TWI658845B - Method and apparatus for treatment of respiratory disorders - Google Patents

Abstract

The invention discloses a device for treating respiratory disorders. The device includes: a pressure device; and a controller including at least one processor, the controller is configured to control the pressure device to perform the following: when starting treatment, according to a bedtime mode in which pressure is compared with time, The pressurized air flow is supplied to the patient's airway under a treatment pressure; when the patient's onset of falling asleep is detected, the treatment pressure is increased to a predetermined treatment pressure according to a pressure-to-time transition mode; The flow of pressurized air is supplied to the patient's airway under a treatment pressure.

Description

Method and device for treating respiratory disorder

This technology relates to the detection, diagnosis, treatment, prevention, and improvement of one or more of the respiratory-related disorders. More specifically, the present technology relates to medical devices or devices, and uses thereof.

Human respiratory system and disorder

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

The airway includes a series of branch tubes that become narrower, shorter, and more as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter venous blood from the air and expel carbon dioxide. The trachea is divided into right and left main bronchi, and finally divided into terminal bronchi. The bronchus forms a conducting airway and does not participate in gas exchange. Further branching of the airways leads to the breathing bronchioles and eventually to the alveoli. The alveolar region of the lungs is where the gas exchange takes place and is called the breathing zone. See the 9th edition released in 2011 by John B. Wester, Lippincott Williams, and Wilkins, entitled "Respiratory Physiology".

The presence of breathing disorders

Obstructive Sleep Apnoea (OSA) is a form of Sleep Disordered Breathing (SDB), which is characterized by upper airway occlusion during sleep. This is a combination of abnormally small upper airways and normal loss of muscle tension during sleep, soft palate and posterior pharyngeal wall during sleep. This symptom causes affected patients to typically stop breathing each night for a duration of 30 to 120 seconds, sometimes 200 to 300 seconds. This often causes excessive daytime sleepiness, and may cause cardiovascular disease and brain damage. Complications are general disorder, especially in middle-aged overweight men, although affected people may not notice the problem. See US Patent No. 4,944,310 (Sullivan).

Cheyne-Stokes Respiration (CSR) is a disorder of the patient's respiratory organ regulation system. Among them, there is a rhythmic alternating period of ups and downs, which causes repeated hypoxia and reoxygenation of arterial blood. Chen-Shi breathing may be harmful due to repetitive oxygen deficiency. In some patients, Chen-Shi respiration (CSR) is associated with repeated wakefulness from sleep, which can cause severe sleep disintegration, increase sympathetic activity, and increase postload. 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 on waking without other known factors of hypoventilation. Symptoms include difficulty breathing, headaches in the morning, and excessive sleep during the day.

Chronic Obstructive Pulmonary Disease (COPD) includes any of a number of low-airway diseases with common specific characteristics. These include increased resistance to air flow, prolonged breathing phase, and loss of normal lung flexibility. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (major risk factors), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exercise, chronic cough, and sputum production.

Neuromuscular Disease (NMD) is a broad term that includes many diseases and disorders that damage muscle function directly through essential muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle injury that leads to reduced mobility (requires a wheelchair), difficulty swallowing, respiratory muscle failure, and finally, respiratory failure leading to death. Neuromuscular diseases can be divided into rapid progressive and chronic progressive: (i) rapid progressive disorder: characterized by worsening muscle damage over several months and causing death within a few years (for example, amyotrophic lateral sclerosis in adolescents (ALS) and Juchen's muscular dystrophy (DMD)); (ii) variable or slow progressive disorder: characterized by muscle damage that has deteriorated for more than a few years and only slightly reduced the likelihood of life expectancy (for example, Band type, facial shoulder-arm type, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, dyspnea and rest during exercise, tiredness, sleepiness, morning headache, difficulty concentrating, and mood changes.

Thoracic wall disorders are thoracic deformations that cause inefficient coupling between the breathing muscles and the thorax. Thoracic wall disorders are often characterized as a restrictive disorder and share the potential for chronic hypercapnia respiratory failure. Scoliosis and / or posterior scoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: exercise dyspnea, peripheral edema, sitting breaths, periodic chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.

Otherwise, healthy individuals can use systems and devices to avoid breathing problems.

treatment

Nasal Continuous Positive Airway Pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The assumption is that continuous positive airway pressure acts as a blow splint, and upper airway obstruction can be avoided by pushing the soft palate and tongue forward and away from the posterior pharynx wall.

Non-Invasive Ventilation (NIV) provides ventilator support to the patient through the upper airway to assist the patient in taking a full breath and / or performing some or all breathing tasks 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 chest wall disorders.

system

One known device for providing CPAP therapy (Positive Airway Pressure (PAP) device) is the S9 sleep therapy system, which is manufactured by ResMed. Respirators (such as the ResMed Stellar ^TM series of adult and pediatric respirators) can provide non-invasive and independent ventilation support to different patients for treating different conditions, such as but not limited to CSR, NMD, OHS, and COPD.

A system may 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 breathing apparatus and its user, for example by providing a flow of air. Air flow can be provided to the nose and / or mouth through a nasal mask, to the mouth through a tube, or to the user's trachea through a gas-cut tube. Depending on the treatment to be applied, the patient interface may, for example, form a seal with the patient's facial area to facilitate gas transfer at a pressure that is sufficiently different from ambient pressure to exert a therapeutic effect, such as a positive pressure of about 10 cm H ₂ O. 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. A PAP device or respirator typically includes a pressure device, such as a motor-driven inflator or a compressed gas tank, and constitutes an airway that supplies air to a patient. In some cases, a positive pressure air flow 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 described above.

The technology aims at providing medical devices for diagnosing, improving, treating or preventing respiratory disorders, and has one or more of improved comfort, cost, efficiency, ease of use, and manufacturability.

One of the first aspects of the technology relates to the diagnosis, improvement, treatment or prevention of respiratory diseases. Device for suction disorders.

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

One aspect of the technology includes a method and device for treating a respiratory disorder, which uses an initial stage of an operation to put a patient to sleep before starting treatment and before transmitting treatment pressure. During the initial phase of the procedure, the treatment pressure follows a bedtime pattern and is designed to keep the patient asleep. The treatment pressure then follows a transition pattern so that the treatment pressure becomes a minimum treatment pressure during which treatment can begin. Preferably, the transition from bedtime mode to transition mode can be caused by the detection of the beginning of falling asleep.

According to an aspect of the present technology, a device for treating a respiratory disorder is provided, including: 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 in which pressure is compared with time when the treatment is started; At the beginning of falling asleep, the treatment pressure is increased to a predetermined treatment pressure according to a transition mode of pressure to time comparison; and at a treatment pressure, the pressurized air is supplied to the airway of the patient.

According to another aspect of the present technology, a method for treating a breathing disorder is provided. The method includes: when starting the treatment, supplying the pressurized air to the airway of the patient under a treatment pressure according to a bedtime mode in which pressure is compared with time; The transition mode compared to time increases the treatment pressure to a predetermined treatment pressure; and at a treatment pressure, the pressurized air is supplied to a patient's airway.

According to another aspect of the present technology, a device for treating a breathing disorder is provided. The device includes: a pressure device; and a controller including at least one processor. The controller is configured to control a pressure device to supply the pressurized air to the patient's airway under a treatment pressure when the treatment is started, which starts at a pre-sleep pressure and is based on the occurrence of a sleep disordered breathing event. While changing; when detecting the beginning of falling asleep of the patient, increasing the treatment pressure to a predetermined treatment pressure according to a transition mode of pressure to time comparison; and supplying the pressurized air to the airway of the patient at a treatment pressure.

According to another aspect of the present technology, a method for treating a breathing disorder is provided. The method includes: when starting treatment, supplying the pressurized air to a patient's airway under a treatment pressure, which starts at a pre-sleep pressure and changes according to the occurrence of a sleep disordered breathing event; when detecting a patient At the beginning of falling asleep, the treatment pressure is increased to a predetermined treatment pressure according to a transition mode of pressure to time comparison; and at a treatment pressure, the pressurized air is supplied to the airway of the patient.

According to another aspect of the present technology, a device for treating a breathing 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 in which pressure is compared with time when the treatment is started; when the patient is detected At the beginning of falling asleep, the treatment pressure is adjusted according to the occurrence of a sleep apnea 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 for treating a breathing disorder is provided. The method includes: when starting treatment, supplying the pressurized air to the airway of the patient under a treatment pressure according to a bedtime mode in which pressure is compared with time; when detecting the start of falling asleep of the patient, breathing according to sleep The occurrence of an obstacle event adjusts the treatment pressure; and when the treatment pressure reaches a predetermined treatment pressure, the pressurized air is supplied to a patient's airway under a treatment pressure.

Of course, these aspects may form subsidiary aspects of the technology. At the same time, these different aspects and / or various aspects of the aspects can be combined in various ways, and also constitute additional aspects or subsidiary aspects of the technology.

Other features of the technology can be made clearer by considering the information contained in the following "Embodiments", "Abstracts", "Simplified Illustrations", and "Scope of Patent Application".

1000‧‧‧patients

3000‧‧‧ full face mask

3100‧‧‧Sealed to form structure

3200‧‧‧air cavity

3300‧‧‧ Structure

3400‧‧‧Air vent

3600‧‧‧connect port

4000‧‧‧ Positive Airway Pressure (PAP) Device

4010‧‧‧Shell

4012‧‧‧ Upper part

4014‧‧‧ Lower part

4015‧‧‧face plate

4016‧‧‧Base

4018‧‧‧Ring handle

4020‧‧‧Pneumatic block

4100‧‧‧Pneumatic components

4110‧‧‧Air Filter

4112‧‧‧Air intake filter

4114‧‧‧Air outlet filter

4120‧‧‧ Silencer

4122‧‧‧Air inlet muffler

4124‧‧‧Outlet muffler

4140‧‧‧Pressure device

4142‧‧‧Blower

4144‧‧‧Brushless DC Motor

4160‧‧‧Backflow prevention valve

4170‧‧‧Airway

4180‧‧‧ supplemental 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‧‧‧Therapeutic 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 Device

4290‧‧‧Output device

4292‧‧‧Display Driver

4294‧‧‧Display

4300‧‧‧ Algorithm

4310‧‧‧Pretreatment module

4312‧‧‧Pressure compensation

4314‧‧‧Air vent flow algorithm

4316‧‧‧Leak Flow Algorithm

4318‧‧‧Respiratory Flow Algorithm

4320‧‧‧Therapy Engine Module

4321‧‧‧phase determination algorithm

4322‧‧‧ Waveform Decision Algorithm

4323‧‧‧Ventilation decision algorithm

4324‧‧‧Inspiratory flow limit decision

4325‧‧‧No Breathing / Low Breathing Decision Algorithm

4326 ‧ ‧ ‧ nose nose algorithm

4327‧‧‧Determining algorithm for unobstructed airway

4328‧‧‧Therapeutic parameter determination algorithm

4330‧‧‧Control Module

4340‧‧‧Failure Condition Module

4500‧‧‧Method

4520‧‧‧ steps

4530‧‧‧ steps

4540‧‧‧step

4550‧‧‧step

4560‧‧‧step

4600‧‧‧operation

4610‧‧‧ Bedtime Mode

4620 ‧‧‧ transition period

4630‧‧‧Treatment Mode

4700‧‧‧Solid stitch

4710‧‧‧time

4720‧‧‧ Transition Mode

4730‧‧‧ dotted trace

4740‧‧‧time

4750‧‧‧ transition mode

4760‧‧‧trace

4770‧‧‧time

4780 ‧‧‧ transition mode

4790‧‧‧trace

4791‧‧‧bedtime mode

4792‧‧‧time

4794‧‧‧ transition mode

4800‧‧‧trace

4810‧‧‧State

4820‧‧‧State

4830‧‧‧trace

4840‧‧‧ Bedtime Mode

4850‧‧‧ Transition Mode

4860‧‧‧ dotted line

4870‧‧‧trace

4875‧‧‧time

4880‧‧‧time

4885‧‧‧ time

4900‧‧‧trace

4910‧‧‧No breath

4920‧‧‧No breath

4930‧‧‧No breath

4940‧‧‧Solid stitch

4950‧‧‧ dotted trace

4960‧‧‧Location

4970‧‧‧Location

4980‧‧‧Location

5000‧‧‧ humidifier

5110‧‧‧Sink

5120‧‧‧Heating plate

5250‧‧‧Humidifier Controller

The technology is described by way of non-limiting example in conjunction with the accompanying drawings, where the same reference numbers represent similar elements, including:

Treatment system

Figure 1a shows a system according to the present technology. The patient (1000) wears a patient interface (3000) and receives a positive pressure ventilation supply from a PAP device (4000). The air from the PAP device is moistened by the humidifier (5000) and passed to the patient (1000) along the air path (4170).

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

Figure 1c shows a PAP device (4000) used on 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 oral cavity, throat, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm.

Figure 2b shows a diagram of the human upper airway route, including nasal cavity, nasal bone, lateral nasal cartilage, large nasal cartilage, nostril, upper lip, lower lip, throat, hard jaw, soft jaw, oropharyngeal tongue, throat cover, vocal cord, esophagus and trachea .

Patient interface

Figure 3a shows a patient interface (3000) according to one form of the technology.

PAP device

Figure 4a shows a PAP device (4000) according to one form of the technology.

Figure 4b shows a schematic diagram of the gas path of a PAP device (4000) according to one form of the technology, in which the upstream and downstream directions are indicated.

Figure 4c shows a schematic diagram of the electrical components of a PAP device (4000) according to one aspect of the technology.

Figure 4d shows a schematic diagram of an algorithm (4300) implemented in a PAP device (4000) according to one aspect of the technology. In this diagram, solid arrows indicate the actual flow of information, such as through electronic signals.

FIG. 4e is an illustration illustrating the treatment via FIG. 4d according to one aspect of the present technology. Flow chart of method (4500) implemented by engine module (4320).

FIG. 4f is a state diagram illustrating the initial stage of the operation of the treatment engine module (4320) of FIG. 4d according to an example of one aspect of the 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) and 41 (b) include diagrams illustrating different implementation operations of the treatment parameter determination algorithm (4328) implemented by the treatment engine module (4320) of FIG. 4d.

Humidifier

Figure 5a shows a humidifier (5000) according to one aspect of the technology.

Breathing waveform

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

Before describing the technology in more detail, it should be understood that the technology is not limited to the specific examples described in this specification, and the examples may vary. At the same time, it should be understood that the present invention enables The terminology used is intended to describe only the specific examples discussed in this specification and not to limit them.

treatment

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

Treatment system

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

Patient Interface (3000)

A non-invasive patient interface (3000) according to one aspect of the technology includes the following functional aspects: a seal-forming structure (3100); an air cavity (3200); a positioning and stabilization 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 may provide one or more functional aspects. In use, the seal-forming structure (3100) is disposed at the entrance of the airway surrounding the patient, and facilitates the supply of positive-pressure air to the airway.

PAP device (4000)

It should be understood that the PAP device (4000) is described below as only one form of a breathing apparatus. In addition, those skilled in the art should understand that aspects of the technology can be applied to other forms of breathing devices, such as respirators.

A PAP device (4000) according to one aspect of the technology includes mechanical and pneumatic components (4100), electrical components (4200), and is programmed to execute one or more algorithms (4300). The PAP device (4000) preferably has a casing (4010). The casing is preferably formed using two parts, an upper part (4012) of the casing (4010), and a lower part (4014) of the casing (4010). In an alternative form, the housing (4010) may 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 a base (4016). The PAP device (4000) may include a ring handle (4018).

The pneumatic path of the PAP device (4000) preferably includes: an intake filter (4112); an intake muffler (4122); a pressure controllable device (4140), which can supply positive pressure air (preferably a drum Air machine (4142)); and an exhaust muffler (4124). One or more sensors or transducers (4270) are included in the pneumatic path.

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

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

PAP Device Mechanical and Pneumatic Components (4100)

Air filter (4110)

A PAP device according to one form of the technology may include an air filter (4110), or a plurality of air filters (4110).

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

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

Silencer (4120)

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

In one form of the technology, an exhaust muffler (4124) is disposed on the pneumatic path between the pressure device (4140) and a patient interface (3000).

Pressure device (4140)

In a preferred form of the technology, a pressure device (4140) for generating a positive pressure air flow is a controllable blower (4142). For example, the blower may include a brushless direct current (DC) motor (4144) having one or more impellers housed in a volute. The blower is preferably capable of delivering an air supply, for example, at a positive pressure ranging from about 4 cmH 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 a treatment device controller (4240).

Converter (4270)

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

In one form of the technology, one or more converters (4270) are provided 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 certain point in the pneumatic path.

In one form of the technology, one or more converters (4270) are disposed near the patient interface (3000).

Backflow prevention valve (4160)

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

Airway (4170)

The air path (4170) according to one aspect of the technology is configured and configured to allow air to flow between the pneumatic block (4020) and the patient interface (3000).

Supplemental oxygen (4180) delivery

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

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

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

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

Electrical components for PAP devices (4200)

Power Supply (4210)

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

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

Input devices (4220)

In one form of the technology, a PAP device (4000) includes one or more input devices (4220) in the form of buttons, switches, or rotary disks, allowing personnel to interact with the device. The buttons, switches or dials can be physical devices or software devices accessed via a touch screen. In one form, the button, switch or rotary dial can be physically connected to the housing (4010); or in another form, wireless communication can be performed with a receiver electrically connected to the central controller (4230).

In one form, the input device (4220) may 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 technology, the central controller (4230) is a processor suitable for controlling a PAP device (4000), such as an x86 INTEL processor.

A processor (4230) suitable for controlling another form of PAP device (4000) according to the 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 further alternative form of PAP device (4000) according to the present technology includes a component selected from a series of ARM9 based 32-bit RISC CPUs. For example, STR9 series microcontrollers from ST MICROELECTRONICS can be used.

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

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

The processor (4230) may be configured to provide output signals to one or more of an output device (4290), a treatment device controller (4240), a data communication interface (4280) and a humidifier controller (5250).

In some forms of the technology, the processor (4230), or multiple such processors, constitute one or more methods described in this specification, such as one or more algorithms (4300), which are stored in non-transitory A computer program representation of a computer-readable storage medium, such as memory (4260). In some cases, as previously discussed, this processor may be integrated with a PAP device (4000). However, in some forms of the technology, the processor may be implemented separately from the pneumatic components of the PAP device (4000), such as to perform any of the methods discussed in this specification, without the need to directly control the delivery of respiratory therapy. For example, to decide on a respirator or other breathing-related matters For the purpose of controlling the set value of the software, this processor can perform any of the methods discussed in this specification by analyzing data stored from any of the sensors 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 preprocessing module (4310), a treatment 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), which is connected to the processor (4230).

Therapeutic Device Controller (4240)

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

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

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

Therapy Devices (4245)

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

Preferably, the treatment 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 form of the protection circuit (4250) according to the present technology is 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)

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

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

In addition (or), the PAP device (4000) includes a removable memory (4260), such as a memory card manufactured according to the Secure Digital (SD) standard.

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

Converter (4270)

The converter may be internal to the PAP device (4000) or external to the PAP device (4000). The external converter may be provided, for example, in the portion or form of the airway (4170) in that portion, such as in the patient interface (3000). The external converter can be in the form of a non-contact sensor, such as a Doppler radar motion sensor, which can transmit or transfer data to the PAP device (4000).

Flow Converter (4274)

One of the flow converters (4274) according to the present technology may be based on a differential pressure converter, such as the SDP600 series differential pressure converter from SENSIRION. The differential pressure converters are in fluid communication with each of the pneumatic circuits and the pressure converters, which are connected to individual first and second points in a flow limiting element.

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

Pressure converter (4272)

A pressure converter (4272) according to one of the techniques is provided for fluid communication with a pneumatic path. An example of a suitable pressure converter (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 converter (4272) is received by the processor (4230). In one form, the signal is filtered before the processor (4230) receives the signal from the pressure converter (4272).

Motor speed (4276)

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

Data Communication Interface (4280)

In a preferred form of the technology, a data communication interface (4280) is provided and connected to the processor (4230). The data communication interface (4280) can preferably be connected to a remote external communication network (4282). Data communication interface (4280) is best connected to local external communication Communication 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 the 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 separated from the processor (4230).

In one form, the remote external communication network (4282) is the Internet. The data communication interface (4280) can use wired communication (for example, via Ethernet, or optical fiber) or wireless protocols to connect to the Internet.

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

In one form, the remote external device (4286) is one or more computers, such as a cluster of computers connected via a network. In one form, the remote external device (4286) may be a virtual computer, rather than a physical computer. In either case, this remote external device (4286) can be accessed by a suitably legal person, such as a clinician.

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

Including selective display and alarm output devices (4290)

The output device (4290) according to this technology can use vision, audio and tactile The form of one or more of the units. A visual display may be a Liquid Crystal Display (LCD) or a Light Emitting Diode (LED) display.

Display Driver (4292)

A display driver (4292) receives characters, symbols, or images as input for display on the display (4294), and converts them into commands to cause the display (4294) to display such characters, symbols, or images .

Displays (4294)

A display (4294) constitutes visual display characters, symbols or images in response to commands received from the display driver (4292). For example, the display (4294) may be an eight-segment display. In this case, the display driver (4292) converts each character or symbol (such as the number "0") into eight logical signals, indicating whether to stimulate eight individual segments. To display special characters or symbols.

PAP Device Algorithm (4300)

Pre-processing module (4310)

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

In one form of the technology, the output values include interface or mask pressure Pm , breathing flow rate Qr , and leakage flow rate Ql .

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

Pressure compensation (4312)

In one form of the technology, a pressure compensation algorithm (4312) receives a signal as an input to indicate the pressure of the pneumatic block (4020) near the outlet of the pneumatic path. A pressure compensation algorithm (4312) evaluates the pressure drop in the air path (4170) and provides an estimated pressure Pm as an output at the patient interface (3000).

Exhaust port flow (4314)

In one form of the present technology, a ventilation port flow calculation algorithm (4314) receives an estimated pressure Pm as an input at the patient interface (3000), and estimates at the patient interface (3000) that it comes from the ventilation port (3400). ) Vent air flow Qv .

Leakage (4316)

In one form of the technology, a leakage flow algorithm (4316) receives a total flow Qt and a vent flow Qv as inputs, and calculates the average value of Qt-Qv to include Several breathing cycles (for example, about 10 seconds) to provide a leak flow Ql as an output.

In a form, the leakage flow algorithm (4316) receives a total flow Qt , a vent flow Qv , and an estimated pressure Pm as inputs from the patient interface (3000), and calculates a leakage conductance, and determines A leakage flow rate Ql as a function of the leakage conductance and a mask pressure Pm are provided to provide a leakage flow rate Ql as an output. Preferably, the leakage conductance is calculated by the quotient of the low-pass filtered non-ventilation port flow Qt-Qv and the low-pass filtered square root of the shroud pressure Pm , where the low-pass filtering time constant has a sufficiently long value to include the number Breathing cycle, for example about 10 seconds.

Respiratory Flow (4318)

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

Healing Engine Module (4320)

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

In various forms, the treatment engine module (4320) includes one or more of the following algorithms: phase decision (4321), waveform decision (4322), ventilation decision (4323), inspiratory flow limit decision (4324) No breath / low breath decision (4325), Nasal diaphragmatic decision (4326), airway decision (4327), and treatment parameter decision (4328).

Phase determination (4321)

In one form of the technology, a phase determination algorithm (4321) receives an indication of a breathing flow Qr signal as an input, and provides a breathing cycle phase of a patient (1000) as an output.

In one form, the phase output is a discontinuous variable with an inspiratory or expiratory value. In the implementation of this form, when the respiratory flow rate Qr has a positive value exceeding a positive critical value, it is determined that the phase output has a discontinuous value of inhalation, and when the respiratory flow rate Qr has a negative value lower than a negative critical value, It is determined that this phase has a discontinuity in exhalation.

In one form, the phase output is a discontinuous variable having a value of any of inhalation, inhalation, and expiration.

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 technology, a control module (4330) controls a treatment device (4245) to provide a nearly stable positive airway pressure during the patient's breathing cycle.

In one form of the technology, a control module (4330) controls a treatment device (4245) to provide a positive airway pressure based on a predetermined waveform that compares pressure to phase. In one form, all values of the waveform for phase are maintained at approximately stable levels. In one form, the waveform is a square wave, which has higher values for some phase values and lower levels for other phase values.

In one form of the present technology, a waveform determination algorithm (4322) receives a value as an input, which is used to indicate the current patient ventilation Vent, and provides a pressure and phase comparison waveform as an output.

Ventilation Decision (4323)

In one form of the present technology, a ventilation decision algorithm (4323) receives a breathing flow rate Qr as an input, and determines a measurement value that instructs the patient to ventilate Vent.

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

Inspiratory flow limit decision (4324)

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

In one form, the algorithm (4324) receives a breathing 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 limit.

In one form of the technique, the inspiratory portion of each breath is identified by a zero-crossing detector. The number of average separation points (eg, 65) representing time points can be inserted by the inserter along the inspiratory flow-time curve for each breath. The curve described by the points is then scaled via a scaler to have unit length (duration / period) and unit area to remove the effect of changing respiration rate and depth. A comparator then compares the calibrated breath with a pre-stored template representing a normal unobstructed breath, which is similar to the inspiration portion of the breath shown in FIG. 6a. At any time during inhalation from this template (such as due to coughing, sighing, swallowing, and snoring), breaths that deviate by more than 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 the moving average of the first and this calibration point of the aforementioned inhalation events. This can be repeated at the same inhalation event at this second point, and so on. Therefore, 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 at these points is hereinafter referred to as "calibrated flow rate" and is expressed as Qs (t) . Alternatively, a single inspiration event may be used instead of a moving average.

From the calibrated flow, two form factors for the determination of the local blockage can be calculated.

The form factor 1 is the ratio of the average of the intermediate (for example, 32) calibrated flow points to the average of all (for example, 65) calibrated flow points. In cases where this ratio exceeds the unit, breathing will be considered normal. At ratios (Unity) or smaller, breathing is considered obstructed. A ratio of about 1.17 is used as the cut-off value between partial obstructive and obstructive breathing, and is equivalent to the degree of obstruction that allows the appropriate oxygen to be maintained in a typical user.

Form factor 2 is calculated as the RMS deviation from the unit calibrated flow rate, 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 limiting breathing. The closer the RMS deviation is to zero, the breathing will be considered a greater flow limitation.

Form factors 1 and 2 can be used as an alternative or in combination. In other forms of the technology, the number of sampling points, respirations, and intermediate points may differ from those described above. In addition, the critical value may be a value other than such a description.

No breath and low breath decisions (4325)

In one form of the technology, a processor (4230) executes one or more algorithms (4325) to determine whether there is no breathing and / or low breathing.

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

In one form, when the function of the respiratory flow Qr falls below a threshold value of the flow for a predetermined period of time, it can be said that no breathing has been detected. The function can determine a peak flow, a relatively short-term average flow, or a relatively short-term average and peak flow intermediate 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 Qr drops below a second flow threshold in a predetermined period of time, it can be said that a low breath has been detected. The function can determine a peak flow, a relatively short-term average flow, or a relatively short-term average and peak flow intermediate flow, such as RMS flow. The second flow threshold may be a relatively long-term measurement of the flow. The second flow threshold is greater than the flow threshold used to detect no breathing.

Allergic Rhinitis (4326)

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

In one form, the nasal snore algorithm (4326) receives a breathing flow signal Qr as an input and provides a measure of the degree of occurrence of nasal snore as an output.

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

Airway decision (4327)

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

In one form, the unobstructed airway algorithm (4327) receives a breathing flow signal Qr as an input, and determines the signal power in the frequency range of about 0.75 Hz and about 3 Hz. The peaks present in this frequency range are used to represent an open airway. The absence of a peak is used to indicate a closed airway.

In one form, the frequency range of the peak search is the frequency of the minimum forced oscillation of the therapeutic pressure Pt. In one implementation, the forced oscillation is a frequency of 2 Hz with an amplitude of about 1 cmH ₂ O.

In one form, the unobstructed airway algorithm (4327) receives a breathing flow signal Qr as an input and decides whether to present a cardiac signal. Cardiogenic signals are not presented to indicate closed airways.

Decision on treatment parameters (4328)

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

In one form of the 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)

Among them: ‧ A is the pressure support ‧ P (Φ) is the waveform value of the current value of the phase (in the range of 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 according to the parameters A and Po values. In some implementations of this form of the technology, the pressure support A is equal to zero, so the therapeutic pressure Pt is equivalent to the bottom pressure Po during the entire breathing cycle. This implementation is usually classified under the heading of CPAP treatment.

The bottom surface pressure Po may be a constant value, which may be a designated and / or manually input PAP device (4000). This alternative method is sometimes referred to as continuous CPAP treatment. Alternatively, the bottom pressure Po can be an indicator of one or more of the sleep apnea events (such as flow restriction, no breathing, low breathing, unobstructed, and nasal snore) returned by the individual algorithm of the treatment engine module (4320) Or as a function of measurement. This alternative method is sometimes called APAP treatment.

FIG. 4e is a flowchart illustrating a method (4500) implemented by the processor (4230) for continuously calculating the bottom pressure Po as an implementation part of the APAP treatment of the algorithm (4328). In this implementation, with equation (1), the treatment pressure Pt is equivalent to the bottom pressure Po .

The method (4500) starts from step (4520), in which the processor (4230) compares the measured value of the absence of breath / low breathing with a first threshold value, and determines whether the measured value of the absence of breathing / low breathing occurs at The first threshold has been exceeded for a predetermined period of time to indicate that no breathing / low breathing is occurring. If so, method (4500) executes step (4540); otherwise, method (4500) executes step (4530). In step (4540), the processor (4230) compares the measured value of airway patency with a second critical value. If the measured value of airway patency exceeds the second critical value, it means that the airway is open, the found aspiration / low breath is central, and method (4500) performs step (4560); otherwise, aspiration / low breathing is obstructive And method (4500) executes step (4550).

At step (4530), the processor (4230) compares the measured value of the flow limit with a third threshold value. If the measured value of the flow limit exceeds the third critical value, it means that the inspiratory flow is restricted, and the method (4500) executes step (4550); otherwise, the method (4500) executes step (4560).

In step (4550), the processor (4230) increases the bottom surface pressure Po by a predetermined pressure increase P , so that the generated treatment pressure Pt is not greater than an upper limit APAP pressure Pupper, which can 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 cmH ₂ O and as high as 3 cmH ₂ O, or as low as 0.5 cmH ₂ O and as high as ₂ cmH ₂ O. In other implementations, the maximum therapeutic cmH ₂ O pressure Pmax may be as low as 15 cmH ₂ O and as high as 35 cmH ₂ O, or as low as 20 cmH ₂ O and as high as 30 cm H ₂ O. The method (4500) then returns to step (4520).

In step (4560), the processor (4230) reduces the bottom surface pressure Po by a decrement, so that the generated treatment pressure Pt is not lower than the lower limit APAP pressure Plower , which can be set to a prescribed minimum treatment pressure Pmin . The method (4500) then returns to step (4520). In an implementation, the reduction is proportional to the Pt-Pmin value, so that Pt is exponentially reduced to the minimum treatment pressure Pmin in the absence of any events found. In one implementation, the ratio is set constant, so that the time constant of the exponential reduction of Pt is 60 minutes, and the minimum treatment pressure Pmin is 4 cmH 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 cmH ₂ O and as high as 8 cm H ₂ O, or as low as ₂ cmH ₂ O and as high as 6 cm H ₂ O. Alternatively, the decrease in the bottom surface pressure PO may be determined in advance, and Pt is reduced to a minimum treatment pressure Pmin in a linear manner without any event being found.

In one form of the technology, the predetermined pressure increment P is smaller than the previous implementation of the algorithm (4328) and the time constant is longer than its previous implementation. This type of difference that actually combines measurements of flow limitation, no breathing, low breathing, patency, and epistaxis is assessed in a single breath, rather than multiple breaths, combined with a control loop implemented with this form of method (4500) of the technology Lu provides a smoother implementation than the previous implementation of the algorithm (4328) and does not have "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 person who started the treatment, the patient (1000) is usually awake. Once the patient (1000) begins treatment (such as when the patient goes to bed first at night or returns to treatment after interruption of midnight sleep), 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 flawed.

Therefore, there is a need for a "bedtime mode" operation of the PAP device (4000) that can be implemented by a processor, such as a processor of a central controller (4230). The bedtime mode can wake up when the patient (1000) starts treatment and ends the treatment at an appropriate time, such as when the PAP device (4000) considers the patient (1000) to be asleep, and / or a predetermined time limit has elapsed. The purpose of the bedtime mode operation is to allow the patient (1000) to fall asleep at a lower or more comfortable pressure, because the patient (1000) does not need treatment when he is awake. The treatment pressure during the bedtime mode may be a second treatment and follow a bedtime mode in which the pressure is compared with time, which starts from the bedtime pressure Ps , which may be less than or even substantially lower than the minimum treatment pressure Pmin . The choice of bedtime mode should be consistent with the patient falling asleep. Bedtime pressure Ps can range from 2 to 6 cmH ₂ O, or from 3 to 5 cm H ₂ O, preferably about 4 cm H ₂ O.

After the end of bedtime mode, a "transition period" that may be implemented by a processor, such as a processor of a central controller (4230). During this transition, the PAP device (4000) can switch between the bedtime mode of operation and its selected treatment mode. During this transition, treatment stress follows a transition pattern of stress versus time. The transition mode is selected to increase the value of the treatment pressure Pt from the beginning of the transition period to a predetermined treatment pressure Pth with a minimum delay, but without the need to wake up the patient, so 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 may be a prescribed minimum treatment pressure Pmin . In other treatment modes (eg, stable CPAP), the treatment pressure Pth may be a prescribed continuous 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 function form that controls the parameters determined by individual parameters that instantiate the individual function 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 exponents, time constants, durations, slopes, coefficients, or combinations thereof. In some such implementations, either or both of the bedtime mode and the transition mode can be determined by controlling time parameters of the duration of the bedtime and the transition mode. In one example, the bedtime mode is illustrated as follows:

Among them, ps is the bedtime parameter in units of use time. According to equation (2), the bedtime mode is a linear increase in bedtime time parameter ps from bedtime pressure Ps to treatment pressure Pth . The transition time parameter can be selected to be substantially shorter than the bedtime parameter. 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 this specification, "substantially shorter" means shorter by a ratio between 5 and 50, or 10 and 40, or 20 and 30.

In other such implementations, one or both of the bedtime mode and the transition mode can be determined by the slope value (pressure versus time). In one example, the bedtime mode is illustrated as follows: Pt ( t ) = Ps + △ _ps t (3)

Where ps is the slope parameter before bedtime. According to equation (3), the bedtime mode is the slope ps before bedtime, a linear increase 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 cmH ₂ O / min, or 0.2 to 0.4 cmH ₂ O / min, or 0.25 to 0.35 cmH ₂ O / min. The transition time parameter may range from 0.5 to 10 cmH ₂ O / min, or 2 to 8 cmH ₂ O / min or 3 to 6 cmH ₂ O / min. In this 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 treatment pressure increase, known as the maximum upward swing rate. The maximum upturn rate can be as high as 0.25cmH ₂ O / sec.

FIG. 4f is a state diagram illustrating the initial stage of the operation (4600) of the treatment engine module (4320) in one form of the technology. According to the initial stage of the operation (4600), when the patient (1000) starts treatment, the PAP device (4000) enters the bedtime mode (4610). In an implementation, an initial signal is generated, that is, a treatment start signal input from the patient (1000) to the PAP device (4000) through the input device (4220). In another implementation, the start signal is a SmartStart signal generated by the processor (4230) in response to the ventilation decision algorithm (4323) detecting that the patient (1000) has started to wear the patient interface (3000) and / or is breathing. . This detection can be achieved by the processor (4230) in a conventional manner, for example, the disclosure of ResMed Limited's European Patent Application No. EP 661071 entitled "Device for Continuous Positive Airway Pressure (CPAP)". During the bedtime mode (4610), the processor (4230) initializes the treatment pressure Pt to the bedtime pressure Ps. The processor then controls the therapeutic pressure Pt pressure based on 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 start of falling asleep. The onset of falling asleep can be detected by any conventional method determined by the state of immediate sleep. In one implementation, falling asleep is found to occur if one or both of the following conditions occur:

‧ Multiple SDB events, such as flow restriction, no breathing, low breathing, or nasal discharge, within a first predetermined interval, as determined by measuring these quantities obtained above. For example, there are three or more obstructive apnea or hypopnea events in a two-minute interval; or five examples of epistaxis in five breath 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. In order to detect that there is no breathing disorder, the controller (4230) tests whether there is no ventilation at a second predetermined interval of one or more of the following breathing variables: o tidal volume; o inspiration time; o breathing rate; o peak inspiratory flow ; O Exhalation peak flow position; o Time since last breath.

If a sleep onset occurs and / or a timer reaches a timer limit (such as a timer limit, which is a function of bedtime parameters), the PAP device (4000) transitions from bedtime mode (4610) to a transition period (4620) ). In one implementation, the PAP device (4000) does not constitute a detection of whether or not a sleep onset has occurred. The transition from the set mode (4610) to the transition period (4620) is based on whether a timer has reached a timer limit or any other appropriate means. In one implementation, the timer limit is equal to the bedtime 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 starting 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 deliver treatment in the current mode of treatment according to equation (1). Treating compressed air, 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 before the timer limit expires. In this case, there is no pressure change in the transition period (4620), and the PAP device immediately enters the treatment mode (4630).

In one implementation, the bedtime pattern is a linear increase from bedtime pressure Ps to treatment pressure Pth (see FIG. 4j (b)). The slope of the linear increment can be the slope before bedtime, such as equation (3), or it can be selected so that the treatment pressure Pth is reached when no sleep onset is found, and the treatment pressure Pth reaches the bedtime time parameter, such as equation (2). In another implementation, the bedtime pattern is an exponential increase from bedtime pressure Ps to treatment pressure Pth . The exponential increase may have a time constant equal to the bedtime parameter. In another implementation, the duration of the bedtime pattern is equal to the bedtime pressure Ps for a duration equal to the bedtime pressure Ps (see Figures 4g and 4h). In yet another implementation, the bedtime mode is a series of linear increments separated by a "pause period" during a period of constant treatment pressure (see Figure 4i). While the PAP device (4000) is still in bedtime mode (4610), the pause period allows the patient (1000) to adopt a comfortable method to adapt to each pressure increase. The linearly increasing slope and duration, and the duration of the pause period can be selected, so that the treatment pressure Pth can be reached at the pre-sleep time parameter when the beginning of falling asleep is not found. Alternatively, the slope of the linear increment may be equal to the bedtime slope parameter, and the duration of the linear increment and the duration of the pause period may be determined in advance. When falling asleep is found to begin, the duration of the pause period decreases during the transition period (4620), as described below (see Figure 4i). In yet another implementation, the bedtime pattern is a series of linear increments that correspond to the inhalation 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 parts of each inspiratory cycle are detected by a phase determination algorithm (4321). The slope of the linear increment may 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 increase in the treatment pressure Pth . The slope of the linear increment may be a transition slope parameter, or may be selected such that the treatment pressure reaches the treatment pressure Pth at the transition time parameter (see FIG. 4g). In another implementation, the transition mode is a series of linear increments separated by a pause period while the treatment pressure is constant. The slope and duration of the linear increment may be the same as the corresponding implementation of the bedtime mode (4610). However, the duration of the pause period can be selected such that the treatment pressure reaches the treatment pressure Pth at the transition time parameter (see Figure 4i). The duration of the pause period can be zero seconds, which makes the transition mode equivalent to a continuous linear increment. In yet another implementation, the transition mode is a series of linear increments that correspond to the inhalation portion of each breathing cycle separated by the pause period, which inhalation portion corresponds to the exhalation portion of each breathing cycle (see Figure 4h) . The slope of the linear increment may be equal to the slope of the transition slope before bedtime. In addition to the above, other transition modes can be considered.

In the change of the initial stage of the 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 the soft APAP mode, the treatment control module (4320) delivers APAP treatment to the patient (1000). For example, by implementing the method (4500) (see FIG. 4e), the treatment pressure Pt is initialized to the bedtime pressure Ps . The lower limit APAP pressure Plower can be set to the treatment pressure Pth or the bedtime pressure Ps . The upper limit APAP pressure Pupper can be set to the specified maximum treatment pressure Pmax , or to the treatment pressure Pth. In this variation, the detection of the start of falling asleep may still cause the PAP device (4000) to transition from bedtime mode (4610) to a transition period (4620). In this change, the bedtime mode (4610) still has a bedtime time parameter, which can determine the timer limit for transitioning between the bedtime mode (4610) and the transition period (4620) when there is no onset of falling asleep as described above. This change also has an additional condition, which changes the PAP device (4000) from bedtime mode (4610) to a transition period (4620), that is, the treatment pressure Pt reaches the treatment pressure Pth before falling asleep or the timer expires. 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 that, the pressure limits Plower and Pump can be set to Pmin and Pmax , as described above. In this variation, APAP treatment is provided to the patient (1000) during bedtime mode (4610), although at a treatment pressure that is less than the treatment pressure Pth (hence the name "soft APAP" mode). If the lower limit APAP pressure Plower is set to the treatment pressure Pth , then the reduction step (4560) does not allow the reduction pressure to be lower than Plower , so avoid reducing the treatment pressure Pt during the bedtime mode (4610). This allows the treatment pressure Pt to reach the treatment pressure Pth faster, and therefore quickly enters the treatment mode (4630).

In yet another change in the initial stage of operation (4600), the transition period (4620) does not follow a predetermined pressure time pattern, but includes a soft APAP mode, where the treatment control module (4320) delivers APAP treatment to the patient ( 1000), for example, by implementing the method (4500) (see FIG. 4e), which terminates in the bedtime mode (4610), the treatment pressure Pt is initialized to the treatment pressure Pt 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 to the treatment pressure Pth . Just like the initial mode of the above operation (4600) related to FIG. 4f, the transition period (4620) continues until the treatment pressure reaches the treatment pressure Pth, at which time the PAP device (4000) enters the treatment mode (4630). There is also an additional situation that causes the PAP device (4000) to transition from the transition period (4620) to the treatment mode (4630), that is, a timer limit determined by the transition time parameter expires. If the lower limit APAP pressure Plower is set to the treatment pressure Pth , then the reduction step (4560) does not allow the reduction of the treatment pressure to be lower than the Plower , so avoid reducing the treatment pressure Pt during the transition period (4620). This allows the treatment pressure Pt to reach the treatment pressure Pth faster, and therefore, enter the treatment mode faster (4630).

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

In Figure 4g, the solid trace (4700) and the dashed trace (4730) represent the treatment pressure Pt as a function of time in different pre-sleep situations. The solid line trace (4700) and the dotted line trace (4730) during the bedtime mode follow the bedtime mode of continuous pressure at bedtime pressure Ps, which in this example has a value of 4 cmH ₂ O. In the scenario represented by the solid line trace (4700), the beginning of falling asleep is detected at 10 minutes. At time (4710), the solid line trace (4700) will follow a linear increase within the 2 minute transition time parameter. The transition mode (4720) from the measurement to the minimum treatment pressure Pmin is 10 cmH ₂ O in this example, and corresponds to a slope of ₃ cmH ₂ O / min. In the scenario represented by the dashed trace (4730), the start of falling asleep was not detected, but instead, the timer limit for the duration of the bedtime parameter equal to 28 minutes was reached. At time (4740), the solid trace (4700) Within a 2 minute transition time parameter, follow the transition mode (4750) that linearly increases to the minimum treatment pressure Pmin , which is equivalent to a slope of ₃ cmH 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 onset of falling asleep is detected at 10 minutes. At time (4770), the trace (4760) during the inhalation part of each breathing cycle, linearly increases to the transition mode of the minimum treatment pressure Pmin (4780), and at During the expiratory part of each breathing cycle, there is continuous pressure. In this example, each of the inhalation part and the exhalation part of each breathing cycle lasts 1 second. The slope of the linear increment is set so that the treatment pressure Pt reaches the minimum treatment pressure Pmin within a transition time parameter of 7 seconds, which is equivalent to a slope of 1 cmH ₂ O per breath.

In Figure 4i, the trace (4790) represents the treatment pressure Pt over time. The trace during the bedtime mode (4790) follows a series of linearly increasing bedtime modes (4791) with a slope of 1 cmH ₂ O per minute with a duration of 1 minute. During the period when 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 so that the treatment pressure Pt will reach the minimum treatment pressure Pmin at the time of 21 minutes before bedtime is detected. In this example, 10 cmH ₂ O. The onset of falling asleep is detected at 14 minutes. At time (4792), the trace (4790) follows a series of linearly increasing transition patterns (4794) equal to a slope of 1 cmH ₂ O per minute, and the duration of 1 minute is While the treatment pressure is constant, a 3-minute pause period is inserted. The slope and duration of the linear increment are the same as in bedtime mode, ie 1 cmH ₂ O per minute and 1 minute. The duration of the pause period is selected to be 1 minute so that the treatment pressure Pt reaches the minimum treatment pressure Pmin at a 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 "waking" sleep state (4810), and a later more stable phase, at about 400 After a few seconds, it corresponds to the "sleeping" sleep state (4820). In Figure 4j (b), the trace (4830) represents the treatment pressure Pt over time. The trace (4830) during bedtime mode usually corresponds to the "wake up" state (4810), which follows a linear increase from bedtime pressure Ps (equal to 4cmH ₂ O in this example) to a minimum treatment pressure Pmin of 7cmH ₂ O Bedtime mode (4840), the slope of which is set to 0.1cmH ₂ O per minute, so that Pt will start without detecting any falling asleep, and the bedtime time parameter will reach Pmin at 30 minutes.

The detection of falling asleep during bedtime mode is a transition between the "waking" state (4810) and the "sleeping" state (4820). The Pt trace (4830) follows a linear increase to the minimum treatment pressure Pmin In the transition mode (4850), the slope is set to ₂ cmH ₂ O per minute, so that the transition time parameter of Pt will reach Pmin in 1 minute, which is substantially shorter than the bedtime time parameter of 30 minutes. The dashed line (4860) represents the continuity of the bedtime pattern (4840), rather than actually following it, because of the detection of the beginning of falling asleep.

In FIG. 4k, the trace (4870) represents the treatment pressure Pt over time, wherein the bedtime mode (4610) is a soft APAP mode, the bedtime pressure Ps is set to 4cmH ₂ O, and the treatment pressure Pth is set to 10cmH ₂ O. The patient (1000) begins an event at time (4875), causing the therapeutic pressure Pt to rise. Further events cause the therapeutic pressure Pt to occasionally increase until the therapeutic pressure Pt reaches the therapeutic pressure Pth at time (4880). Note that the treatment pressure Pt does not decrease between times (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 .

Variation of the treatment parameter determining algorithm (4328)

In the modification of the treatment parameter determination algorithm (4328), the minimum treatment pressure Pmin that maintains the treatment pressure Pt (even without any indication of an SDB event) is not fixed, but can be based on the number of important events Na that occur in a predetermined interval Ta. Adjustment. That is, if Na or more important events occur within the interval of Ta seconds, Pmin will increase in increments of Pmin . In one implementation of a variation of the algorithm (4328), an important event is an SDB event such as flow restriction, no breathing, low breathing, or epistaxis, as determined from the measurement of these quantities obtained above. In one example, Pmin is predetermined at 1 cmH ₂ O, Na is 3, and Ta is 2 minutes. In other implementations, Pmin is determined in advance from other values in the range of 0.2 to 4 cmH ₂ O, or 0.5 to ₂ cmH ₂ O. In other implementations, Ta is determined in advance from other values ranging from 30 seconds to 10 minutes, or from 1 to 4 minutes.

In still other implementations of this variant of the treatment parameter determination algorithm (4328), the increment Pmin is not determined in advance, 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.

In some implementations of this variation of the treatment parameter determination algorithm (4328), Pmin maintenance is less than or equal to an upper limit Pmin_max, such as 10 cmH ₂ O. In other implementations, there is no such upper limit for the Pmin value. In one implementation, the important event is an SDB event.

In one implementation, Pmin does not increase during the bedtime cmH ₂ O mode (4610) or transition period (4620) described above with respect to FIG. 4f, regardless of whether an important event occurs.

FIG. 41 includes diagrams illustrating the operations of different implementations of the treatment parameter determination algorithm (4328) implemented by the treatment engine (4320) of FIG. 4d. In FIG. 41 (a), the dotted trace (4950) and the solid trace (4940) respectively represent the treatment pressure Pt (that is, a current pressure) and the minimum treatment pressure Pmin over time from 300 to 1300 seconds. In FIG. 41 (b), the trace (4900) represents the respiratory flow Qr at 300 to 700 seconds at any time, which shows two SDB events, namely, the first non-breathing (4910) and the second non-breathing (4920). Occurs between 400 and 450 seconds; and a third no breath (4930), which occurs about 530 seconds. The treatment pressure Pt dashed trace (4950) starts at 4cmH ₂ O equal to Pmin and increases at position (4960) after the first no breath (4910); again at position (4960) after the second no breath (4920) ) Increases and again at position (4980) after the third no breath (4930). The minimum treatment pressure Pmin increases from 4cmH ₂ O to the current value of the treatment pressure Pt, which is 7cmH ₂ O at the position (4970) after the second no breath (4920), which will be detected within a 2-minute interval Second no breathing (Na = 2, Ta = 120 seconds). In the absence of any subsequent SDB events, the treatment pressure Pt gradually decreases to the (incremental) value of Pmin, which is 7 cm H ₂ O, reaching Pmin after about 1250 seconds. In alternative implementations of the technology, Na and Ta may be different from 2 and 120 seconds, respectively. For example, two non-breathing within 1 minute, three non-breathing within 2 minutes, and five non-breathing within 5 minutes can alternately or additionally cause automatic adjustment to the minimum treatment pressure Pmin . In another alternative implementation, reducing the treatment pressure Pt when the treatment pressure Pt is below a predetermined threshold. The predetermined threshold may be equal to a specified minimum treatment pressure.

More generally, a PAP device (4000), which constitutes a variant implementation of the above-mentioned treatment parameter determination algorithm (4328), will automatically adjust the treatment within a range of pressure values, wherein the pressure range is based on the detection of a Or multiple breathing events It is determined automatically. In one form, the amount of pressure change (eg, increasing the amount of pressure) is a function of the pressure at which the event was detected.

In a further variant implementation of the treatment parameter determination algorithm (4328), if no or low breath is detected, for example, in step (4520) of method (4500), the treatment parameter determination algorithm (4328) does not check for airway clearance to Decide if apnea / hypopnea is obstructive or central, as in step (4540) of method (4500). However, the processor (4230) checks the current value of the mask pressure Pm . If the mask pressure Pm is greater than or equal to a threshold value Pthreshold , the aspiration / low respiration is inferred as a central aspiration / low respiration; otherwise, the aspiration / low respiration is inferred as an obstructive aspiration / low breath. This inference is based on physiological observations that apnea / low respiration occurring at higher mask pressure Pm is more likely to be central rather than obstructive. A further difference is that it is simpler than the above method (4500) and operates with substantially similar effectiveness. In one example, the threshold Pthreshold is 10 cmH ₂ O. In other implementations, the threshold value Pthreshold is as low as 5 cmH ₂ O or as large as 20 cmH ₂ O, or as low as 8 cmH ₂ O or as large as 15 cm H ₂ O.

Control module (4330)

A treatment control module (4330) according to one aspect of the technology receives a treatment parameter as an input from a treatment engine module (4320), and controls the treatment device (4245) to deliver air flow according to the treatment parameter.

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

Detect fault conditions (4340)

In one form of the 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 the presence of components

‧Operating parameters fall outside the recommended range (e.g. pressure, flow, temperature, PaO2)

‧ Cannot generate test alarms that can detect alarm signals.

After a fault condition is found, the corresponding algorithm issues a fault by one or more of the following:

‧ Beginning of audible, visual and / or dynamic (e.g. oscillating) alarms

‧Send messages to external devices

‧Record events

Humidifier (5000)

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

Vocabulary

For the purpose of this technical disclosure, in a particular form of the technology, it may be applied One or more of the following definitions. In other forms of the technology, other definitions may apply.

General

Air: In certain forms of the technology, air can be used to mean atmospheric air, and in other forms of the technology, air can be used to mean some other combination of breathable gases, such as atmospheric air with oxygen.

Positive Airway Pressure (PAP) treatment: Continuous positive air pressure in the atmosphere applies a supply of air to the inlet of the airway.

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

Continuous Positive Airway Pressure (CPAP) therapy: Positive pressure airways that treat the pressure approximately constant during the patient's breathing cycle. In some forms, the pressure at the airway inlet will change by a few centimeters of water during a single breathing cycle, such as 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 therapeutic pressure of automatic positive airway pressure can be continuously adjusted between the minimum and maximum limits, depending on whether there is an indication of an SDB event.

The appearance of PAP devices

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, airway can be associated with The outlet of the pneumatic block is fluidly connected to the patient interface. The airway may be referred to as an air duct. In some cases, there may be individual limbs for the inhalation and exhalation channels. In other cases, a single limb is used.

Blower: A piece of air that conveys a stream of air at a pressure exceeding atmospheric pressure.

Controller: A device or part of a device whose output is adjusted based on input. For example, one form of the controller has a variable under control, that is, the control variable, which constitutes the input of the device; and a set point of the related 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 converter may 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, strength sensors, motion sensors, noise sensors, breathing Scanner and camera.

Respiratory cycle appearance

Apnea: Preferably, apneas occur when the flow is below a predetermined threshold for a duration of, for example, 10 seconds. An obstructive apnea occurs when the airway does not allow air flow to be blocked (regardless of the patient's effort). A central apnea occurs when there is no apnea in the hairline due to reduced or no breathing effort.

Breathing Rate: The patient's natural breathing rate, which is usually measured in units of breaths per minute.

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

Breathing Effort: It's best to breathe. Breathing is natural breathing. People try to breathe.

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

Flow Limitation (Flow Limitation): Preferably, flow limitation is the state of a patient's breathing event when the patient's increased effort does not cause an increase in relative flow. A situation where flow restriction occurs during the inspiratory portion of the breathing cycle can be described as inspiratory flow restriction. The situation where flow restriction occurs in the exhaled part of the breathing cycle can be described as expiratory flow restriction.

Hypopnea: It is best. Low breathing means a decrease in flow but not a stop of flow. In one form, hypopnea occurs when the decrease in flow over a period of time is below a critical value. In one form of adult, one of the following can be considered hypopnea: (i) a 30% reduction in patient's breathing for at least 10 seconds plus 4% associated desaturation; or (ii) a reduction in patient's breathing for at least 10 seconds (but (Less than 50%), with at least 3% associated satiety or or arousal.

Inhalation part of the breathing cycle: Preferably, the period from the start of the inspiratory flow to the beginning of the expiratory flow is the inhalation part of the breathing cycle.

Airway Patency: The degree of airway opening, or the range of airway opening. An open airway is open. Airway patency 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 an end-expiratory pressure in the lungs that exceeds the atmospheric pressure.

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

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

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

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

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

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

Typical Recent Ventilation: The value of ventilation, which is the current value that tends to be dense after some predetermined time scale, that is, the measurement of the central tendency of the recent value of ventilation.

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

Ventilation ( Vent ): A measurement of the total volume of air exchanged by the patient's respiratory system, including inspiratory and / or expiratory flow per unit time. When expressed in units of "volume per minute", this amount is often referred to as "minute ventilation volume". The minute ventilation volume is sometimes expressed in terms of volume only, and is known as "volume per minute".

PAP device parameters

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

Leak: Ideally, "leak" is interpreted as the inflow of air into the day and week environment. Leakage may be intended (e.g.) exhaled gases CO _2. Leaks may be unintended, for example, caused by an incomplete seal between the nasal mask and the patient's face.

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

Anatomy of the respiratory system

Diaphragm: Muscles that extend across the bottom of the thorax. The diaphragm separates the thoracic cavity from the abdominal cavity, including the heart, lungs, and ribs. When the diaphragm is contracted, the volume of the chest increases and air is introduced into the lungs.

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

Lung: The human respiratory organ. The conductive areas of the lung include the trachea, bronchi, bronchioles, and terminal bronchioles. The breathing zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

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

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

Other statements

Part of the exposure 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 disclosure appears in the Patent and Trademark Office patent file or records, but retains all copyrights.

Unless the context clearly indicates otherwise, and many values are provided, it should be understood that the middle value of each tenth of the lower unit between the upper and lower limits of the range, and any other description or range described herein Intermediate values are included in the technical range. The upper and lower limits of these intermediate ranges (which can be independently included in the intermediate range) are also included in the technology and are subject to any specifically excluded limits within the described range system. Wherein, the scope includes one or both of the limitations, and the scope excluding any one or both of the included limitations is also included in the technology.

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

Unless defined otherwise, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art. Although any methods and objects similar or equivalent to those described in this specification can also be used in the practice or testing of the technology, this description describes limited exemplary methods and objects.

When a particular article is considered best to constitute a component, a clear substitute article with similar characteristics may be used as a substitute. In addition, unless specifically stated otherwise herein, any and all components discussed in this specification should be understood to be manufacturable and can also be made together or separately.

It must be noted that, as used in the scope of the present invention and subsequent patent applications, unless specifically stated herein, the quantifiers "a" and "the" imply plural meanings.

All publications discussed in this specification are incorporated by reference and describe the methods and objects of the subject matter of these publications. The publications discussed in this specification are provided solely to disclose publications prior to the filing date of this application, and should not be construed as an admission that the present invention is not entitled to antedate such disclosure by virtue of prior invention. In addition, the publication date provided may differ from the actual publication date, which may require individual confirmation.

Moreover, in terms of explaining the present invention, all terms shall be interpreted in the most reasonable manner consistent with this specification. In particular, the terms "including" and "comprising" will be interpreted non-exclusively as reference elements, components or steps, pointing out elements, components or steps that may be referenced, or pairing or combining other elements not explicitly mentioned, Components or steps.

The headings used in the embodiments are included only for easy reference by the reader, and are not the subject matter for limiting the scope of the present invention or subsequent patent applications. The subject matter should not be used to limit the scope of patent applications after the filing.

Although the technology has been described herein with reference to specific specific embodiments, it should be understood that these specific embodiments are merely illustrative of the principles and applications of the technology. In some examples, terms and symbols may imply that no particular details are required to implement the technology. For example, although the prepositions "first" and "second" may be used, unless otherwise specified, no order is specified, but it can be used to distinguish different elements. In addition, although the processing steps in a method can be described or illustrated in order, this order is not necessarily required. Those skilled in the art should understand that this sequence can be modified and / or its appearance can be performed simultaneously or even simultaneously.

Therefore, it should be understood that many modifications can be made to the specific embodiments illustrated and other configurations can be designed without departing from the spirit and scope of the technology.

Claims (32)

A device for treating respiratory disorders, comprising: a pressure device; and a controller including at least one processor, the controller is configured to perform: a bedtime mode in which pressure is compared with time when treatment is started Under a treatment pressure, control the pressure device to supply the pressurized air flow to the patient's airway; detect the patient's onset of falling asleep by detecting the following conditions: lasting for a predetermined interval with little or no breathing disorder, When detecting the start of falling asleep of the patient, the pressure device is controlled to increase the treatment pressure to a predetermined treatment pressure according to a transition mode of pressure to time comparison; and the pressure device is controlled to treat the pressure device under a treatment pressure. The pressurized air flow is supplied to the airway of the patient. The device according to claim 1, wherein the bedtime mode is determined by the processor according to a bedtime parameter, and according to a transition time mode, the processor determines the transition mode, and wherein the transition The time parameter is substantially shorter than the bedtime time parameter. The device according to claim 2, wherein the bedtime mode is a constant value, and the constant value is equal to the bedtime pressure during the duration equal to the bedtime time parameter. The device according to claim 2, wherein the bedtime mode is a linear increment, and the selected slope is such that the detection of the pressure before falling asleep will reach the therapeutic pressure at the bedtime time parameter. The device according to claim 2, wherein the bedtime mode is a series of linear increments separated by a pause period during a constant pressure period, wherein the slope and duration of the linear increment are related to the duration of a pause period It is selected so that when the detection is started without falling asleep, the pressure will reach the therapeutic pressure at the pre-sleep time parameter. The device according to 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 therapeutic pressure at the transition time parameter. The device according to any one of claims 2 to 5, wherein the transition mode is a series of linear increments separated by a pause period during a constant pressure period, wherein the slope and duration of the linear increment and the linear increment The duration of the pause period is selected such that the pressure reaches the therapeutic pressure at the transition time parameter. The device according to claim 1, wherein the bedtime mode is determined by the processor according to a bedtime slope, the transition mode is determined by the processor according to a transition slope, and wherein the transition slope is substantial Higher than this bedtime slope. The device according to claim 8, wherein the bedtime mode is a constant value which is equal to a bedtime pressure. The device according to claim 8, wherein the bedtime pattern is a linear increment of a slope, which is equal to the bedtime slope. The device according to claim 8, wherein the bedtime mode is a series of linear increments separated by a pause period during a constant pressure period, wherein a slope of the linear increment is equal to the bedtime slope. The device according to claim 8, wherein the bedtime mode is a series of linear increments that correspond to the inhalation part of each breathing cycle, and the linear increments are separated by a pause period, which remains unchanged under pressure The period corresponds to the exhalation portion of each breathing cycle, where the slope of the linear increment is equal to the bedtime slope. The device according to any one of claims 8 to 12, wherein the transition mode is a linear increment with a slope equal to the transition slope. The device according to any one of claims 8 to 12, wherein the transition mode is a series of linear increments separated by a pause period during a constant pressure period, wherein the slope of the linear increment is equal to the transition slope . The device according to any one of claims 8 to 12, wherein the transition mode is a series of linear increments that correspond to the inhalation portion of each breathing cycle, and the linear increments are separated by a pause period, which The exhalation portion of each breathing cycle is consistent during the period when the pressure remains constant, where the slope of the linear increment is equal to the transition slope. The device according to any one of claims 1 to 5 or 8 to 12, wherein the controller is further configured to control the pressure device so that when a predetermined timer limit expires, the treatment pressure is based on the transition mode. Increase to this predetermined treatment pressure. The device according to any one of claims 1 to 5 or 8 to 12, wherein the treatment pressure is the predetermined treatment pressure. The device according to any one of claims 1 to 5 or 8 to 12, wherein the treatment pressure is changed according to the occurrence of a sleep disordered breathing event. A method for treating a breathing disorder, the method comprising: when starting treatment, supplying the pressurized air flow to a patient's airway under a treatment pressure according to a bedtime pattern in which pressure is compared with time; by detecting the following Condition to detect the patient's onset of falling asleep: lasting for a predetermined interval with little or no breathing disorder, when detecting the beginning of falling asleep of the patient, increase the treatment pressure to a predetermined treatment according to a transition pattern of pressure and time comparison Pressure; and supplying the pressurized air stream to a patient's airway under a therapeutic pressure. A device for treating respiratory disorders includes: a pressure device; and a controller including at least a processor, the controller is configured to control the pressure device: a treatment pressure starting from the pressure before bedtime when the treatment is started Next, the pressurized air flow is supplied to the airway of the patient, and changes according to the occurrence of a sleep apnea event; when the patient starts to fall asleep, the treatment pressure is increased according to a pressure-to-time transition mode To a predetermined treatment pressure; and to supply the pressurized air stream to the patient's airway under a treatment pressure; wherein the controller is configured to detect by detecting that there is little or no breathing disorder for a predetermined interval, Detects the patient's onset of falling asleep. The device according to claim 20, 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 according to claim 20 or 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 the treatment pressure reaches the predetermined treatment pressure . The device according to claim 20 or 21, wherein the treatment pressure is changed according to the occurrence of the sleep and breathing disorder events to avoid reducing the treatment pressure. The device according to claim 20 or 21, wherein the treatment pressure is changed between a predetermined pre-sleep pressure and the predetermined treatment pressure according to the occurrence of the sleep apnea event. A method for treating a breathing disorder, the method comprising: when starting treatment, supplying the pressurized air flow to a patient's airway under a treatment pressure starting from a pre-sleep pressure, and according to the sleep breathing disorder The occurrence of the event changes; the detection of the patient's onset of falling asleep by detecting that there is little or no breathing disturbance for a predetermined interval; when detecting the beginning of falling asleep of the patient, according to a transition pattern of pressure and time comparison, the The treatment pressure is increased to a predetermined treatment pressure; and the flow of pressurized air is supplied to a patient's airway under a treatment pressure. A device for treating respiratory disorders includes: a pressure device; and a controller including at least one processor, the controller is configured to control the pressure device to perform the following: when starting treatment, according to a pressure and The bedtime mode of time comparison supplies the pressurized air flow to the patient's airway under a treatment pressure; when the patient's onset of sleep is detected, the treatment pressure is adjusted according to the occurrence of a sleep disordered breathing event; and when When the treatment pressure reaches a predetermined treatment pressure, the pressurized air flow is supplied to the airway of the patient, wherein the controller is configured to detect the patient's condition by detecting that there is little or no breathing disorder for a predetermined interval. Beginning to fall asleep. The device according to claim 26, wherein the controller is further configured to control the pressure device to supply the pressurized air flow to the patient's airway under the treatment pressure when a predetermined timer limit expires. The device according to claim 26 or 27, wherein the controller is configured to control the pressure device to adjust the treatment pressure according to the occurrence of a sleep disordered breathing event to avoid reducing the treatment pressure. The device according to claim 26, wherein the controller is configured to control the pressure device to adjust the treatment pressure to be lower than the predetermined treatment pressure according to the occurrence of a sleep disordered breathing event. A method for treating a breathing disorder, the method comprising: when starting treatment, supplying the pressurized air flow to a patient's airway under a treatment pressure according to a bedtime pattern in which pressure is compared with time; by detecting Detecting the beginning of falling asleep for a predetermined interval with little or no breathing disorder; when detecting the beginning of falling asleep of the patient, adjusting the treatment pressure according to the occurrence of a sleep breathing disorder event; and when the treatment pressure reaches a predetermined treatment When under pressure, this pressurized air flow is supplied to the patient's airway under a therapeutic pressure. The device of any of claims 1, 20, and 27, wherein detecting that there is little or no breathing disorder for a predetermined interval comprises evaluating one or more of the following breathing variables: inspiratory time, position of peak expiratory flow, Time since last breath. The method of any one of claims 19, 25, and 30, wherein detecting that there is little or no breathing disorder for a predetermined interval includes evaluating one or more of the following breathing variables: inspiratory time, position of peak expiratory flow, Time since last breath.