Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/06—Respiratory or anaesthetic masks
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Measuring devices for evaluating the respiratory organs
  • A61B5/087—Measuring breath flow
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Measuring devices for evaluating the respiratory organs
  • A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4806—Sleep evaluation
  • A61B5/4818—Sleep apnoea
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4833—Assessment of subject's compliance to treatment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes with alarm devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0057—Pumps therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0057—Pumps therefor
  • A61M16/0063—Compressors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes operated by electrical means
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
  • G01F1/00—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow
  • G01F1/05—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using mechanical effects
  • G01F1/34—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using mechanical effects by measuring pressure or differential pressure
  • G01F1/36—Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using mechanical effects by measuring pressure or differential pressure the pressure or differential pressure being created by the use of flow constriction
  • G01F1/40—Details of construction of the flow constriction devices
  • G01F1/44—Venturi tubes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
  • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
  • A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/35—Communication
  • A61M2205/3546—Range
  • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/35—Communication
  • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
  • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
  • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/82—Internal energy supply devices
  • A61M2205/8206—Internal energy supply devices battery-operated

Definitions

• the present invention relates to an apparatus for monitoring the observance of a treatment of obstructive sleep apnea.
• the obstruction that occurs during sleep has two main causes that are lack of muscle tone and heaviness.
• the excessive presence of tissues in the upper airways and anatomical deformities exacerbate the consequences of these factors.
• the body relaxes and muscle tissue, such as tongue and soft palate, for example, lose their rigidity.
• the effect of gravity pushes these tissues towards the back of the throat, which closes the upper airways.
• each obstruction deprives the body of oxygen and therefore forces it to keep carbon dioxide (C0 2 ) that it would expel normally during the expiration phases. It follows that the gas balance of the blood is disrupted and the body is exposed to a "toxic" environment. When the body "signals” that it needs more oxygen, the brain wakes up the sleeper, breathing resumes and the person goes back to the next obstruction.
• These obstructions also cause an increase in heart rate and blood pressure, and eventually weaken the body's "automatic” response capacity, resulting in more and more severe apneas and hypopneas.
• Symptoms of sleep deprivation in people with OSA include excessive daytime sleepiness, lack of concentration, poor memory, and even depressive mood.
• High blood pressure and low blood oxygen levels are common symptoms for people with sleep apnea, but these are difficult symptoms to detect.
• There are other more easily identified symptoms such as daytime sleepiness, snoring, apnea or irregular breathing during sleep, loss of concentration.
• Effective treatment of OSA involves applying positive air pressure to the patient's airways. The air pressure acts as an "air cushion" that keeps the upper airways open and prevents apnea.
• CPAP treatment is an effective treatment for OSAS patients if its application is well followed. It can then lead to a clear improvement in the quality of life of the patient. On the other hand, the effects of the treatment are negligible, or even nil, if the patient does not observe his treatment for at least 4 hours per night.
• Knowing the patient's compliance, ie measuring the actual time during which they are following their treatment is therefore essential. Similarly, knowing in real time the effectiveness of treatment is a valuable aid to adjust the prescription treatment by the attending physician.
• Document WO-A-2009136101 discloses a device for monitoring the observance of an obstructive sleep apnea treatment comprising an air flow sensor circulating in the patient circuit.
• WO-A-2011/067300 proposes an apparatus for monitoring a respiratory parameter of a patient comprising a convergent / divergent device and a pressure measurement system making it possible to measure the pressure between two portions of said convergent / divergent device having different sections.
• a similar apparatus is described in US-A-2004/0167419.
• the document EP-A-2017586 teaches a monitoring device for CPAP type breathing apparatus comprising a pressure measurement system for measuring the pressure in a duct conveying air under pressure, which duct passes through said device.
• the present invention aims to improve the devices for monitoring the compliance of an oxygen therapy treatment incorporating a venturi so as to allow a measurement as as accurate and sensible as possible of the gas flow by minimizing the pressure drop resulting from the passage of the gas into the venturi.
• the solution of the present invention thus relates to a device for monitoring the observance of a treatment of obstructive sleep apnea comprising a gas passage and a venturi having a cylindrical inlet and outlet, said venturi being arranged axially in said gas passage, a first pressure sensor and a second pressure sensor, characterized in that the inlet and the outlet of the venturi have diameters D1 between 10 and 25 mm, and the venturi comprises, arranged successively between said inlet and outlet, a convergent portion in the shape of an arc of a circle, a cylindrical neck of diameter less than the diameter D1 of the inlet, and a diverging portion characterized by an angle of divergence of between 5 ° and 15 °, and in which the diameter D2 of the neck of the venturi is between 5 and 15 mm, and the length L2 of the neck of the venturi is between 3 and 12 mm.
• the venturi of the invention makes it possible to achieve an accurate and reliable measurement of the flow flowing in the gas passage. Indeed, knowing that the gas flow rate is proportional to the root of the gas pressure drop between the inlet and the neck of the vacuum device, thanks to the venturi of the invention and its particular geometry, the pressure drop between the Venturi inlet (sensor) and the Venturi neck is sufficient to obtain a flow measurement accurate enough to detect respiratory events in the patient but, conversely, low enough not to affect the treatment of the patient, that is, no more than 0.2 cm H 2 0 of output pressure loss for a normal use rate of about 70 1 / min.
• the venturi is designed to obtain a pressure loss of less than 80 Pa for the flow range in question, thanks to its particular geometry, especially the selection of the diameter D2 of the neck between 5 and 15 mm and its length. L2 between 3 and 12 mm, can limit the pressure drop in the patient circuit and thus minimize the impact on the treatment of the patient while maintaining a sufficient sensitivity to allow the measurement of compliance with this treatment as well as the detection of residual respiratory events.
• venturi associated with the pressure sensors allows both to obtain a better sensitivity of detection of respiratory events and to minimize the disturbance of the treatment.
• the venturi of the invention is designed to limit the pressure loss of the gas between said inlet and outlet, that is to say so as to have a loss of pressure, between its inlet and its outlet, less than 100. Pa for a gas flow in the passage between 110 and 150 liters per minute. Preferably, this pressure loss is less than 80 Pa.
• the venturi is of the nozzle type. This geometry of the venturi is in accordance with the aforementioned ISO 5167-3 standard, and has the advantage of allowing a low pressure loss of the gas while ensuring a good stability of the gas flow.
• the apparatus according to the invention may comprise one or more of the following characteristics:
• the inlet and outlet have an identical diameter of between 13 and 20 mm, preferably between 16 and 18 mm.
• the inlet and the outlet are of cylindrical shape and have diameters D1 identical, preferably between 16 and 18 mm.
• the diameter D1 is adapted to the output diameter of the air generator of the CPAP treatment apparatus. More preferably, the diameter D1 of the inlet of the venturi is equal to about 17.3 mm.
• the venturi comprises a convergent portion having a profile formed by two successive arcs of circles
• the angle of divergence a is less than or equal to 12 °, preferably less than or equal to 10 °, advantageously equal to approximately 8 °.
• the diameter D 2 of the neck of the venturi is between 7 and 13 mm, preferably between 9 and 11 mm, advantageously equal to about 10 mm.
• the choice of the diameter of the neck and the angle of divergence allows a good compromise between the decrease of the pressure loss in the venturi and the increase of its sensitivity of detection.
• the length L2 of the neck is between 5 and 10 mm, preferably of the order of 7 to 8 mm, in particular equal to about 7.5 mm.
• the venturi comprises a convergent portion having a profile formed by a first arc of first radius R1 and a second arc of circle of second radius R2 in which the said first and second radii are less than 10 mm, preferably smaller than at 5 mm.
• the venturi has a total length of between 90 and 100 mm.
• a first pressure sensor positioned at the inlet of the venturi for measuring the pressure of the gas at the inlet of the venturi; and a second pressure sensor positioned at the neck of the venturi to measure the pressure of the gas at the neck of the venturi.
• first additional pressure sensor provided at the inlet of the gas passage and measuring the absolute pressure of the gas at the connection with the air generator of the PPC treatment device and / or a second sensor of additional pressure provided at the outlet of the gas passage and measuring the absolute pressure at the connection with the air duct bringing air to the mask of the patient.
• processing means able to process the measured flow rate and pressure values in order to deduce therefrom at least one processing time datum and at least one treatment efficiency datum.
• the processing means may comprise means for correcting possible measurement errors due, for example, to variations in temperature and / or pressure and / or humidity in the air.
• data storage means arranged to store at least one of said data.
• the user further comprises one or more indicators, such as colored LEDs, for example red and green, providing the user with information relating to the effectiveness of the treatment.
• indicators such as colored LEDs, for example red and green

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• Pulmonology (AREA)
• Physics & Mathematics (AREA)
• Biophysics (AREA)
• Pathology (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• Emergency Medicine (AREA)
• Hematology (AREA)
• Anesthesiology (AREA)
• Physiology (AREA)
• Fluid Mechanics (AREA)
• General Physics & Mathematics (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

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• 2011
  • 2011-02-24 FR FR1151484A patent/FR2971930B1/fr not_active Expired - Fee Related
• 2012
  • 2012-01-11 CN CN2012800101533A patent/CN103391793A/zh active Pending
  • 2012-01-11 JP JP2013554926A patent/JP2014508595A/ja active Pending
  • 2012-01-11 US US14/001,124 patent/US20130331726A1/en not_active Abandoned
  • 2012-01-11 WO PCT/FR2012/050072 patent/WO2012114004A1/fr not_active Ceased
  • 2012-01-11 CA CA2823861A patent/CA2823861A1/fr not_active Abandoned
  • 2012-01-11 EP EP12705319.7A patent/EP2678061A1/fr not_active Ceased
  • 2012-01-11 AU AU2012220479A patent/AU2012220479A1/en not_active Abandoned

Non-Patent Citations (3)

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