a midnight sleep disruption), if the PAP device (4000) begins to deliver treatment pressure, as described above, the patient (1000) may find that even if initialized to a minimum The treatment pressure Pmin , the treatment pressure Pt may be too high for the patient to fall asleep, so the purpose of treatment may be ridiculous.

Therefore, the PAP device (4000) is required to be able to operate in a "sleep mode" implemented by a processor, such as a processor of a central controller (4230). The bedtime mode can be awakened when the patient (1000) begins treatment and ends treatment at an appropriate time, such as when the PAP device (4000) considers that the patient (1000) is asleep, and/or has passed a predetermined time limit. The purpose of the bedtime mode operation is to allow the patient (1000) to fall asleep under lower or more comfortable pressure because the patient (1000) does not require treatment when awake. The treatment pressure during the bedtime mode may be a secondary treatment and follows a bedtime mode of pressure versus time, starting from the bedtime pressure Ps , which may be less than or even substantially below the minimum treatment pressure Pmin . The bedtime mode selection should be consistent with the patient's sleep. The pre-sleep pressure Ps can range from 2 to 6 cm H ₂ O, or from 3 to 5 cm H ₂ O, preferably about 4 cm H ₂ O.

After ending the bedtime mode, a "transition period" implemented by a processor, such as a processor of the central controller (4230), may be required. During this transition, the PAP device (4000) can switch between the pre-sleep mode of operation and its selected treatment mode. During this transition, the treatment pressure follows a transitional pattern of pressure versus time. The transition mode is selected to increase the therapeutic pressure Pt from a value at the beginning of the transition period to a predetermined therapeutic pressure Pth with a minimum delay, but without waking up the patient, such that the PAP device (4000) can enter the treatment mode while delivering the treatment pressure. For example, if the treatment mode is APAP treatment, the treatment pressure Pth can be the prescribed minimum treatment pressure Pmin . In other treatment modes (eg, stable CPAP), the treatment pressure Pth can be a prescribed sustained pressure.

In some implementations of the initial mode of operation, either or both of the bedtime mode and the transition mode may be defined as a functional form that controls the parameters determined by the individual parameters instantiated by the individual function functional form. The functional form may include a linear mode, an exponential mode, and a polynomial mode, or a combination thereof. Examples of parameters may include an index, a time constant, a duration, a slope, a coefficient, or a combination thereof. In some such implementations, either or both of the bedtime mode and the transition mode may determine parameters by controlling time parameters of the duration of the bedtime and transition modes. In an example, the bedtime mode is illustrated as follows:

Where ps is the bedtime parameter of the time of use. According to equation (2), the bedtime mode is a linear increment of the bedtime time parameter ps from the bedtime pressure Ps to the treatment pressure Pth . The transition time parameter can be selected to be substantially shorter than the bedtime parameter. The bedtime parameters can range from 20 to 50 minutes, or 25 to 45 minutes, or 30 to 40 minutes. The transition time parameter can range from 1 to 5 minutes, or 2 to 4 minutes, or 2.5 to 3.5 minutes. In the present specification, "substantially shorter" means shorter than a ratio between 5 and 50, or 10 and 40, or 20 and 30.

In other such implementations, either or both of the bedtime mode and the transition mode may determine the parameter by a slope value (pressure vs. time). In an example, the bedtime mode is illustrated as follows: Pt ( t ) = Ps + △ _ps t (3)

Where ps is the bedtime slope parameter. According to equation (3), the bedtime mode is a linear increment of the pre-sleep pressure ps from the bedtime pressure Ps.

In this implementation, the transition slope parameter may be selected to be substantially higher than the bedtime slope parameter. The bedtime slope parameter can range from 0.1 to 0.5 cm H ₂ O/min, or 0.2 to 0.4 cm H ₂ O/min, or 0.25 to 0.35 cm H ₂ O/min. Transition Time may range from 0.5 to 10cmH ₂ O / min, or from 2 to 8cmH ₂ O / min or 3 to 6cmH ₂ O / min. In the present specification, "substantially higher" means higher at a ratio between 5 and 50, or 10 and 40, or 20 and 30. In this implementation, the transition slope parameter is set to a predetermined maximum rate of increase in treatment pressure, known as the maximum upward rate of rotation. The maximum upward slew rate can be as high as 0.25 cmH ₂ O/sec.

Figure 4f is a state diagram illustrating the initial stages of operation (4600) of the treatment engine module (4320) in one form of the present technology. According to the initial phase of operation (4600), when the patient (1000) begins treatment, the PAP device (4000) enters bedtime mode (4610). In one implementation, an initial signal is generated, i.e., a treatment initiation signal input by the patient (1000) through the input device (4220) into the PAP device (4000). In another implementation, the start signal is detected by the processor (4230) in response to the ventilation decision algorithm (4323) detecting that the patient (1000) has begun to wear the patient interface (3000) and/or is generating a SmartStart signal. . This detection can be achieved by the processor (4230) in a conventional manner, such as the disclosure of the "Continuous Positive Airway Pressure Breathing (CPAP) Device" of European Patent Application No. EP 661,071, to ResMed Limited. During the bedtime mode (4610), the processor (4230) initializes the treatment pressure Pt to the bedtime pressure Ps. The processor then controls the treatment pressure Pt pressure according to the bedtime mode.

During the bedtime mode (4610), the processor (4230) may monitor the respiratory flow Qr or other sensor signal processing to detect the onset of sleep. The onset of sleep can be detected by any conventional method determined by the immediate sleep state. In one implementation, if one or both of the following conditions occur, the sleep begins to be discovered:

• SDB events occur multiple times during a first predetermined interval, such as flow restriction, no breathing, low breathing, or nasal discharge, as determined by measuring these amounts obtained above. For example, there are three or more obstructive no-breathing or low-breathing events in a two-minute interval; or five nasal sputum exemplifications in five breathing intervals.

‧ There is little or no breathing disorder at a second predetermined interval. The second predetermined interval may be in the range of 10 to 50 breaths, or 20 to 40 breaths, or 25 to 35 breaths, or from 1 to 10 minutes, 1 to 5 minutes; or 2, 3, 4, 5, 6, 7, 8 or 9 minutes, or some other time limit. To detect no breathing disorder, the controller (4230) tests for a lack of ventilation at a second predetermined interval of one or more of the following respiratory variables: o tidal volume; o inhalation time; o respiration rate; o inspiratory peak flow rate ;o exhalation peak flow position; o time since the last breath.

If a sleep falls, and/or a timer reaches a timer limit (such as a timer limit, which is a function of the bedtime parameter), the PAP device (4000) transitions from bedtime mode (4610) to transition period (4620). ). In one implementation, the PAP device (4000) does not constitute a detection of whether sleep has begun to occur, and transitioning from the set mode (4610) to the transition period (4620) is based on whether a timer reaches the timer limit or any other suitable component. In one implementation, the timer limit is equal to the bedtime time parameter. In another implementation, the timer limit is equal to the difference between the treatment pressure Pth and the bedtime pressure Ps divided by the bedtime slope parameter.

During the transition period (4620), the processor (4230) increases the value of the treatment pressure Pt from the transition period (4620) to the treatment pressure Pth according to the transition mode.

Once the treatment pressure reaches the treatment pressure Pth, the PAP device (4000) then transitions from the transition period (4620) to the treatment mode (4630). In the treatment mode (4630), the PAP device (4000) can be delivered according to equation (1) in the current mode of treatment. The pressurized air is treated, for example, by using the above method (4500) to perform APAP treatment.

Note that the transition period (4620) may be zero duration if the treatment pressure Pt has reached or has reached the treatment pressure Pth before or after the timer limit expires. In this case, there is no pressure change during the transition period (4620) and the PAP device immediately enters the treatment mode (4630).

In one implementation, the bedtime mode is a linear increment from the pre-sleep pressure Ps to the treatment pressure Pth (see Figure 4j(b)). The slope of the linear increment can be the pre-sleep slope, as in equation (3), or can be selected such that the treatment pressure is not found at the beginning of sleep, reaching the treatment pressure Pth at the bedtime parameter, as in equation (2). In another implementation, the bedtime mode is an exponential increase from pre-sleep pressure Ps to treatment pressure Pth . The exponential increase can have a time constant equal to the bedtime parameter. In another implementation, the bedtime mode is equal to the duration of the bedtime time parameter equal to the continuous pressure of the bedtime pressure Ps (see Figures 4g and 4h). In still another implementation, the bedtime mode is a series of linear increments separated by a "pause period" during the period of constant treatment pressure (see Figure 4i). When the PAP device (4000) is still in bedtime mode (4610), the pause period allows the patient (1000) to apply a comfortable method to accommodate each pressure increment. The linear incremental slope and duration, and the duration of the pause period are selectable such that the treatment pressure reaches the treatment pressure Pth at the bedtime parameter without beginning to fall asleep. Alternatively, the slope of the linear increment may be equal to the bedtime slope parameter, and the duration of the linear increment and the pause period duration may be predetermined. When it is found that sleep falls, the duration of the pause period decreases during the transition period (4620), as described below (see Figure 4i). In still another implementation, the bedtime mode is a series of linear increments that match the inspiratory portion of each breathing cycle separated by a "pause period" that meets the exhalation of each breathing cycle while the treatment pressure remains constant. section. The inspiratory and expiratory portions of each inspiratory cycle are detected by a phase determination algorithm (4321). The slope of the linear increment can be equal to the bedtime slope parameter. In addition to the above, other bedtime modes can be considered.

In one implementation, the transition mode is a linear increment of the treatment pressure Pth . The slope of the linear increment can be a transition slope parameter, or can be selected such that the treatment pressure reaches the treatment pressure Pth at this transition time parameter (see Figure 4g). In another implementation, the transition mode is a series of linear increments separated by a pause period during the period of constant treatment pressure. The slope and duration of the linear increment can be the same as the corresponding implementation of the bedtime mode (4610). However, the pause period duration may be selected such that the treatment pressure reaches the treatment pressure Pth at the transition time parameter (see Figure 4i). The pause period duration can be zero seconds, which makes the transition mode equivalent to a continuous linear increment. In still another implementation, the transition mode is a series of linear increments that conform to the inspiratory portion of each breathing cycle separated by a pause period that matches the expiratory portion of each breathing cycle (see Figure 4h). . The slope of the linear increment can be equal to the slope of the transition slope before going to bed. In addition to the above, other transition modes can be considered.

During the initial phase of operation (4600), the treatment pressure Pt during the bedtime mode (4610) does not follow a predetermined pressure time mode, but is automatically adjusted in the "soft APAP" mode. In soft APAP mode, the treatment control module (4320) delivers APAP therapy to the patient (1000), for example by performing method (4500) (see Figure 4e), the treatment pressure Pt is initialized to bed pressure Ps . The lower limit APAP pressure Plower can be set to the treatment pressure Pth or set to the bedtime pressure Ps . The upper limit APAP pressure Pupper can be set to the specified maximum treatment pressure Pmax or set to the treatment pressure Pth. In this variation, the detection of the onset of sleep can still cause the PAP device (4000) to transition from the bedtime mode (4610) to the transition period (4620). In this variation, the bedtime mode (4610) still has a bedtime parameter that determines the timer limit for transitioning between bedtime mode (4610) and transition period (4620) without starting sleep as described above. This change also has an additional condition that causes the PAP device (4000) to transition from the bedtime mode (4610) to the transition period (4620), i.e., the treatment pressure Pt reaches the treatment pressure Pth before the start of sleep or the expiration of the timer. In this case, the transition period (4620) will not change the pressure, and the PAP device (4000) will immediately enter the treatment mode (4630), after which the pressure limits Plower and Pupper can be set to Pmin and Pmax , as described above. In this variation, APAP therapy is provided to the patient (1000) during bedtime mode (4610), although at a therapeutic pressure less than the therapeutic pressure Pth (hence, referred to as the "soft APAP" mode). If the lower limit APAP pressure Plower is set to the treatment pressure Pth , then since the reduction step (4560) does not allow the reduction of the pressure to be lower than the Plower , the treatment pressure Pt is avoided during the bedtime mode (4610). This allows the treatment pressure Pt to reach the treatment pressure Pth faster, and thus quickly enters the treatment mode (4630).

In still another variation of the initial phase of operation (4600), the transition period (4620) does not follow a predetermined pressure time pattern, but includes a soft APAP mode in which the treatment control module (4320) delivers APAP therapy to the patient ( 1000), for example, by the method embodiment (4500) (see FIG. 4E), which at bedtime mode (4610) termination of the treatment pressure to the treatment pressure Pt Pt initialization value. The lower limit APAP pressure Plower can be set to the treatment pressure Pth . The upper limit APAP pressure Pupper can be set to the specified maximum treatment pressure Pmax or set to the treatment pressure Pth . As with the initial mode of operation (4600) of Figure 4f, the transition period (4620) continues until the treatment pressure reaches the treatment pressure Pth, at which point the PAP device (4000) enters the treatment mode (4630). There is also an additional condition that causes the PAP device (4000) to transition from the transition period (4620) to the treatment mode (4630), that is, a timer limit determined from the transition time parameter expires. If the lower limit APAP pressure Plower is set to the treatment pressure Pth , then since the reduction step (4560) does not allow the reduction of the treatment pressure to be lower than the Plower , the reduction of the treatment pressure Pt is avoided during the transition period (4620). This allows the treatment pressure Pt to reach the treatment pressure Pth faster, and therefore, enters the treatment mode faster (4630).

Figures 4g, 4h, 4i, 4j(a), 4j(b), and 4k include an example of an initial stage of operation (4600) of the treatment engine module (4320) of Figure 4d as described above with reference to Figure 4f. figure.

In Figure 4g, the solid trace (4700) and the dashed trace (4730) represent the treatment pressure Pt that varies over time in different bedtime scenarios. The solid line in trace mode during bedtime (4700), the dashed line traces (4730) follows a continuous pressure mode at bedtime bedtime pressure Ps, which in this example has 4cmH ₂ O values. In the situation represented by the solid trace (4700), the start of sleep is detected at 10 minutes. At time (4710), the solid trace (4700) will follow the linear increase in the 2-minute transition time parameter. amounts to a minimum pressure Pmin treatment transition pattern (4720), in this example, it is 10cmH ₂ O, while the corresponding slope points 3cmH ₂ O /. In the situation represented by the dashed trace (4730), the sleep begins to be undetected, but conversely, the timer limit of the duration of the bedtime parameter equal to 28 minutes is reached, at time (4740), the solid trace (4700) Within a 2 minute transition time parameter, a transition pattern (4750) of linear increment to minimum treatment pressure Pmin is followed, which is equivalent to a slope of ₃ cm H ₂ O/min.

In Figure 4h, the trace (4760) represents the treatment pressure Pt over time. Traces (4760) during bedtime mode follows the mode for bedtime bedtime pressure Ps of the pressure, which in this example has 6cmH ₂ O values. The beginning of sleep is detected at 10 minutes. At time (4770), the trace (4760) is linearly incremented to the transition mode of minimum treatment pressure Pmin during the inspiratory portion of each respiratory cycle (4780), and The exhalation portion of each breathing cycle is a continuous pressure. In this example, each of the inspiratory portion and the expiratory portion of each breathing cycle lasts for one second. The slope of the linear increment is set such that the treatment pressure Pt reaches the minimum treatment pressure Pmin within a 7 second transition time parameter, which is equivalent to a slope of 1 cm H ₂ O per breath.

In Figure 4i, the trace (4790) represents the treatment pressure Pt over time. The trace (4790) during bedtime mode follows a series of linear increments of bedtime (4791) and a duration of 1 minute equal to one slope of 1 cm H ₂ O per minute, during which the treatment pressure is constant, insert 3 Minute pause period. The slope and duration of the linear increment, and the duration of the pause period are selected such that the treatment pressure Pt does not detect the onset of sleep, and the 21 minute bedtime parameter will reach the minimum treatment pressure Pmin , in this example It is 10 cmH ₂ O. The start of sleep is detected at 14 minutes. At time (4792), the trace (4790) follows a series of linear increments (4794) equal to one of the slopes of 1 cmH ₂ O per minute, and the duration of 1 minute, at During the period of constant treatment pressure, a 3 minute pause period was inserted. The slope and duration of the linear increments are the same as in the bedtime mode, which is 1 cm H ₂ O per minute and 1 minute. The duration of the pause period is selected to be 1 minute such that the treatment pressure Pt reaches the minimum treatment pressure Pmin at the transition time parameter of 3 minutes.

In Figure 4j(a), the trace (4800) represents the respiratory flow Qr over time, which shows an initial chaotic phase corresponding to the "wake up" sleep state (4810), and a later stable phase, at about 400 After a second, it corresponds to the "sleep" sleep state (4820). In Figure 4j(b), the trace (4830) represents the treatment pressure Pt over time. The trace (4830) during the bedtime mode typically corresponds to the "wake up" state (4810), which follows a linear increase from bed pressure Ps (in this example equal to 4 cm H ₂ O) to a minimum treatment pressure Pmin of 7 cm H ₂ O In bedtime mode (4840), the slope is set to 0.1cmH ₂ O per minute, so that Pt will start to detect no sleep, and the parameter will reach Pmin at 30 minutes before bedtime.

The sleep detection start during the bedtime mode is the transition between the "awake" state (4810) and the "sleep" state (4820). The Pt trace (4830) follows a linear increment to the minimum treatment pressure Pmin. The transition mode (4850) has a slope set to ₂ cm H ₂ O per minute, such that Pt will reach Pmin at a transition time parameter of 1 minute, which is substantially shorter than the 30 minute bedtime parameter. The dashed line (4860) represents the continuity of the bedtime mode (4840), rather than the actual follow-up because of the detection of the onset of sleep.

In Fig. 4k, the trace (4870) represents the treatment pressure Pt over time, wherein the bedtime mode (4610) is a soft APAP mode, the bed pressure Ps is set to 4 cm H ₂ O, and the treatment pressure Pth is set to 10 cm H ₂ O. The patient (1000) begins an event at time (4875), causing the treatment pressure Pt to begin to rise. A further event causes the treatment pressure Pt to occasionally increase until the treatment pressure Pt reaches the treatment pressure Pth at time (4880). Note that the treatment pressure Pt does not decrease between time (4875, 4880). The PAP device (4000) then enters a treatment mode (4630) where, at time (4885), an event results in a further increase in treatment pressure Pt .

The treatment parameter determines the deformation of the algorithm (4328)

In the variant of the treatment parameter decision algorithm (4328), the minimum treatment pressure Pmin that maintains the treatment pressure Pt (even in the absence of any indication of the SDB event) is not fixed, but may depend on the number of significant events occurring in the predetermined interval Ta. Adjustment. That is, if Na or more important events occur within an interval of Ta seconds, Pmin will increase by the increment Pmin . In one implementation of the variant of algorithm (4328), an important event is an SDB event, such as flow restriction, no breathing, low breathing, or nasal discharge, as determined by the determination of these quantities obtained as described above. In one example, Pmin is predetermined at 1 cm H ₂ O, Na is 3, and Ta is 2 minutes. In other embodiments, Pmin previously determined to be in the range of 0.2 to 4cmH ₂ O, or other values within 0.5 to 2cmH ₂ O. In other implementations, Ta is predetermined in the range of 30 seconds to 10 minutes, or other values within 1 to 4 minutes.

In still other implementations of this variant of the treatment parameter decision algorithm (4328), the delta Pmin is not predetermined, but depends on the current treatment pressure Pt . In this embodiment a, the delta by subtracting the current value of Pt is equal to Pmin to Pmin, so that treatment pressure Pmin to the current value of Pt.

This parameter determines in the treatment of some embodiments deformation algorithm (4328) in, Pmin maintained equal to or less than an upper limit Pmin_max, e.g. 10cmH ₂ O. In other implementations, the Pmin value does not have this upper limit. In an implementation, an important event is an SDB event.

In one embodiment, at bedtime Pmin is described above with respect to FIG. 4f cmH ₂ O mode (4610) or a transition period (4620) is not increased during, regardless of whether the significant events occurred.

Figure 41 includes a diagram illustrating the operation of different implementations of the therapy parameter decision algorithm (4328) implemented by the therapy engine (4320) of Figure 4d. In Fig. 41(a), the dotted trace (4950) and the solid trace (4940) represent the treatment pressure Pt (i.e., a current pressure) and the minimum treatment pressure Pmin over time of 300 to 1300 seconds, respectively. In Figure 41(b), the trace (4900) represents the respiratory flow Qr for 300 to 700 seconds at any time, which shows two SDB events, namely, first apnea (4910), second apnea (4920), It occurs between 400 and 450 seconds; and a third is no breathing (4930), which occurs about 530 seconds. The treatment pressure Pt dashed trace (4950) starts at 5 cm H ₂ O equal to Pmin and increases at position (4960) after the first apnea (4910); again at the position after the second apnea (4920) (4960) Increased and again increased at position (4980) after the third apnea (4930). The minimum treatment pressure Pmin increases from 4 cm H ₂ O to the current value of the treatment pressure Pt, which is 7 cm H ₂ O at position (4970) after the second apnea (4920), which would be detected within 2 minute intervals. Second no breathing (Na = 2, Ta = 120 seconds). In the absence of any subsequent SDB events, the treatment pressure Pt is gradually reduced to the (incremental) value of Pmin, which is 7 cm H ₂ O, reaching Pmin after about 1250 seconds. In an alternate implementation of the present technology, Na and Ta may differ from 2 and 120 seconds, respectively. For example, there are two no breaths in 1 minute, three no breaths in 2 minutes, five no breaths in 5 minutes, or an additional automatic adjustment to the minimum treatment pressure Pmin . In another alternative embodiment, when the treatment pressure Pt is lower than a predetermined threshold value, treatment can be avoided to reduce the pressure Pt. The predetermined threshold may be equal to a specified minimum treatment pressure.

More generally, a PAP device (4000) constituting a variant implementation of the above-described treatment parameter decision algorithm (4328) automatically adjusts the treatment over a range of pressure values, wherein the plurality of pressure value ranges are based on the detection one Or multiple breathing things It is automatically determined. In one form, the amount of pressure change (e.g., the amount of pressure increase) is a function of the pressure at which the event is detected.

In a further variant implementation of the treatment parameter determination algorithm (4328), if no breathing or low breathing is detected, such as in the step (4520) of the method (4500), the treatment parameter determination algorithm (4328) does not check the airway to Decide whether no breathing/low breathing is obstructive or central, as in step (4540) of method (4500). However, the processor (4230) checks the value of the current hood pressure Pm . If the hood pressure Pm is greater than or equal to a critical value Pthreshold , no breathing/low breathing is inferred to be a central non-breathing/low breathing; otherwise, no breathing/low breathing is inferred to be an obstructive non-breathing/low breathing. This inference is based on physiological observations that are more likely to be central rather than obstructive based on the high hood pressure Pm. Further differences are simpler than the above method (4500), but operate with substantially similar effectiveness. In an example, the threshold Pthreshold is 10 cm H ₂ O. In other implementations, the threshold Pthreshold is as low as 5 cm H ₂ O or as large as 20 cm H ₂ O, or as low as 8 cm H ₂ O or as large as 15 cm H ₂ O.

Control module (4330)

The treatment control module (4330) according to one aspect of the present technology receives the treatment parameters as input from the treatment engine module (4320) and controls the treatment device (4245) to deliver air flow based on the treatment parameters.

In one form of the present technology, the treatment parameter is a treatment pressure Pt, and the treatment control module (4330) controls the treatment device (4245) to deliver air flow with a hood pressure Pm at the patient interface (3000) equal to the treatment pressure Pt.

Detecting fault conditions (4340)

In one form of the present technology, a processor executes one or more methods for detecting a fault condition. Preferably, the fault condition detected by one or more methods includes at least one of the following:

‧Power failure (no power, or insufficient power)

‧ Converter fault detection

‧Cannot detect if component exists

‧ Operating parameters fall outside the recommended range (eg pressure, flow, temperature, PaO2)

‧ Cannot generate test alarms that can detect alarm signals.

After the fault condition is discovered, the corresponding algorithm fails with one or more of the following:

‧ Start audible, visual and / or power (such as oscillation) alarms

‧Transfer messages to external devices

‧ Record events

Humidifier (5000)

In one form of the present technology, a humidifier (5000) is provided that includes a water tank (5110) and a heating plate (5120).

Vocabulary

For the purposes of the present disclosure, in a particular form of the technology, applicable One or more of the following definitions. Other definitions may be applied in other forms of the technology.

General rule

Air: In a particular form of the technology, air may be used to mean atmospheric air, and in other forms of the technology, air may be used to mean some other combination of breathable gases, such as atmospheric air containing oxygen.

Positive airway pressure (PAP) treatment: continuous positive pressure in the atmosphere, the supply of air is supplied to the entrance of the airway.

Positive Airway Pressure (PAP) device: A device used to provide positive pressure airway therapy.

Continuous Positive Airway Pressure (CPAP) treatment: A positive pressure airway with a pressure that is approximately constant in the patient's breathing cycle. In some forms, the pressure at the airway inlet will vary by a few centimeters of water during a single breathing cycle, such as being higher during inhalation and lower during exhalation. In some forms, the pressure at the airway inlet will be slightly higher during exhalation and slightly lower during inhalation.

Automatic Positive Airway Pressure (APAP) treatment: The treatment pressure of automatic positive airway pressure therapy can be continuously adjusted between the minimum and maximum limits, depending on whether there is an indication of an SDB event.

Aspect of the PAP device

Air Circuit: A catheter or tube is constructed and configured to deliver an air supply between a PAP device and a patient interface. Special department, the airway can be The outlet of the pneumatic block is in fluid connection with the patient interface. The air passage can be referred to as an air delivery tube. In some cases, there may be individual limbs for inhalation and exhalation channels. In other cases, a single limb is used.

Blower: A gas element that delivers air flow at pressures above atmospheric pressure.

Controller: Adjusts the output of a device or part of a device based on the input. For example, one of the controllers has a variable under control, that is, a control variable that constitutes an input to the device; and a set point for the variable. The output of the device is a function of the control variable and the current value of the set point.

Transducer: A device used to convert one form of energy or signal into another. A transducer can be a sensor or detector for converting mechanical energy, such as kinetic energy, into an electrical signal. Examples of converters include pressure sensors, flow sensors, carbon dioxide (CO ₂ ) sensors, oxygen (O ₂ ) sensors, power sensors, motion sensors, noise sensors, and breathing Sgrapher and camera.

Aspect of the breathing cycle

Apnea: Preferably, no breathing occurs when the flow rate is, for example, 10 seconds duration below a predetermined threshold. An obstructive, non-breathing occurs when the airway does not allow airflow obstruction (regardless of patient effort). A central non-breathing occurs when the hairline is not breathing, due to reduced breathing force, or no breathing effort.

Breathing Rate: The patient's natural respiration rate, which is usually measured in terms of the number of breaths per minute.

Duty Cycle: The ratio of the inhalation time Ti to the total breathing time Ttot.

Breathing Effort: It is best to breathe. The force of breathing is the natural breathing of people trying to breathe.

Expiratory Portion of a Breathing Cycle: The period from the start of the expiratory flow to the beginning of the inspiratory flow.

Flow Limitation: Preferably, the flow limit is the state of the patient's respiratory event in which the patient increases the force without causing an increase in relative flow. The case where the flow restriction occurs during the inspiratory portion of the breathing cycle can be described as the inspiratory flow restriction. In the case where the flow restriction occurs in the expiratory portion of the breathing cycle, it can be described as an expiratory flow restriction.

Hypopnea: Preferably, low breathing refers to a decrease in flow but not a stop. In one form, the low breathing rate occurs when the duration of the flow decreases below a threshold. In one form of an adult, any of the following may be considered as low breathing: (i) at least 10 seconds for a 30% reduction in patient breathing plus 4% associated desaturation; or (ii) at least 10 seconds for a decrease in patient breathing (but Less than 50%), with at least 3% related to satiety or awakening.

The inspiratory portion of the breathing cycle: preferably, the period from the inspiratory flow to the beginning of the expiratory flow is the inspiratory portion of the breathing cycle.

Airway Patency: The extent to which the airway is open, or the extent to which the airway is open. An open airway is open. The airway can be quantified. For example, a value of 1 indicates openness and a value of 0 indicates airtightness.

Positive End-Expiratory Pressure (PEEP): There is a pressure in the lung where the end of exhalation exceeds the atmosphere.

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

Respiratory flow, air flow, patient airflow, respiratory airflow ( Qr ) (Respiratory Flow, Airflow, Patient Airflow, Respiratory Airflow): These synonyms are used to understand the PAP device estimates that are considered respiratory airflow, relative to "true respiratory flow" Or "True Breathing Flow", which is the actual respiratory flow experienced by the patient, usually expressed in units of liters per minute.

Tidal Volume: The amount of inhaled or exhaled air during normal breathing without additional force.

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

Exhalation Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

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

Typical Recent Ventilation: A value of ventilation that is a current value that tends to be dense over some predetermined time scale, that is, a measure of the central tendency of the most recent value of ventilation.

Upper Airway Obstruction (UAO): Includes local and total upper airway obstruction. This may be related to the state of the flow restriction, where the flow level is only slightly increased, or may even decrease as the pressure differential across the upper air passage increases (Starling resistance behavior).

Ventilation (Ventilation) (Vent): patient's respiratory system overall gas exchange measurements, including intake per unit time and / or expiratory flow. When expressed in units of "capacity per minute", this amount is often referred to as "dividing gas volume". The amount of gas exchange is sometimes expressed in terms of capacity and is known as "capacity per minute".

PAP device parameters

Flow Rate: The instantaneous volume (or mass) of air delivered per unit of time. Although the flow rate and the ventilation have the same volume or mass per unit time, the flow rate is measured over a relatively short period of time. The flow rate is a nominal positive value for the inspiratory portion of the patient's breathing cycle and is therefore negative for the expiratory portion of the patient's breathing cycle. In some cases, the flow rate is considered a scalar quantity, that is, an amount that is only the size. In other cases, traffic is considered as the amount of vector, that is, there is size and direction. The flow ratio (sometimes referred to as flow) will be represented by the symbol Q. The total flow rate Qt is the air flow leaving the PAP device. The ventilation flow rate Qv is the flow rate of air leaving the ventilation port to discharge the exhaled gas. The leakage flow Ql is the flow rate of accidental leakage from the patient interface system. The respiratory flow Qr is the air flow into the patient's respiratory system.

Leak: It is best to say that “leakage” is interpreted as the inflow of air into the daily environment. Leakage may be intended (e.g.) exhaled gases CO _2. Leaks may not be intended, for example, due to incomplete sealing between the nasal mask and the patient's face.

Pressure: The force per unit area. Pressure can be measured using different units, including cmH ₂ O, gf/cm2, and Hectopascal. 1 cm H ₂ O is equal to 1 g-f/cm ² and is approximately 0.98 hectopascal. In this specification, the pressure is in units of cmH ₂ O unless otherwise stated. The pressure of the patient interface is represented by the symbol Pm, and the treatment pressure (representing the target value to be achieved at the moment of the current time, the hood pressure Pm) is represented by the symbol Pt.

Anatomy of the respiratory system

Diaphragm: A muscle that extends over the bottom of the thorax. The diaphragm separates the chest from the abdominal cavity, including the heart, lungs, and ribs. As the diaphragm contracts, the volume of the chest increases and air is introduced into the lungs.

Larynx: The throat, or throat, accommodates the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

Lung: The respiratory organs of the human body. The conduction zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes respiratory bronchioles, alveolar ducts, and alveoli.

Nasal Cavity: The nasal cavity (or nasal cavity) is a large filling space above and behind the nose in the center of the face. The nasal cavity is divided into two parts by a vertical wing of the nasal septum. On the side of the nasal cavity are three horizontal growths called Nasal Conchae/Turbinates. The front of the nose is the nose, and the back is fused through the nasal hole in the nasopharynx.

Pharynx: The throat is located just below the nasal cavity (below), above the esophagus and throat. The pharynx is divided into three parts by convention: the nasopharynx (upper pharynx) (the nose of the pharynx), the oropharynx (the middle pharynx) (the mouth of the pharynx), and the hypopharynx (the hypopharynx).

Other statement

One of the exposures of this patent document includes content that is subject to copyright protection. The copyright holder has no objection to the facsimile reproduction of any of the patent documents or patent disclosures, as the disclosures appear in the Patent and Trademark Office patent files or records, but retain all copyrights.

Unless the context clearly dictates otherwise and provides a number of values, it should be understood that the intermediate value of one tenth of each of the lower limit units between the upper and lower limits of the range, and any other description or scope of the description herein The intermediate values are included in the technical scope. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also included in the art and are subject to any particular limitation within the scope of the description. system. Where a range of one or both of the limitations is included in the scope, the scope of the exclusion of any or both of these limitations is also encompassed within the present technology.

In addition, where one or more of the values described in this specification are implemented in part of the technology, it should be understood that this value can be an approximation unless otherwise stated, and this value can be used to allow or require Any valid number.

Unless otherwise defined, all technical and scientific terms used in the specification have the same meaning meaning Although any methods and articles similar or equivalent to those described in this specification can be used in the practice or testing of the present technology, the present description describes limited exemplary methods and articles.

When a particular item is considered to be best used to form a component, a distinct substitute of similar characteristics can be used as an alternative. In addition, any and all components discussed herein should be understood to be manufacturable and can be manufactured together or separately, unless otherwise specifically stated herein.

It must be noted that the use of the terms "a", "an" and "the"

All publications discussed in this specification are incorporated herein by reference in their entirety in their entirety in the extent of the disclosure. The publications discussed in this specification are provided for the purpose of the disclosure of the disclosure of the application of the present application, and are not to be construed as an admission In addition, the date of publication provided may differ from the actual publication date, which may require individual confirmation.

Moreover, in interpreting the invention, all terms should be interpreted in the most reasonable manner consistent with the specification. In particular, the words "including" and "comprising" are used to mean a non-exclusive description of the elements, components, or steps, and the elements, components or steps that may be referred to, or combinations or combinations of other elements not specifically mentioned, Component or step.

The headings used in the embodiments are included for the convenience of the reader and are not intended to limit the scope of the invention or the scope of the claims. The subject matter should not be used to form a scope that limits the scope of the patent application.

Although the present technology has been described herein with reference to the specific embodiments, it is understood that these specific embodiments are merely illustrative of the principles and applications of the present technology. In some instances, the terms and symbols may imply that no particular detail is required to implement the technique. For example, although the preambles "first" and "second" may be used, unless otherwise specified, no order is specified, but can be used to distinguish different components. Moreover, although the processing steps in the methods can be described or illustrated in the sequence, this order is not necessarily required. Those skilled in the art will appreciate that this sequence can be modified and/or its aspects can be performed simultaneously or even simultaneously.

Therefore, it is to be understood that the invention may be embodied in a particular embodiment, and other configurations may be devised without departing from the spirit and scope of the invention.

4600‧‧‧ operation

4610‧‧‧ bedtime mode

4620‧‧‧ transition period

4630‧‧‧ treatment mode

Claims (31)

A device for treating a respiratory disorder, comprising: a pressure device; and a controller comprising at least one processor configured to control the pressure device to perform the following: when starting treatment, according to a pressure and The time-compared bedtime mode supplies the pressurized air flow to the patient's airway under a treatment pressure; when detecting the patient's fall of sleep, the treatment pressure is increased according to a transition mode in which the pressure is compared with time. To a predetermined therapeutic pressure; and under a therapeutic pressure, the pressurized air flow is supplied to the patient's airway. The device of claim 1, wherein the bedtime mode is determined by the processor according to a bedtime parameter, and wherein the processor determines the transition mode according to a transition time mode, and wherein the transition is The time parameter is substantially shorter than the bedtime parameter. The device of claim 2, wherein the bedtime mode is a constant value that is equal to the bedtime pressure for a duration equal to the bedtime parameter. The device of claim 2, wherein the bedtime mode is a linear increment, the selected slope of which causes the pressure to detect the treatment pressure at the bedtime parameter at the beginning of no sleep. The device of claim 2, wherein the bedtime mode is a series of linear increments separated by a pause period during a pressure invariance, wherein the slope and duration of the linear increment, and a pause period duration Selected so that when no sleep falls to detect, the pressure will reach the treatment pressure at the bedtime parameter. The device of any one of claims 2 to 5, wherein The transition mode is a linear increment with a selected slope such that the pressure reaches the treatment pressure at the transition time parameter. The apparatus of any one of claims 2 to 5, wherein the transition mode is a series of linear increments separated by a pause period during a pressure invariance, wherein the slope and duration of the linear increment, and The pause period duration is selected such that the pressure reaches the treatment pressure at the transition time parameter. The device of claim 1, wherein the bedtime mode is determined by the processor according to a pre-sleeping slope, the transition mode being determined by the processor according to a transition slope, and wherein the transition slope is substantially Higher than the bedtime slope. The device of claim 8, wherein the bedtime mode is a constant value equal to a bedtime pressure. The device of claim 8, wherein the bedtime mode is a linear increment of one of the slopes, which is equal to the pre-sleep slope. The device of claim 8, wherein the bedtime mode is a series of linear increments separated by a pause period during a pressure invariance, wherein the slope of the linear increment is equal to the bedtime slope. The device of claim 8, wherein the bedtime mode is a series of linear increments that match the inspiratory portion of each breathing cycle, and the string linear increments are separated by a pause period, which remains constant at pressure The exhalation portion of each respiratory cycle is met during the period, wherein the slope of the linear increment is equal to the pre-sleep slope. The apparatus of any one of claims 8 to 12, wherein the transition mode is a linear increment having a slope equal to the transition slope. The device of any one of claims 8 to 12, wherein The transition mode is a series of linear increments separated by a pause period during a pressure invariant period, wherein the slope of the linear increment is equal to the transition slope. The apparatus of any one of claims 8 to 12, wherein the transition mode is a series of linear increments that match the inspiratory portion of each breathing cycle, and the string linear increments are separated by a pause period, The expiratory portion of each breathing cycle is met during the period in which the pressure remains constant, wherein the slope of the linear increment is equal to the transition slope. The device of any one of claims 1 to 15, wherein the processor detects the onset of sleep in one or more of the following situations: multiple occurrences of sleep disordered breathing events within a first predetermined interval; A second predetermined interval with little or no breathing disorder. The device of any one of claims 1 to 16, wherein the controller further comprises controlling the pressure device to increase the treatment pressure to the predetermined time according to the transition mode when a predetermined timer limit expires Treatment pressure. The device of any one of claims 1 to 17, wherein the treatment pressure is the predetermined treatment pressure. The device of any one of claims 1 to 17, wherein the treatment pressure is altered according to the occurrence of a sleep disordered breathing event. A method of treating a respiratory disorder, the method comprising: when starting treatment, supplying a flow of pressurized air to a patient's airway under a treatment pressure according to a bedtime mode compared to a pressure versus time; when detecting a patient At the beginning of sleep, the treatment pressure is increased to a predetermined treatment pressure according to a transition mode of pressure versus time; and under the treatment pressure, the flow of pressurized air is supplied to the airway of the patient. A device for treating a respiratory disorder, comprising: a pressure device; a controller comprising at least one processor configured to control the pressure device: when the treatment is initiated, the pressurized air flow is supplied to the airway of the patient under a treatment pressure from a pre-sleep pressure, and Changing according to the occurrence of a sleep disordered breathing event; when detecting the start of sleep of the patient, increasing the treatment pressure to a predetermined treatment pressure according to a transition mode of pressure versus time; and under a treatment pressure, The pressurized air flow is supplied to the airway of the patient. The device of claim 21, wherein the controller is further configured to control the pressure device to increase the treatment pressure to the predetermined treatment pressure according to the transition mode when a predetermined timer limit expires. The device of any one of claims 21 to 22, wherein the controller further comprises controlling the pressure device to increase the treatment pressure to the transition mode according to the transition mode when the treatment pressure reaches the predetermined treatment pressure The predetermined treatment pressure. The device of any one of claims 21 to 23, wherein the treatment pressure is changed according to the occurrence of the sleep disordered breathing events, avoiding reducing the treatment pressure. The device of any one of claims 21 to 24, wherein the treatment pressure is changed between a predetermined bedtime pressure and the predetermined treatment pressure based on the occurrence of the sleep disordered breathing events. A method for treating a respiratory disorder, the method comprising: when starting treatment, supplying a flow of pressurized air to a patient's airway under a therapeutic pressure from a pre-sleep pressure, and according to the sleep disordered breathing The occurrence of the event changes; when detecting the patient’s fall of sleep, the transition based on a pressure versus time The mode increases the therapeutic pressure to a predetermined therapeutic pressure; and, under a therapeutic pressure, supplies the pressurized air flow to the airway of the patient. A device for treating a respiratory disorder, comprising: a pressure device; and a controller comprising at least one processor configured to control the pressure device to perform the following: when starting treatment, according to a pressure and Time-compared bedtime mode, the pressurized air flow is supplied to the patient's airway under a treatment pressure; when detecting the patient's falling into sleep, the treatment pressure is adjusted according to the occurrence of the sleep-disordered breathing event; When the treatment pressure reaches a predetermined treatment pressure, the flow of pressurized air is supplied to the airway of the patient. The device of claim 27, wherein the controller is further configured to control the pressure device to supply the flow of pressurized air to the airway of the patient under the treatment pressure when a predetermined timer limit expires. The device of any of claims 27 and 28, wherein the controller is configured to control the pressure device to adjust the treatment pressure based on the occurrence of a sleep disordered breathing event to avoid reducing the treatment pressure. The device of any one of claims 27 to 29, wherein the controller is configured to control the pressure device to adjust the treatment pressure to be lower than the predetermined treatment pressure in response to the occurrence of a sleep disordered breathing event. A method of treating a respiratory disorder, the method comprising: when starting treatment, supplying a flow of pressurized air to a patient's airway under a treatment pressure according to a bedtime mode compared to a pressure versus time; when detecting a patient Adjusting the treatment pressure according to the occurrence of a sleep disordered breathing event at the beginning of sleep; and When the treatment pressure reaches a predetermined treatment pressure, the pressurized air flow is supplied to the airway of the patient under a treatment pressure.