EP2941186A1 - Device having a heat-sensitive cell for monitoring the observance of a medical treatment - Google Patents

Device having a heat-sensitive cell for monitoring the observance of a medical treatment

Info

Publication number
EP2941186A1
EP2941186A1 EP13791849.6A EP13791849A EP2941186A1 EP 2941186 A1 EP2941186 A1 EP 2941186A1 EP 13791849 A EP13791849 A EP 13791849A EP 2941186 A1 EP2941186 A1 EP 2941186A1
Authority
EP
European Patent Office
Prior art keywords
gas
tracking device
data
treatment
flow rate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP13791849.6A
Other languages
German (de)
French (fr)
Inventor
Thierry Boulanger
Mickaël Libardi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Air Liquide Medical Systems SA
Original Assignee
Air Liquide Medical Systems SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Air Liquide Medical Systems SA filed Critical Air Liquide Medical Systems SA
Publication of EP2941186A1 publication Critical patent/EP2941186A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/087—Measuring breath flow
    • A61B5/0878—Measuring breath flow using temperature sensing means
    • 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; 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
    • G01F1/68—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 thermal effects
    • G01F1/684—Structural arrangements; Mounting of elements, e.g. in relation to fluid flow
    • G01F1/688—Structural arrangements; Mounting of elements, e.g. in relation to fluid flow using a particular type of heating, cooling or sensing element
    • G01F1/6888—Thermoelectric elements, e.g. thermocouples, thermopiles
    • 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
    • G01F1/68—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 thermal effects
    • G01F1/684—Structural arrangements; Mounting of elements, e.g. in relation to fluid flow
    • G01F1/688—Structural arrangements; Mounting of elements, e.g. in relation to fluid flow using a particular type of heating, cooling or sensing element
    • G01F1/69—Structural arrangements; Mounting of elements, e.g. in relation to fluid flow using a particular type of heating, cooling or sensing element of resistive type
    • 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
    • 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. mouth-to-mouth respiration; 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. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
    • 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. mouth-to-mouth respiration; 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. mouth-to-mouth respiration; 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
    • A61M2016/0036—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the breathing tube and used in both inspiratory and expiratory phase
    • 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. mouth-to-mouth respiration; 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
    • A61M2205/15—Detection of leaks
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3358—Measuring barometric pressure, e.g. for compensation
    • 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
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A61M2205/3372—Temperature compensation
    • 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
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
    • 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
    • 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

  • Thermosensitive cell device for monitoring the observance of a medical treatment
  • the present invention relates to a device for monitoring the compliance of a therapeutic treatment with gas administration to a patient comprising a flow rate determining device comprising at least one heat-sensitive cell for determining the flow rate of the gas flowing in said gas passage.
  • the observance of the treatment ie whether the patient uses his ventilator properly in accordance with the prescriptions, and the effectiveness of the treatment, namely whether the patient is well fitted to its fan, that is to say in the absence of leaks, and well adapted to its fan, that is to say in the absence of events such as apnea, hypoventilation or other, are elements essential to the proper follow-up of a patient.
  • EP-A-2329768 and EP-A-2506766 propose a device whose measurement principle is based on the Venturi effect. This device integrates within it two absolute pressure sensors whose differential, associated with a particular geometry, gives an image of the flow through it. This device meets an essential requirement by presenting a low pressure drop, that is to say that it does not influence a priori on the performance of the fans on which it comes to be connected.
  • the device performs only one unidirectional measurement, that is to say the flow delivered by the machine to the patient, that is to say the inspired flow, and not the patient's flow towards the machine, that is to say the expired flow.
  • a reliable estimate of leaks which is an essential parameter of observance of the good patient / machine adequacy, can only be realized by having the notion of inspired and expired volumes.
  • this type of dedicated device allows only low measurement accuracy in low flow rates. Indeed, the measuring principle requires to accommodate low pressure losses.
  • this measurement relies on the exploitation of the signals of two independent pressure sensors. Therefore, the differential of the two measurements, making it possible to appreciate the pressure drop and therefore the flow flowing in the nozzle, is tainted with errors, ie intrinsic errors of each of the sensors (calibration, drifts ).
  • the disturbances from the fan generate in this range of flow, so low pressure range, a pneumatic noise such that the operation of the differential becomes very difficult.
  • thermocouple element intended to be inserted into the airways of the patient to measure the gas flow.
  • Such a device is not suitable for home use because of the need to insert the thermocouple element directly into the lungs of the patient and therefore the obligation to use medical personnel for the establishment.
  • the problem that arises is to propose an improved dedicated device for monitoring the observance of a treatment that does not have the above-mentioned drawbacks, which can be easily used by a patient at home, that is to say without resorting to to nursing staff.
  • the solution is a device for monitoring the adherence of a treatment with gas administration to an individual comprising:
  • thermosensitive cell comprising at least one heating element and at least two groups of thermocouples (or thermopiles in English),
  • thermocouple group and the second thermocouple group are adapted to and capable of providing voltage values U1, U2 representative of the temperatures T1, T2 of the gas on either side of the heating element, and for delivering at least one voltage difference signal, and
  • one or two absolute pressure sensors or a relative pressure sensor for determining at least one pressure difference between at least a portion of the passage and the external atmosphere
  • processing means receiving said at least one voltage difference signal from said first and second thermocouple groups and calculating at least one gas flow in the passage from said at least one voltage difference signal, said processing means being otherwise adapted to and designed to process said flow rate and pressure values, and derive at least one daily treatment time data and at least one treatment efficiency data
  • the device of the invention may comprise one or more of the following technical characteristics:
  • the heating element is arranged between a first thermocouple group and a second thermocouple group.
  • thermocouple group and the second thermocouple group are arranged to supply voltage values representative of the gas temperatures on either side of the heating element, and to deliver at least one voltage difference signal.
  • data storage means for storing at least one of said data.
  • transmission means adapted to and designed to transmit at least one of said data.
  • the processing means comprise at least one microcontroller.
  • the transmission means comprise a wireless transmitter system and an antenna making it possible to ensure wireless transmission of the data.
  • the data storage means comprise at least one memory chip or a memory card.
  • the radio frequency transmitter system includes a GSM or GPRS modem.
  • the GSM or GPRS modem sends the patient treatment compliance and efficiency data records to a server for generating compliance and treatment efficiency reports.
  • the passage of gas, said at least one pressure sensor, said flow rate determining device, said at least one heat-sensitive cell comprising at least one heating element and at least two groups of thermocouples, the one or both absolute pressure sensors or the relative pressure sensor, and the processing means are arranged within a common housing.
  • the processing means implement an algorithm able to perform a processing of the measured data and / or measurements made.
  • the invention also relates to a treatment plant or apparatus comprising a ventilation machine fluidly connected to the inlet of a tracking device according to the invention, so as to supply said monitoring device with gas under pressure.
  • FIG. 1 is a block diagram of an embodiment of a ventilation system equipped with an observance monitoring device according to the present invention
  • FIGS. 2a side view
  • 2b sectional view
  • FIG. 3 schematizes an embodiment of a thermosensitive cell of the flow rate determination device of FIG. 2 and
  • FIG. 4 schematizes a possible internal architecture of the device for monitoring compliance according to the present invention.
  • an installation or apparatus for treating a patient by administering pressurized gas, in particular for treating Obstructive Sleep Apnea comprising a ventilation machine 11, for example of the CPAP, APAP, BiPAP or analogous, fluidly connected to the inlet of an observance monitoring device 10 according to the invention, so as to supply said device with pressurized gas, typically air or air enriched with oxygen.
  • pressurized gas typically air or air enriched with oxygen.
  • the device 10 for monitoring the compliance of a treatment comprises a housing, for example a polymer material, coming to connect in the path of the breathing gas, typically pressurized air, that is, ie on the patient circuit 12 connecting the machine 11 to the respiratory mask 13, generally nasal, equipping the patient 14 to be treated.
  • a housing for example a polymer material
  • connection of the device 10 to the patient circuit 12 is made by means of flexible tubes with conventional tips, for example tips having a diameter of 22 mm and conforming to the ISO 5356-1 standard.
  • the compliance monitoring device 10 comprises a housing through which an internal passage 1 of gas fluidly connects an inlet 2 to an outlet 3 of gas in which passes the gas delivered by the fan 11, before being conveyed to the patient 14, via the flexible pipe 12 and the mask 13.
  • a flow rate determining device is arranged in the housing and is connected to the passage 1 so as to allow a measurement of the flow rate of the gas flowing inside said passage 1, that is to say between the inlet 2 and the exit 3.
  • thermosensitive cell 4 is used arranged in the gas path, as illustrated in FIGS. 2a and 2b, that is to say directly inserted in the gas flow.
  • thermosensitive commercial reference cell PTFD10 marketed by POSIFA.
  • such a heat-sensitive cell 4 comprises a support 8 carrying a heating element 5, for example an electric heating resistor, two thermocouple groups 6, 7, and a reference resistance 9 varying according to the ambient temperature, so that to constitute a kind of thermal mass.
  • a heating element 5 for example an electric heating resistor
  • thermocouple groups 6, 7, and a reference resistance 9 varying according to the ambient temperature, so that to constitute a kind of thermal mass.
  • the heating element 5 is arranged between a first thermocouple group 6 and a second thermocouple group 7 so as to be able to deliver voltage values U1, U2 representative of the temperatures T1, T2 of the gas on either side of the heating element 5 from which voltage values U1, U2 is calculated a voltage difference signal which can be used to determine, via processing means, the flow rate of the gas flowing in contact with said thermosensitive cell 4.
  • thermosensitive cell 4 uses the gradient or the temperature difference on either side of the heating element 5.
  • the gas coming into contact with the cell 4 while being at a first temperature T1 raises its temperature in contact with the heating element 4 which reaches a second temperature T2 with T2> T1.
  • This difference in temperature can be used to calculate the gas flow because the flow is then a function of the difference between the two temperatures T1 and T2.
  • thermosensitive cell 4 is advantageous because to measure the range of flows involved in this application, its implementation requires a passage diameter of between 15 and 20 mm, that is to say much greater than the diameter of passage of devices of the prior art.
  • This arrangement thus gives the tracking device 10 of the invention full compatibility with all the fans to which it is likely to be connected.
  • the device 10 according to the invention has the following advantages:
  • thermosensitive cell 4 is not sensitive to moisture.
  • the heating element of the cell (several hundreds of degrees) prevents any condensation on the sensitive part, that is to say that the access to the measurement is permanent and patient compliance is continuously achieved.
  • one or two absolute pressure sensors or a relative pressure sensor 26 which are / are also arranged on the passage 1 so as to make it possible to determine the pressure at the pressure. inside the passage 1 between said inlet 2 and outlet 3.
  • the flow rate determination device 4 and the pressure sensor (s) 26 are furthermore connected to processing means 21, such as an algorithm microcontroller (s), for example the Texas Instruments MSP430 microcontroller, capable of processing the pressure and flow measurements in order to deduce the daily treatment duration and the effectiveness of the treatment of patient P.
  • processing means 21 such as an algorithm microcontroller (s), for example the Texas Instruments MSP430 microcontroller, capable of processing the pressure and flow measurements in order to deduce the daily treatment duration and the effectiveness of the treatment of patient P.
  • the pressure sensor (s) 26 may be, for example, BMP085 sensors marketed by BOSCH which are high precision barometric digital pressure sensors (up to 0.03 hPa) and low energy consumption (up to 0.03 hPa). about 3 ⁇ ).
  • Data storage means 23 are used to store all or part of the data thus measured, for example a data storage memory chip or a plug-in memory card, in particular an 8 GB SST flash memory card.
  • transmission means 24, 25, such as a radio frequency transmitter 24 and its antenna 25, are provided to enable all or part of said data to be transmitted 16, preferably via a wireless transmission, to a remote receiver.
  • a remote receiver such as a computer 17 or a server 18, as illustrated in FIG. 1.
  • the radiofrequency transmitter 24 may for example be equipped with an 870 MHz antenna 25 of PHYCOMP.
  • Power supply means 22 provide the power supply of the device, for example a low voltage power supply comprising one or more batteries, batteries, etc.
  • the compliance monitoring device 10 has the function of measuring, independently of the processing machine 11, for example AOS, and without using information or data internal to this device 11, and remotely communicate, wirelessly, the information relating not only to the compliance but also to the effectiveness of a treatment, that is to say say the duration of effective treatment of patients, as well as respiratory events including apnea, hypopneas, flow limitations, snoring, leaks ...
  • the device 10 of the invention has a recording capacity of several months, preferably at least 1 year, which can be further extended.
  • USB wired data to a computer, PDA, server, or any other means that can directly record transmitted data, as shown in Figure 2.
  • the device transmits remotely using the integrated GSM or GPRS modem which sends the patient's treatment compliance and efficiency data records to the care center for example, where a suitable S server allows Generate compliance and treatment efficiency reports.
  • the device of the invention makes it possible to measure the duration of treatment of the patient and its effectiveness when it is treated.
  • the device 10 of the invention allows such compliance and therefore effective monitoring of patients through the processing of data measured by an algorithm independent of the processing machine.
  • the device 10 of the invention is used in the context of any method of therapeutic treatment, in particular obstructive sleep apnea syndrome (OSA) of a patient characterized in particular by an obstruction of his upper airways.
  • OSA obstructive sleep apnea syndrome

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

Abstract

The invention relates to a device for monitoring the observance of a treatment involving administration of gas to an individual, comprising a gas inlet (2) and a gas outlet (3), a gas passage (1) fluidically connecting the gas inlet (2) to the gas outlet (3), at least one pressure sensor, and a flow-rate determining device (4, 5, 6, 7), arranged in the gas passage (1), for determining the flow rate of the gas flowing through said gas passage (1). The flow-rate determining device (4, 5, 6, 7) comprises at least one heat-sensitive cell (4).

Description

Dispositif à cellule thermosensible de suivi de l'observance d'un traitement médical  Thermosensitive cell device for monitoring the observance of a medical treatment
La présente invention concerne un dispositif de suivi de l'observance d'un traitement thérapeutique avec administration de gaz à un patient comprenant un dispositif de détermination de débit comprenant au moins une cellule thermosensible pour déterminer le débit du gaz circulant dans ledit passage de gaz. The present invention relates to a device for monitoring the compliance of a therapeutic treatment with gas administration to a patient comprising a flow rate determining device comprising at least one heat-sensitive cell for determining the flow rate of the gas flowing in said gas passage.
Dans le cadre d'une observance de la ventilation des patients à domicile, il convient de retourner différentes informations au prescripteur témoignant de la bonne adéquation du patient à son ventilateur, en particulier lors du traitement de pathologies du type apnée du sommeil.  As part of an observance of ventilation of patients at home, it is appropriate to return various information to the prescriber testifying to the adequacy of the patient to his ventilator, especially during the treatment of pathologies like sleep apnea.
En particulier, l'observance du traitement, c'est-à-dire le fait de savoir si le patient utilise bien son ventilateur conformément aux prescriptions, et l'efficacité du traitement, à savoir le fait de savoir si le patient est bien appareillé à son ventilateur, c'est-à-dire en l'absence de fuites, et bien adapté à son ventilateur, c'est-à-dire en l'absence d'événements de type apnées, hypoventilation ou autres, sont des éléments essentiels du bon suivi d'un patient.  In particular, the observance of the treatment, ie whether the patient uses his ventilator properly in accordance with the prescriptions, and the effectiveness of the treatment, namely whether the patient is well fitted to its fan, that is to say in the absence of leaks, and well adapted to its fan, that is to say in the absence of events such as apnea, hypoventilation or other, are elements essential to the proper follow-up of a patient.
Pour restituer au prescripteur de telles informations, on peut :  To restore to the prescriber such information, one can:
- soit équiper le ventilateur d'un boîtier de télétransmission et procéder à une analyse des événements par le biais des capteurs (pression / débit) de l'appareil. Ceci suppose toutefois autant d'outils d'analyse qu'il existe de fabricants, ce qui n'est pas pratique.  - either equip the fan with a remote transmission unit and perform an event analysis via the sensors (pressure / flow) of the device. However, this assumes as many analysis tools as there are manufacturers, which is not practical.
- soit utiliser un dispositif dédié connecté en sortie de ventilateur pour mesurer les valeurs de pression et débit, pour analyser les événements et ensuite les télétransmettre au prescripteur par exemple. Ceci permet de centraliser les informations de n'importe quel ventilateur sur un support unique et est donc une manière de faire préférée.  - Or use a dedicated device connected to the fan outlet to measure the pressure and flow rate values, to analyze the events and then to send them to the prescriber, for example. This makes it possible to centralize the information of any fan on a single support and is therefore a preferred way of doing things.
Il a déjà été proposé des dispositifs dédiés connectables en sortie de ventilateur. Ainsi, les documents EP-A-2329768 et EP-A-2506766 proposent un dispositif dont le principe de mesure repose sur l'effet Venturi. Ce dispositif intègre en son sein deux capteurs de pression absolue dont le différentiel, associé à une géométrie particulière, donne une image du débit le traversant. Ce dispositif répond à une exigence essentielle en présentant une perte de charge faible, c'est-à-dire qu'il n'influe à priori pas sur les performances des ventilateurs sur lesquels il vient à être connecté.  It has already been proposed dedicated devices connectable fan output. Thus, EP-A-2329768 and EP-A-2506766 propose a device whose measurement principle is based on the Venturi effect. This device integrates within it two absolute pressure sensors whose differential, associated with a particular geometry, gives an image of the flow through it. This device meets an essential requirement by presenting a low pressure drop, that is to say that it does not influence a priori on the performance of the fans on which it comes to be connected.
Toutefois, ce type de dispositif dédié présente plusieurs inconvénients.  However, this type of dedicated device has several disadvantages.
Tout d'abord, le dispositif ne réalise qu'une mesure unidirectionnelle, c'est-à-dire du débit fourni par la machine vers le patient, c'est-à-dire le débit inspiré, et non du débit du patient vers la machine, c'est-à-dire du débit expiré. Or, une estimation fiable des fuites, qui est un paramètre d'observance essentiel de la bonne adéquation patient/machine, ne peut être réalisée qu'en ayant la notion des volumes inspirés et expirés. Firstly, the device performs only one unidirectional measurement, that is to say the flow delivered by the machine to the patient, that is to say the inspired flow, and not the patient's flow towards the machine, that is to say the expired flow. However, a reliable estimate of leaks, which is an essential parameter of observance of the good patient / machine adequacy, can only be realized by having the notion of inspired and expired volumes.
Ensuite, ce type de dispositif dédié ne permet qu'une faible précision de mesure dans les bas débits. En effet, le principe de mesure nécessite de s'accommoder de faibles pertes de charge. Or, cette mesure repose sur l'exploitation des signaux de deux capteurs de pression indépendants. Dès lors, le différentiel des deux mesures, permettant d'apprécier la perte de charge et donc le débit circulant dans la tuyère, est entaché d'erreurs, à savoir des erreurs intrinsèques de chacun des capteurs (étalonnage, dérives...). De plus, les perturbations issues du ventilateur engendrent dans cette gamme de débit, donc faible gamme de pression, un bruit pneumatique tel que l'exploitation du différentiel en devient très difficile.  Then, this type of dedicated device allows only low measurement accuracy in low flow rates. Indeed, the measuring principle requires to accommodate low pressure losses. However, this measurement relies on the exploitation of the signals of two independent pressure sensors. Therefore, the differential of the two measurements, making it possible to appreciate the pressure drop and therefore the flow flowing in the nozzle, is tainted with errors, ie intrinsic errors of each of the sensors (calibration, drifts ...). In addition, the disturbances from the fan generate in this range of flow, so low pressure range, a pneumatic noise such that the operation of the differential becomes very difficult.
Par ailleurs, en cas de nécessité de mettre en œuvre une humidification du gaz envoyé vers les voies aériennes du patient, ce qui est le cas dans environ 50% des prescriptions, la condensation d'eau qui se forme dans le dispositif est de nature à altérer la mesure de débit. Le dispositif reconnaît alors cette condition et stoppe l'analyse de la ventilation patient et il s'ensuit alors une perte d'observance préjudiciable.  Moreover, if it is necessary to implement humidification of the gas sent to the airways of the patient, which is the case in about 50% of prescriptions, the condensation of water that forms in the device is likely to alter the flow measurement. The device then recognizes this condition and stops the analysis of the patient ventilation and it then follows a loss of observance detrimental.
Par ailleurs, on connaît le document US-A-2011/0201956 qui décrit un appareil de mesure des flux pulmonaires comprenant un élément à thermocouple destiné à venir s'insérer dans les voies aériennes du patient pour y mesurer le flux gazeux. Un tel appareil n'est pas adapté à une utilisation à domicile du fait de la nécessité d'insérer l'élément à thermocouple directement dans les poumons du patient et donc de l'obligation de recourir à du personnel médical pour la mise en place.  Furthermore, US-A-2011/0201956 discloses a pulmonary flow measuring apparatus comprising a thermocouple element intended to be inserted into the airways of the patient to measure the gas flow. Such a device is not suitable for home use because of the need to insert the thermocouple element directly into the lungs of the patient and therefore the obligation to use medical personnel for the establishment.
Le problème qui se pose est de proposer un dispositif dédié amélioré de suivi de l'observance d'un traitement ne présentant pas les inconvénients susmentionnés, qui soit aisément utilisable par un patient à son domicile, c'est-à-dire sans avoir recours à du personnel soignant.  The problem that arises is to propose an improved dedicated device for monitoring the observance of a treatment that does not have the above-mentioned drawbacks, which can be easily used by a patient at home, that is to say without resorting to to nursing staff.
La solution est un dispositif de suivi de l'observance d'un traitement avec administration de gaz à un individu comprenant :  The solution is a device for monitoring the adherence of a treatment with gas administration to an individual comprising:
- une entrée de gaz et une sortie de gaz, et un passage de gaz joignant f uidiquement l'entrée de gaz à la sortie de gaz,  a gas inlet and a gas outlet, and a gas passage joining the gas inlet to the gas outlet;
- au moins un capteur de pression, et  at least one pressure sensor, and
- un dispositif de détermination de débit, agencé dans le passage de gaz, pour déterminer le débit du gaz circulant dans ledit passage de gaz, ledit dispositif de détermination de débit comprenant au moins une cellule thermosensible comprenant au moins un élément chauffant et au moins deux groupes de thermocouples (ou thermopiles en anglais),  a flow-rate determination device, arranged in the gas passage, for determining the flow rate of the gas flowing in said gas passage, said flow-rate determining device comprising at least one thermosensitive cell comprising at least one heating element and at least two groups of thermocouples (or thermopiles in English),
caractérisé en ce que le premier groupe thermocouple et le second groupe thermocouple sont conçus pour et aptes à fournir des valeurs de tension Ul, U2 représentatives des températures Tl, T2 du gaz de part et d'autre de l'élément chauffant, et pour délivrer au moins un signal de différence de tension, et characterized in that the first thermocouple group and the second thermocouple group are adapted to and capable of providing voltage values U1, U2 representative of the temperatures T1, T2 of the gas on either side of the heating element, and for delivering at least one voltage difference signal, and
et en ce qu'il comprend en outre :  and further comprising:
- un ou deux capteurs de pression absolue ou un capteur de pression relative pour déterminer au moins une différence de pression entre au moins une partie du passage et l'atmosphère extérieure, et  one or two absolute pressure sensors or a relative pressure sensor for determining at least one pressure difference between at least a portion of the passage and the external atmosphere, and
- des moyens de traitement recevant ledit au moins un signal de différence de tension provenant desdits premier et second groupes thermocouples et calculant au moins un débit de gaz dans le passage à partir dudit au moins un signal de différence de tension, lesdits moyens de traitement étant par ailleurs aptes à et conçus pour traiter lesdites valeurs de débit et de pression, et en déduire au moins une donnée de durée de traitement journalier et au moins une donnée d'efficacité de traitement  processing means receiving said at least one voltage difference signal from said first and second thermocouple groups and calculating at least one gas flow in the passage from said at least one voltage difference signal, said processing means being otherwise adapted to and designed to process said flow rate and pressure values, and derive at least one daily treatment time data and at least one treatment efficiency data
Selon le cas, le dispositif de l'invention peut comprendre l'une ou plusieurs des caractéristiques techniques suivantes :  As the case may be, the device of the invention may comprise one or more of the following technical characteristics:
- l'élément chauffant est agencé entre un premier groupe thermocouple et un second groupe thermocouple.  the heating element is arranged between a first thermocouple group and a second thermocouple group.
- le premier groupe thermocouple et le second groupe thermocouple sont agencés de manière à fournir des valeurs de tension représentatives des températures du gaz de part et d'autre de l'élément chauffant, et pour délivrer au moins un signal de différence de tension.  the first thermocouple group and the second thermocouple group are arranged to supply voltage values representative of the gas temperatures on either side of the heating element, and to deliver at least one voltage difference signal.
- il comprend des moyens de stockage de données pour mémoriser au moins l'une desdites données.  it comprises data storage means for storing at least one of said data.
- il comprend des moyens d'émission aptes à et conçus pour transmettre au moins l'une desdites données.  it comprises transmission means adapted to and designed to transmit at least one of said data.
- les moyens de traitement comprennent au moins un microcontrôleur.  the processing means comprise at least one microcontroller.
- les moyens d'émission comprennent un système émetteur sans fil et une antenne permettant d'assurer une transmission sans fil des données.  the transmission means comprise a wireless transmitter system and an antenna making it possible to ensure wireless transmission of the data.
- les moyens de stockage de données comprennent au moins une puce mémoire ou une carte mémoire.  the data storage means comprise at least one memory chip or a memory card.
- le système émetteur radio fréquence comprend un modem GSM ou GPRS.  - The radio frequency transmitter system includes a GSM or GPRS modem.
- le modem GSM ou GPRS envoie les enregistrements des données d'observance et d'efficacité du traitement du patient à un serveur permettant de générer des rapports d'observance et d'efficacité de traitement.  the GSM or GPRS modem sends the patient treatment compliance and efficiency data records to a server for generating compliance and treatment efficiency reports.
- il comprend en outre des moyens d'alimentation en courant électrique, typiquement une alimentation électrique à tension inférieure à 50V.  - It further comprises power supply means, typically a power supply voltage less than 50V.
- il comprend en outre un ou des indicateurs fournissant à l'utilisateur une information relative à l'efficacité du traitement appliqué au moyen du dispositif. - le passage de gaz, ledit au moins un capteur de pression, ledit dispositif de détermination de débit, ladite au moins une cellule thermosensible comprenant au moins un élément chauffant et au moins deux groupes de thermocouples, le ou les deux capteurs de pression absolue ou le capteur de pression relative, et les moyens de traitement sont agencés au sein d'un boîtier commun. - It further comprises one or more indicators providing the user with information relating to the effectiveness of the treatment applied by means of the device. the passage of gas, said at least one pressure sensor, said flow rate determining device, said at least one heat-sensitive cell comprising at least one heating element and at least two groups of thermocouples, the one or both absolute pressure sensors or the relative pressure sensor, and the processing means are arranged within a common housing.
- les moyens de traitement mettent en œuvre un algorithme apte à opérer un traitement des données mesurées et/ou des mesures réalisées.  the processing means implement an algorithm able to perform a processing of the measured data and / or measurements made.
L'invention concerne aussi une installation ou un appareillage de traitement comprenant une machine de ventilation reliée fluidiquement à l'entrée d'un dispositif de suivi selon l'invention, de manière à alimenter ledit dispositif de suivi en gaz sous pression. The invention also relates to a treatment plant or apparatus comprising a ventilation machine fluidly connected to the inlet of a tracking device according to the invention, so as to supply said monitoring device with gas under pressure.
L'invention va être mieux comprise grâce à la description suivante, faite en références aux Figures annexées parmi lesquelles :  The invention will be better understood thanks to the following description, given with reference to the appended figures among which:
- la Figure 1 est un schéma de principe d'un mode de réalisation d'une installation de ventilation équipé d'un dispositif de suivi de l'observance selon la présente invention ;  - Figure 1 is a block diagram of an embodiment of a ventilation system equipped with an observance monitoring device according to the present invention;
- les Figures 2a (vue de côté) et 2b (vue en section) représentent le dispositif de détermination de débit équipant le dispositif de suivi de l'observance la Figure 1,  FIGS. 2a (side view) and 2b (sectional view) show the flow rate determining device fitted to the device for monitoring the observance of FIG. 1,
- la Figure 3 schématise un mode de réalisation d'une cellule thermosensible du dispositif de détermination de débit de la Figure 2 et  FIG. 3 schematizes an embodiment of a thermosensitive cell of the flow rate determination device of FIG. 2 and
- la Figure 4 schématise une architecture interne possible du dispositif de suivi de l'observance selon la présente invention.  FIG. 4 schematizes a possible internal architecture of the device for monitoring compliance according to the present invention.
Comme illustré en Figure 1, une installation ou appareillage de traitement d'un patient par administration de gaz sous pression, notamment de traitement de l'Apnée Obstructive du Sommeil, comprenant une machine de ventilation 11 par exemple de type CPAP, APAP, BiPAP ou analogue, reliée fluidiquement à l'entrée d'un dispositif de suivi de l'observance 10 selon l'invention, de manière à alimenter ledit dispositif en gaz sous pression, typiquement en air ou en air enrichi en oxygène.  As illustrated in FIG. 1, an installation or apparatus for treating a patient by administering pressurized gas, in particular for treating Obstructive Sleep Apnea, comprising a ventilation machine 11, for example of the CPAP, APAP, BiPAP or analogous, fluidly connected to the inlet of an observance monitoring device 10 according to the invention, so as to supply said device with pressurized gas, typically air or air enriched with oxygen.
Le dispositif 10 de suivi de l'observance d'un traitement selon la présente invention comprend un boîtier, par exemple en un matériau polymère, venant se raccorder sur le trajet du gaz respiratoire, typiquement de l'air sous pression, c'est-à-dire sur le circuit patient 12 reliant la machine 11 au masque 13 respiratoire, en général nasal, équipant le patient 14 à traiter.  The device 10 for monitoring the compliance of a treatment according to the present invention comprises a housing, for example a polymer material, coming to connect in the path of the breathing gas, typically pressurized air, that is, ie on the patient circuit 12 connecting the machine 11 to the respiratory mask 13, generally nasal, equipping the patient 14 to be treated.
La connexion du dispositif 10 au circuit patient 12 se fait au moyen de tubes flexibles à embouts classiques, par exemple des embouts de diamètre égal à 22 mm et conformes à la norme ISO 5356-1.  The connection of the device 10 to the patient circuit 12 is made by means of flexible tubes with conventional tips, for example tips having a diameter of 22 mm and conforming to the ISO 5356-1 standard.
Plus précisément, le dispositif de suivi de l'observance 10 comprend un boîtier traversé par un passage 1 interne de gaz reliant fluidiquement une entrée 2 à une sortie 3 de gaz au sein duquel transite le gaz débité par le ventilateur 11, avant d'être acheminé jusqu'à au patient 14, via la conduite souple 12 et le masque 13. More specifically, the compliance monitoring device 10 comprises a housing through which an internal passage 1 of gas fluidly connects an inlet 2 to an outlet 3 of gas in which passes the gas delivered by the fan 11, before being conveyed to the patient 14, via the flexible pipe 12 and the mask 13.
Un dispositif de détermination de débit est agencé dans le boîtier et est relié au passage 1 de manière à permettre une mesure du débit du gaz circulant à l'intérieur dudit passage 1, c'est-à-dire entre l'entrée 2 et la sortie 3.  A flow rate determining device is arranged in the housing and is connected to the passage 1 so as to allow a measurement of the flow rate of the gas flowing inside said passage 1, that is to say between the inlet 2 and the exit 3.
Selon l'invention, en tant que dispositif de détermination de débit, on utilise une cellule thermosensible 4 agencée sur le trajet du gaz, comme illustré en Figures 2a et 2b, c'est-à-dire directement insérée dans le flux gazeux.  According to the invention, as a flow rate determining device, a thermosensitive cell 4 is used arranged in the gas path, as illustrated in FIGS. 2a and 2b, that is to say directly inserted in the gas flow.
Par exemple, on peut utiliser une cellule thermosensible de référence commerciale PTFD10 commercialisée par la société POSIFA.  For example, it is possible to use a thermosensitive commercial reference cell PTFD10 marketed by POSIFA.
Comme illustré en Figure 3, une telle cellule thermosensible 4 comprend un support 8 portant un élément chauffant 5, par exemple une résistance électrique chauffante, deux groupes thermocouples 6, 7, et une résistance 9 de référence variant en fonction de la température ambiante de sorte de constituer une sorte de masse thermique.  As illustrated in FIG. 3, such a heat-sensitive cell 4 comprises a support 8 carrying a heating element 5, for example an electric heating resistor, two thermocouple groups 6, 7, and a reference resistance 9 varying according to the ambient temperature, so that to constitute a kind of thermal mass.
L'élément chauffant 5 est agencé entre un premier groupe thermocouple 6 et un second groupe thermocouple 7 de manière à pouvoir délivrer des valeurs de tension Ul , U2 représentatives des températures Tl, T2 du gaz de part et d'autre de l'élément chauffant 5 à partir desquelles valeurs de tension Ul, U2, est calculé un signal de différence de tension qui peut être utilisé pour déterminer, via des moyens de traitement, le débit du gaz circulant au contact de ladite cellule thermosensible 4.  The heating element 5 is arranged between a first thermocouple group 6 and a second thermocouple group 7 so as to be able to deliver voltage values U1, U2 representative of the temperatures T1, T2 of the gas on either side of the heating element 5 from which voltage values U1, U2 is calculated a voltage difference signal which can be used to determine, via processing means, the flow rate of the gas flowing in contact with said thermosensitive cell 4.
En d'autres termes, la cellule thermosensible 4 exploite le gradient ou la différence de température de part et d'autre de l'élément chauffant 5. Le gaz arrivant au contact de la cellule 4 en étant à une première température Tl (mesurée) élève sa température au contact de l'élément chauffant 4 laquelle atteint une seconde température T2 avec T2>T1. Cette différence de température peut être utilisée pour calculer le débit du gaz car le débit est alors une fonction de la différence entre les deux températures Tl et T2.  In other words, the thermosensitive cell 4 uses the gradient or the temperature difference on either side of the heating element 5. The gas coming into contact with the cell 4 while being at a first temperature T1 (measured) raises its temperature in contact with the heating element 4 which reaches a second temperature T2 with T2> T1. This difference in temperature can be used to calculate the gas flow because the flow is then a function of the difference between the two temperatures T1 and T2.
Mettre en œuvre une cellule thermosensible 4 est avantageux car pour mesurer la gamme de débits en jeu dans cette application, sa mise en œuvre requiert un diamètre de passage compris entre 15 et 20 mm, c'est-à-dire bien supérieur au diamètre de passage des dispositifs de l'art antérieur.  Implementing a thermosensitive cell 4 is advantageous because to measure the range of flows involved in this application, its implementation requires a passage diameter of between 15 and 20 mm, that is to say much greater than the diameter of passage of devices of the prior art.
Cette disposition confère ainsi au dispositif de suivi 10 de l'invention une entière compatibilité avec tous les ventilateurs auxquels il est susceptible d'être connecté.  This arrangement thus gives the tracking device 10 of the invention full compatibility with all the fans to which it is likely to be connected.
En outre, le dispositif 10 selon l'invention présente les avantages suivants :  In addition, the device 10 according to the invention has the following advantages:
- une bidirectionnalité des mesures. Le système reposant sur un différentiel de température, il est alors possible de mesurer des gradients de température positifs et négatifs, c'est-à-dire de mesurer les débits inspirés et expirés par le patient. Cette caractéristique permet au dispositif de mesurer de manière fiable les fuites et d'en nourrir le rapport d'observance. - bonne précision de mesure y compris dans les bas débits. La mesure réalisée est une mesure purement différentielle d'éléments situés sur le même substrat et non la différence de deux mesures indépendantes, ce qui permet de maîtriser l'incertitude sur la mesure. De plus, plus le débit est faible, plus la vitesse du fluide est lente, c'est-à-dire que le gaz se réchauffe d'autant plus au contact de l'élément chauffant, augmentant alors le gradient de température. Autrement dit, plus le débit est faible, meilleure est la sensibilité de l'élément de mesure. - a bidirectionality of the measures. Since the system is based on a temperature differential, it is then possible to measure positive and negative temperature gradients, that is to say, to measure the flows inspired and exhaled by the patient. This feature allows the device to reliably measure leaks and feed the compliance ratio. - good measurement accuracy even in low flow rates. The measurement made is a purely differential measurement of elements located on the same substrate and not the difference of two independent measurements, which makes it possible to control the uncertainty on the measurement. In addition, the lower the flow rate, the slower the fluid velocity, that is to say that the gas heats the more in contact with the heating element, thus increasing the temperature gradient. In other words, the lower the flow rate, the better the sensitivity of the measuring element.
- disponibilité des mesures. La cellule thermosensible 4 n'est pas sensible à l'humidité. De plus, l'élément chauffant de la cellule (plusieurs centaines de degrés) empêche toute condensation sur la partie sensible, c'est-à-dire que l'accès à la mesure est permanent et l'observance du patient continûment réalisée.  - availability of measurements. The thermosensitive cell 4 is not sensitive to moisture. In addition, the heating element of the cell (several hundreds of degrees) prevents any condensation on the sensitive part, that is to say that the access to the measurement is permanent and patient compliance is continuously achieved.
Par ailleurs, comme montré en Figure 4, sont également prévus un ou deux capteurs de pression absolue ou un capteur de pression relative 26, lequel/lesquels est/sont également agencés sur le passage 1 de manière à permettre une détermination la pression à l'intérieur du passage 1 entre lesdites entrée 2 et sortie 3.  Furthermore, as shown in FIG. 4, there are also provided one or two absolute pressure sensors or a relative pressure sensor 26, which are / are also arranged on the passage 1 so as to make it possible to determine the pressure at the pressure. inside the passage 1 between said inlet 2 and outlet 3.
Le dispositif de détermination de débit 4 et le ou les capteurs de pression 26 sont connectés par ailleurs à des moyens de traitement 21, tel qu'un microcontrôleur à algorithme(s), par exemple le microcontrôleur MSP430 de Texas Instruments, capable de traiter les mesures de pression et de débit afin d'en déduire la durée de traitement journalier et l'efficacité du traitement du patient P.  The flow rate determination device 4 and the pressure sensor (s) 26 are furthermore connected to processing means 21, such as an algorithm microcontroller (s), for example the Texas Instruments MSP430 microcontroller, capable of processing the pressure and flow measurements in order to deduce the daily treatment duration and the effectiveness of the treatment of patient P.
Par ailleurs, le ou les capteurs de pression 26 peuvent être par exemple des capteurs BMP085 commercialisés par la société BOSCH qui sont des capteurs de pression digitaux barométriques à haute précision (jusqu'à 0,03 hPa) et faible consommation en énergie (jusqu'à environ 3 μΑ).  Furthermore, the pressure sensor (s) 26 may be, for example, BMP085 sensors marketed by BOSCH which are high precision barometric digital pressure sensors (up to 0.03 hPa) and low energy consumption (up to 0.03 hPa). about 3 μΑ).
Des moyens de stockage de données 23 sont utilisés pour mémoriser tout ou partie des données ainsi mesurées, par exemple une puce mémoire d'enregistrement de données ou une carte mémoire enfichable, notamment une carte mémoire flash de 8 Go de SST.  Data storage means 23 are used to store all or part of the data thus measured, for example a data storage memory chip or a plug-in memory card, in particular an 8 GB SST flash memory card.
Par ailleurs, des moyens d'émission 24, 25, tel un émetteur radio fréquence 24 et son antenne 25, sont prévus pour permettre de transmettre 16, de préférence via une transmission sans fil, tout ou partie desdites données vers un récepteur situé à distance, tel un ordinateur 17 ou un serveur 18, comme illustré sur la Figure 1. L'émetteur radiofréquence 24 peut par exemple être équipé d'une antenne 25 de 870 MHz de PHYCOMP.  Furthermore, transmission means 24, 25, such as a radio frequency transmitter 24 and its antenna 25, are provided to enable all or part of said data to be transmitted 16, preferably via a wireless transmission, to a remote receiver. , such as a computer 17 or a server 18, as illustrated in FIG. 1. The radiofrequency transmitter 24 may for example be equipped with an 870 MHz antenna 25 of PHYCOMP.
Des moyens d'alimentation en courant électrique 22 assurent l'alimentation électrique du dispositif, par exemple une alimentation électrique à basse tension comprenant une ou plusieurs batteries, piles...  Power supply means 22 provide the power supply of the device, for example a low voltage power supply comprising one or more batteries, batteries, etc.
Le dispositif de suivi de l'observance 10 selon la présente invention a pour fonction de mesurer, indépendamment de la machine 11 de traitement, par exemple de l'AOS, et donc sans utiliser d'information ou de donnée interne à cet appareil 11, et de communiquer à distance, sans fil, les informations relatives non seulement à l'observance mais également à l'efficacité d'un traitement, c'est-à-dire la durée de traitement effective des patients, ainsi que les événements respiratoires notamment les apnées, hypopnées, limitations de débit, ronflements, fuites... The compliance monitoring device 10 according to the present invention has the function of measuring, independently of the processing machine 11, for example AOS, and without using information or data internal to this device 11, and remotely communicate, wirelessly, the information relating not only to the compliance but also to the effectiveness of a treatment, that is to say say the duration of effective treatment of patients, as well as respiratory events including apnea, hypopneas, flow limitations, snoring, leaks ...
Ceci permet d'obtenir un suivi quotidien et une sécurité dans le suivi du traitement du patient à domicile grâce à la possibilité d'alarmer le patient et son centre de soins en cas de non suivi de la prescription ou de non efficacité du traitement.  This makes it possible to obtain a daily follow-up and a security in the follow-up of the treatment of the patient at home thanks to the possibility of alarming the patient and his center of care in the event of non-monitoring of the prescription or non effectiveness of the treatment.
Le dispositif 10 de l'invention possède une capacité d'enregistrement de plusieurs mois, de préférence d'au moins 1 an, laquelle peut être encore étendue.  The device 10 of the invention has a recording capacity of several months, preferably at least 1 year, which can be further extended.
Il peut communiquer les données enregistrées par liaison filaire USB vers un ordinateur, un PDA, un serveur ou tout autre moyen capable d'enregistrer directement les données transmises, comme montré en Figure 2.  It can communicate USB wired data to a computer, PDA, server, or any other means that can directly record transmitted data, as shown in Figure 2.
En fait, le dispositif transmet à distance à l'aide du modem GSM ou GPRS intégré qui envoie les enregistrements de données d'observance et d'efficacité du traitement du patient jusqu'au centre de soins par exemple, où un serveur S adapté permet de générer des rapports d'observance et d'efficacité de traitement.  In fact, the device transmits remotely using the integrated GSM or GPRS modem which sends the patient's treatment compliance and efficiency data records to the care center for example, where a suitable S server allows Generate compliance and treatment efficiency reports.
Comme déjà dit, le dispositif de l'invention permet de mesurer la durée de traitement du patient et son efficacité lorsqu'il se traite.  As already said, the device of the invention makes it possible to measure the duration of treatment of the patient and its effectiveness when it is treated.
Le dispositif 10 de l'invention permet une telle observance et donc un suivi efficace des patients grâce au traitement des données mesurées par un algorithme indépendant de la machine de traitement.  The device 10 of the invention allows such compliance and therefore effective monitoring of patients through the processing of data measured by an algorithm independent of the processing machine.
La délivrance automatique des résultats d'observance et d'efficacité du traitement est opérée quotidiennement et sans déplacement d'un intervenant puisque tout se fait à distance. Ensuite, l'interprétation des rapports est aisée et ce, quelle que soit la machine de traitement utilisée.  The automatic delivery of the results of observance and effectiveness of the treatment is carried out daily and without moving of a speaker since everything is done at a distance. Then, the interpretation of the reports is easy and this, whatever the processing machine used.
Le dispositif 10 de l'invention est utilisable dans le cadre de toute méthode de traitement thérapeutique, en particulier du syndrome d'apnée obstructive du sommeil (SAOS) d'un patient se caractérisant notamment par une obstruction de ses voies aériennes supérieures.  The device 10 of the invention is used in the context of any method of therapeutic treatment, in particular obstructive sleep apnea syndrome (OSA) of a patient characterized in particular by an obstruction of his upper airways.

Claims

Revendications claims
1. Dispositif de suivi de l'observance d'un traitement avec administration de gaz à un individu comprenant : A device for monitoring the adherence of a treatment with gas administration to an individual comprising:
- une entrée de gaz (2) et une sortie de gaz (3), et un passage de gaz (1) joignant fluidiquement l'entrée de gaz (2) à la sortie de gaz (3),  a gas inlet (2) and a gas outlet (3), and a gas passage (1) fluidly joining the gas inlet (2) to the gas outlet (3),
au moins un capteur de pression, et  at least one pressure sensor, and
- un dispositif de détermination de débit (4, 5, 6, 7) agencé dans le passage de gaz (1) pour déterminer le débit du gaz circulant dans ledit passage de gaz (1), ledit dispositif de détermination de débit (4, 5, 6, 7) comprenant au moins une cellule thermosensible (4) comprenant au moins un élément chauffant (5) et au moins deux groupes de thermocouples (6, 7),  a flow rate determining device (4, 5, 6, 7) arranged in the gas passage (1) for determining the flow rate of the gas flowing in said gas passage (1), said flow rate determining device (4, 5, 6, 7) comprising at least one thermosensitive cell (4) comprising at least one heating element (5) and at least two groups of thermocouples (6, 7),
caractérisé en ce que le premier groupe thermocouple (6) et le second groupe thermocouple (7) sont conçus pour et aptes à fournir des valeurs de tension (Ul, U2) représentatives des températures (Tl, T2) du gaz de part et d'autre de l'élément chauffant (5), et pour délivrer au moins un signal de différence de tension,  characterized in that the first thermocouple group (6) and the second thermocouple group (7) are designed for and capable of supplying voltage values (U1, U2) representative of the gas (Tl, T2) other of the heating element (5), and for delivering at least one voltage difference signal,
et en ce qu'il comprend en outre :  and further comprising:
- un ou deux capteurs de pression absolue ou un capteur de pression relative (26) pour déterminer au moins une différence de pression entre au moins une partie du passage (1) et l'atmosphère extérieure, et  one or two absolute pressure sensors or a relative pressure sensor (26) for determining at least one pressure difference between at least a portion of the passage (1) and the external atmosphere, and
- des moyens de traitement (21) recevant ledit au moins un signal de différence de tension provenant desdits premier et second groupes thermocouples (6, 7) et calculant au moins un débit de gaz dans le passage (1) à partir dudit au moins un signal de différence de tension, lesdits moyens de traitement (21) étant par ailleurs aptes à et conçus pour traiter lesdites valeurs de débit et de pression, et en déduire au moins une donnée de durée de traitement journalier et au moins une donnée d'efficacité de traitement.  processing means (21) receiving said at least one voltage difference signal from said first and second thermocouple groups (6, 7) and calculating at least one gas flow in the passage (1) from said at least one voltage difference signal, said processing means (21) being furthermore adapted to and designed to process said flow rate and pressure values, and to derive at least one data of daily processing time and at least one efficiency data. treatment.
2. Dispositif de suivi selon la revendication précédente, caractérisé en ce que l'élément chauffant (5) est agencé entre un premier groupe thermocouple (6) et un second groupe thermocouple (7). 2. Tracking device according to the preceding claim, characterized in that the heating element (5) is arranged between a first thermocouple group (6) and a second thermocouple group (7).
3. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce que les moyens de traitement (21) comprennent au moins un microcontrôleur. 3. Tracking device according to one of the preceding claims, characterized in that the processing means (21) comprise at least one microcontroller.
4. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce qu'il comprend en outre des moyens d'émission (24, 25) aptes à et conçus pour transmettre au moins l'une desdites données. 4. Tracking device according to one of the preceding claims, characterized in that it further comprises transmitting means (24, 25) adapted to and designed to transmit at least one of said data.
5. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce que les moyens d'émission (24, 25) sont aptes à et conçus pour transmettre les données d'observance et d'efficacité du traitement du patient à un ordinateur (17) ou à un serveur (18) distant permettant de générer des rapports d'observance et d'efficacité de traitement. 5. Tracking device according to one of the preceding claims, characterized in that the transmitting means (24, 25) are adapted to and designed to transmit the data of compliance and effectiveness of the treatment of the patient to a computer (17) or a remote server (18) for generating compliance and processing efficiency reports.
6. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce que les moyens d'émission (24, 25) comprennent un système émetteur sans fil et une antenne permettant d'assurer une transmission sans fil des données. 6. Tracking device according to one of the preceding claims, characterized in that the transmitting means (24, 25) comprises a wireless transmitter system and an antenna for ensuring a wireless transmission of data.
7. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce que le système émetteur sans fil est de type radiofréquence et comprend un modem GSM ou GPRS. 7. Tracking device according to one of the preceding claims, characterized in that the wireless transmitter system is radio frequency type and comprises a GSM or GPRS modem.
8. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce qu'il comprend en outre des moyens de stockage de données (23) pour mémoriser au moins l'une desdites données. 8. Tracking device according to one of the preceding claims, characterized in that it further comprises data storage means (23) for storing at least one of said data.
9. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce que les moyens de stockage de données (23) comprennent au moins une puce mémoire ou une carte mémoire. 9. Tracking device according to one of the preceding claims, characterized in that the data storage means (23) comprise at least one memory chip or a memory card.
10. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce que les moyens de traitement (21) mettent en œuvre un algorithme apte à opérer un traitement des données mesurées et/ou des mesures réalisées. 10. Tracking device according to one of the preceding claims, characterized in that the processing means (21) implement an algorithm capable of processing the measured data and / or measurements.
11. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce qu'il comprend en outre des moyens d'alimentation en courant électrique. 11. Tracking device according to one of the preceding claims, characterized in that it further comprises power supply means.
12. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce que le passage de gaz (1), ledit au moins un capteur de pression, ledit dispositif de détermination de débit (4, 5, 6, 7), ladite au moins une cellule thermosensible (4) comprenant au moins un élément chauffant (5) et au moins deux groupes de thermocouples (6, 7), le ou les deux capteurs de pression absolue ou le capteur de pression relative (26) et les moyens de traitement (21) sont agencés au sein d'un boîtier commun. 12. Tracking device according to one of the preceding claims, characterized in that the gas passage (1), said at least one pressure sensor, said flow rate determination device (4, 5, 6, 7), said at least one thermosensitive cell (4) comprising at least one heating element (5) and at least two groups of thermocouples (6, 7), the one or both absolute pressure sensors or the relative pressure sensor (26) and the means processing (21) are arranged within a common housing.
13. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce qu'il comprend en outre un ou des indicateurs fournissant à l'utilisateur une information relative à l'efficacité du traitement appliqué au moyen du dispositif. 13. Tracking device according to one of the preceding claims, characterized in that it further comprises one or more indicators providing the user with information relating to the effectiveness of the treatment applied by means of the device.
14. Dispositif de suivi selon l'une des revendications précédentes, caractérisé en ce que le ou les indicateurs fournissant à l'utilisateur une information relative à l'efficacité du traitement sont portés par le boîtier. 14. Monitoring device according to one of the preceding claims, characterized in that the indicator or indicators providing the user with information relating to the effectiveness of the treatment are carried by the housing.
15. Installation de traitement médical comprenant une machine de ventilation (11) reliée fluidiquement à l'entrée (2) d'un dispositif de suivi (10) selon l'une des revendications précédentes, de manière à alimenter ledit dispositif de suivi (10) en gaz sous pression. 15. A medical treatment installation comprising a ventilation machine (11) fluidly connected to the inlet (2) of a tracking device (10) according to one of the preceding claims, so as to feed said tracking device (10). ) in pressurized gas.
EP13791849.6A 2013-01-04 2013-10-21 Device having a heat-sensitive cell for monitoring the observance of a medical treatment Withdrawn EP2941186A1 (en)

Applications Claiming Priority (2)

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FR1350039A FR3000677A1 (en) 2013-01-04 2013-01-04 THERMOSENSITIVE CELL DEVICE FOR MONITORING THE OBSERVANCE OF MEDICAL TREATMENT
PCT/FR2013/052506 WO2014106696A1 (en) 2013-01-04 2013-10-21 Device having a heat-sensitive cell for monitoring the observance of a medical treatment

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US11986592B2 (en) 2021-05-14 2024-05-21 Dynasthetics, Llc Electronic firebreak systems and methods for use with oxygen delivery device

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