WO2014114875A1 - Device for monitoring the observance of a home oxygen therapy treatment - Google Patents

Device for monitoring the observance of a home oxygen therapy treatment Download PDF

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Publication number
WO2014114875A1
WO2014114875A1 PCT/FR2014/050115 FR2014050115W WO2014114875A1 WO 2014114875 A1 WO2014114875 A1 WO 2014114875A1 FR 2014050115 W FR2014050115 W FR 2014050115W WO 2014114875 A1 WO2014114875 A1 WO 2014114875A1
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WIPO (PCT)
Prior art keywords
data
data transmission
raw
transmission system
measurement
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PCT/FR2014/050115
Other languages
French (fr)
Inventor
Angelo AUGUSTO
Philippe Bernard
Amélie CARRON
Géraldine THIEBAUT
Claude Weber
Original Assignee
L'air Liquide, Societe Anonyme Pour L'etude Et L'exploitation Des Procedes Georges Claude
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 L'air Liquide, Societe Anonyme Pour L'etude Et L'exploitation Des Procedes Georges Claude filed Critical L'air Liquide, Societe Anonyme Pour L'etude Et L'exploitation Des Procedes Georges Claude
Priority to CN201480017473.0A priority Critical patent/CN105050645A/en
Priority to AU2014208996A priority patent/AU2014208996A1/en
Priority to EP14704844.1A priority patent/EP2950863A1/en
Priority to CA2898867A priority patent/CA2898867A1/en
Publication of WO2014114875A1 publication Critical patent/WO2014114875A1/en

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Classifications

    • 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
    • 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
    • A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
    • A61B5/0833—Measuring rate of oxygen consumption
    • 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
    • A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
    • A61B5/0836—Measuring rate of CO2 production
    • 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
    • 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
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • 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
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A61M16/0672—Nasal cannula assemblies for oxygen therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0024—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system for multiple sensor units attached to the patient, e.g. using a body or personal area network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • 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
    • A61B5/082—Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb occurring during breathing
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • 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
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/435—Composition of exhalation partial O2 pressure (P-O2)
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/50—Temperature

Definitions

  • the invention relates to a device and an installation for monitoring a home oxygen treatment.
  • Oxygen therapy is a treatment consisting in administering to a patient in need, an oxygen-rich gas, for example pure oxygen or a 0 2 / air mixture, so as to maintain or restore his blood oxygen level. .
  • This treatment makes it possible to accompany patients suffering from certain respiratory pathologies, such as Chronic Obstructive Pulmonary Diseases (COPD), and thus to improve their quality and life expectancy.
  • COPD Chronic Obstructive Pulmonary Diseases
  • Oxygen therapy treatment is usually performed at home, that is to say in the patient. Therefore, monitoring patients at home is necessary, even essential, in order to assess the effectiveness of treatment that is closely related to the duration of daily oxygen consumption by patients.
  • an effective follow-up of the patient is essential to ensure the observance of the treatment by the patient, that is to say to determine the duration during the day during which he actually takes his treatment. oxygen therapy, and then to evaluate the actual effectiveness of the treatment on the patient.
  • monitoring and remote monitoring devices have been developed and some are already commercially available. These devices all operate according to more or less the same principle, namely measurement of pressure inside the conduit connecting the oxygen source to the airways of the patient, or directly at the level of the cannula distributing oxygen to the airways. of the patient, and / or by measuring the flow in the duct or in the cannula. The pressure and / or flow measurements make it possible to detect the presence of an oxygen flow rate and the breathing of the patient.
  • Some of these devices have a mode of operation based on measurement at a single point, that is to say near the gas source or in the middle of the duct of the cannula, of various physical quantities, mainly the pressure.
  • the signal from the oxygen-rich gas source ie the gas flow
  • the signal from the patient ie breathing
  • the patient may be considered by the tracking device as 'present' when in reality there is only the source of branch gas and the patient is absent or not connected to the patient. breathing gas delivery system.
  • Other devices use dual lumen cannulas.
  • one of the two ducts of the cannula is used to pass oxygen to the outlet of the cannula.
  • This conduit is connected to the monitoring device on a connector connected to a pipe passing through the device. At the inlet of this pipe is connected the pipe coming from the source of oxygen.
  • the hose is equipped with a pressure and / or flow sensor.
  • the other conduit is connected to the monitoring device on a connector connected to a pressure sensor embedded in the monitoring device. The analysis of the signal measured by this sensor makes it possible to detect the breathing of a patient without being disturbed by the disturbances of the oxygen source. But double lumen cannulas, because they are more expensive, are less numerous and less diversified than simple cannulas.
  • the treatment will be less effective or the patient will not adhere to its treatment.
  • some sources of oxygen valve demand require to be connected to the second conduit of a double lumen cannula.
  • the monitoring device will not work: the second conduit will not be connected to the on-board pressure sensor and the device will no longer detect the patient's breathing.
  • the problem then is to propose a device for monitoring an improved home oxygen therapy.
  • the solution is a device for monitoring the observance of an oxygen therapy treatment comprising: i) a nasal cannula for feeding a patient's nostrils with oxygen-rich gas,
  • a unit of measurement and data transmission arranged on or at the level of the nasal cannula comprising:
  • a pressure sensor and a temperature sensor adapted to and designed to obtain raw pressure and temperature measurement data measured by said sensors
  • a first data transmission system adapted to and adapted to transmit the raw measurement data measured by said sensors to a data acquisition and processing unit
  • a data acquisition and processing unit comprising:
  • a second data transmission system adapted to and adapted to transmit all or part of the raw measurement data and measurement data processed by the analysis algorithm to at least one remote data receiving device.
  • the device of the invention may comprise one or more of the following technical characteristics:
  • the pressure and temperature sensors are adapted to and designed to obtain raw pressure and temperature measurement data, and to convert them into electric pressure and temperature signals.
  • the nasal cannula is fluidly connected to at least one flexible gas supply duct.
  • the first data transmission system and / or the second data transmission system comprise a transmitting antenna, preferably an emitting antenna having a range of several meters.
  • the data acquisition and processing unit comprises at least one microprocessor.
  • the data acquisition and processing unit comprises at least one data storage memory.
  • the data acquisition and processing unit comprises a box comprising the analysis algorithm and the second data transmission system.
  • the pressure and temperature sensors are adapted to and designed to obtain raw pressure and temperature measurement data, and to convert them into electric pressure and temperature signals, respectively.
  • the measurement and data transmission unit further comprises a C0 2 or 0 2 concentration sensor, or an acceleration sensor, and the first data transmission system is adapted to and designed to transmit the data.
  • the first data transmission system is adapted to and designed to transmit the data.
  • the sensors for pressure, temperature and C0 2 or O 2 concentration, or for acceleration are suitable for and designed to obtain raw data for measuring pressure, temperature and concentration in C0 2 or in 0 2 , or acceleration, and to convert them into electrical signals of pressure, temperature and concentration in C0 2 or 0 2 , or acceleration, respectively.
  • the first data transmission system comprises a microprocessor capable of filtering or averaging the raw data.
  • the invention also relates to an oxygen therapy installation comprising a device for monitoring the observance of an oxygen therapy treatment according to the invention; and a remote data receiving device cooperating with the data acquisition and processing unit of the compliance tracking device.
  • the remote data receiving device comprises a server.
  • the data can be stored, transformed, analyzed, converted, displayed, edited, consulted, used to create reports, diagnoses, curves, graphs, tables, etc.
  • FIG. 1 shows a schematic view of an embodiment of a device for monitoring the compliance of an oxygen therapy treatment according to the present invention
  • - Figure 2 shows a schematic view of the device of Figure 1 carried by a patient and its cooperation with the other components of an installation according to the invention
  • FIG. 3 shows the pressure signal differences existing at various sites of the oxygen supply cannula.
  • Figure 1 schematizes an embodiment of a device for monitoring the compliance of an oxygen therapy treatment according to the present invention. It comprises a nasal cannula 1 for feeding a patient's nostrils into a gas rich in oxygen, by means of two expansions or tips 14, 15 which is positioned inside the nostrils of the patient.
  • the nasal cannula 1 is hollow and is fed with a gas rich in oxygen by means of a flexible gas supply conduit 10 fluidly connecting a source of oxygen-rich gas, such as an oxygen bottle (not shown), to the cannula nasale 1.
  • a source of oxygen-rich gas such as an oxygen bottle (not shown)
  • the flexible conduit 10 is connected to the gas source through a connector 16 located at its upstream end.
  • a measurement and data transmission unit 2 is arranged on or at the level, that is to say, in the immediate vicinity or in the region, of the nasal cannula 1.
  • the unit of measurement and data transmission 2 and the cannula 1 are integral with each other.
  • This measurement and data transmission unit 2 comprises a combination of several sensors, namely at least one pressure sensor and a temperature sensor, and optionally a concentration sensor in C0 2 and / or in 0 2 and / or a acceleration sensor.
  • the measurements taken by this unit 2 can make it possible to detect the patient's breathing and / or activity.
  • the sensors of the unit 2 making it possible to carry out pressure and temperature measurements, and possibly C0 2 or O 2 concentration and / or acceleration, and / or capacity measurements at the level of the nasal cannula 1, therefore closer to the patient.
  • this information or raw data of measurement of pressure and temperature, and optionally concentration of C0 2 or 0 2 and / or acceleration, and / or capacity, are converted into electrical signals which are then transmitted by a first data transmission system, preferably integrated in the unit 2.
  • This first data transmission system comprises for example a microprocessor which can handle a first raw data processing such as filtering or averaging, and a short-range antenna, for example a range of a few meters.
  • a microprocessor which can handle a first raw data processing such as filtering or averaging, and a short-range antenna, for example a range of a few meters.
  • the transmission is done for example in radio-frequency or acoustic mode (SAW or ultrasound).
  • SAW radio-frequency or acoustic mode
  • the energy required for measurements and data transmission can be provided by integrated son directly in the cannula 1 and connected at the other end to a power source, but preferably by a unit of energy recovery which can be a mechanical energy recovery unit, for example via a transducer that transforms the vibratory energy of a micro-beam into electric current, or a radiation energy recovery unit, for example via a transducer that transforms RF or acoustic wave energy or ultrasonic energy.
  • a unit of energy recovery which can be a mechanical energy recovery unit, for example via a transducer that transforms the vibratory energy of a micro-beam into electric current, or a radiation energy recovery unit, for example via a transducer that transforms RF or acoustic wave energy or ultrasonic energy.
  • the raw data are collected and processed in a data acquisition and processing unit 3 situated at a distance from the nasal cannula 1.
  • an analysis algorithm 4 makes it possible to collect the raw measurement data transmitted by the data transmission system and to process them for obtain processed measurement data, which is then transmitted by a second data transmission system.
  • the second data transmission system 5 is adapted to and designed to transmit the raw measurement data and / or measurement data processed by the analysis algorithm to at least one remote data receiving device 6 , like a remote server where they can be processed, stored ...
  • the transmission is done for example on the GPRS mode, or by writing the data on an SD card which can then be read on a computer or PC, portable or not, or by a system capable of automatically transmitting the data to the remote data receiving device, such as a remote server.
  • This housing 3 can be completely deported away from the patient, for example on or at the source of gas, be worn by the patient. It may contain one or more pressure sensors, and optionally flow and / or acceleration.
  • the device of the invention is equipped with a conduit passing through it, and pneumatic connectors compatible with the oxygen tubes and cannulas at each end.
  • the flow of oxygen from the source passes through the housing through this conduit.
  • the sensors are either disposable, in the same way as the cannula 1, either disinfectable, that is to say sterilizable, and therefore reusable. In both cases, they can be mounted on any cannula 1. If they are disinfectable and / or sterilizable, they must be disassembled and they must be protected by a gel or membrane type Gore-Tex TM for example, supporting disinfection without disturbing the measurement.
  • the measuring unit 2 is for example equipped with a needle allowing it to pierce the cannula 1 so that the sensor (s) can (s) perform measurements of the characteristics of the gas inside the cannula.
  • the two measurement units are equipped with rings enabling them to be attached and possibly detached from the cannula 1.
  • the rings as well as the sensors must be covered with a material that is comfortable for the patient.
  • a box 3 allowing the recording of the data and their transmission, comprising an algorithm microprocessor 4, a memory chip making it possible to record all or part of the raw and / or processed data, a radio frequency antenna 7 to ensure the wireless transmission of raw or processed data and the supply of the measurement unit if it is powered by an RF type energy recovery unit, and a battery 8 allowing to the system to operate in total autonomy.
  • the battery 8 can be rechargeable or simply via a power outlet that can be connected directly to the mains, when the housing 3 is completely remote from the patient, either by induction or via a power outlet associated with the pneumatic connector when the housing 3 is carried by the patient and is equipped with a conduit therethrough. In the latter case, the pipe 10 connecting the source of oxygen to the patient will integrate a power supply wire which is connected on the source side to the mains.
  • FIG. 2 schematizes the operation of a device according to the invention, in particular the transmission of data between the different elements or units, when said device according to the invention equips a patient 20.
  • the information or data of the pressure and temperature type, and optionally of content C0 2 or 0 2 , capacity and / or acceleration, are measured by sensors located on the cannula 1 supplying the patient 20 oxygen from a source of oxygen is fixed 18 or mobile 17, such as a small bottle of ambulatory oxygen.
  • This housing 3 is arranged at a distance from the cannula 1.
  • the flexible conduit 10 conveying the oxygen-rich gas, such as pure oxygen, from the oxygen source 17, 18 to the nasal cannula 1 feeding the nasal airways of the patient 20, or if appropriate on one or other of the oxygen sources 17, 18.
  • the housing 3 may itself also measure other pressure data and / or flow and / or acceleration data. It can, after acquisition and / or reception of the raw data, store them in raw form and further process them by means of an appropriate analysis algorithm to obtain processed measurement data which can in turn be stored and / or transmitted by a second data transmission system 5 internal to the housing 3.
  • the pressure and temperature, and / or CO 2 and / or O 2 or other data measured on the measurement unit 2 can be stored over a buffer period of at least 30 sec, for example 1 min or more.
  • the stored data can be filtered to remove any disturbance due to the environment.
  • the detection of the breathing of a patient is deduced from the variation of at least one of these data during the buffer period. Then an algorithm, for example comprising FFT type components, is applied to the stored data to deduce the average and maximum respiratory rate.
  • an algorithm for example comprising FFT type components
  • the acceleration data measured on the measurement unit 2 or in the housing 3 are stored over a buffer period, for example 1 min.
  • Indicators of the activity level are calculated from these data, for example the signal "magnitude vector”, and / or the signal “magnitude area”, and / or the average, and / or the standard deviation, and / or the variance. These activity indicators are then compared with thresholds determined experimentally according to the levels of activity that must be detected: at rest, in activity, sitting, lying, etc.
  • the pressure and / or flow rate data measured in the housing 3 are stored over a buffer period, for example 6 sec. The average of these values is calculated and we deduce the presence or absence of a flow of oxygen and possibly the value of this flow of oxygen.
  • All or part of the raw measurement data and / or processed measurement data are then sent to at least one remote data receiving device, in particular to a server or the like where they are stored and subsequently used to determine if the Patient 20 observes his treatment well and if this treatment is effective.
  • one or two measurement and data transmission units 2 are arranged on the nasal cannula 1 and comprise pressure and temperature sensors, and optionally one or more additional C0 2 or O concentration sensors. 2 , capacity, acceleration or a combination of these. These sensors are battery-free and draw their energy from an external source, that is to say integrated son in the cannula 1 or a power recovery unit.
  • the acquisition unit 3 situated on the patient or distant from / distant from the patient has the capacity to process the collected data with an appropriate analysis algorithm 4, that is to say a software for downloading the data. processed data and raw, and further has a communication means 5 capable of transmitting the information to a remote server 6.
  • the acquisition unit 3 may also be equipped with sensors to supplement the data collected by the nasal cannula unit, for example flow, gas concentration and / or acceleration.
  • Figure 3 shows the pressure signal differences existing at various sites of the oxygen supply cannula. As can be seen, the pressure signal is all the more precise and exploitable as it is measured near the patient 20. The same is true of the temperature signal.
  • the signal is measured at the nose provides a stronger patient pressure signal and a temperature signal than each of these signals when measured at the gas source 17, 18 or between the gas source and the cannula.
  • the pressure and temperature sensors 2 of which are located at the level of the nose, that is to say on the cannula 1, and which communicates with a housing 3 acquisition further placed, for example either on the pipe 10 bringing the gas to the cannula 1, or external to the medical equipment.
  • the device and the installation according to the invention make it possible to considerably improve the monitoring of the compliance of a home oxygen therapy treatment of a patient, that is to say a treatment implemented outside the the hospital, including the patient's home.

Abstract

The invention relates to a device for monitoring the observance of an oxygen therapy treatment including a nasal cannula (1) for supplying oxygen-rich gas to the nostrils of a patient; a unit (2) for measuring and transmitting data arranged on or at the nasal cannula (1), comprising at least one pressure sensor and a temperature sensor and optionally a CO2 concentration, O2 concentration or acceleration sensor, capable of and designed for obtaining raw data of pressure and temperature measurement, or other measurements, and a first data-transmission system capable of and designed for transmitting the raw measurement data measured by said sensor or sensors; and a data acquisition and processing unit (3) including an analysis algorithm (4) for collecting the raw measurement data emitted by the data-transmission system and for processing said raw data in order to obtain processed measurement data, and a second data-transmission system (5) capable of and designed for transmitting all or part of the raw measurement data and the measurement data processed by the analysis algorithm (4), toward at least one remote data-reception device (6).

Description

Dispositif de suivi de l'observance d'un traitement d'oxygénothérapie à domicile  Device for monitoring compliance with a home oxygen therapy treatment
L'invention concerne un dispositif et une installation de suivi d'un traitement d'oxygénothérapie à domicile. The invention relates to a device and an installation for monitoring a home oxygen treatment.
L'oxygénothérapie est un traitement consistant à administrer à un patient en ayant besoin, un gaz riche en oxygène, par exemple de l'oxygène pur ou un mélange 02/air, de manière à maintenir ou à rétablir son taux d'oxygène sanguin. Ce traitement permet d'accompagner les patients souffrant de certaines pathologies respiratoires, telles les Broncho- Pneumopathies Chroniques Obstructives (BPCO), et d'améliorer ainsi leur qualité et leur espérance de vie. Oxygen therapy is a treatment consisting in administering to a patient in need, an oxygen-rich gas, for example pure oxygen or a 0 2 / air mixture, so as to maintain or restore his blood oxygen level. . This treatment makes it possible to accompany patients suffering from certain respiratory pathologies, such as Chronic Obstructive Pulmonary Diseases (COPD), and thus to improve their quality and life expectancy.
Le traitement par oxygénothérapie est généralement mis en œuvre à domicile, c'est-à- dire chez le patient. Dès lors, assurer un suivi des patients à domicile est nécessaire, voire primordial, de manière à pouvoir évaluer l'efficacité du traitement qui est étroitement liée à la durée de consommation d'oxygène quotidienne par les patients.  Oxygen therapy treatment is usually performed at home, that is to say in the patient. Therefore, monitoring patients at home is necessary, even essential, in order to assess the effectiveness of treatment that is closely related to the duration of daily oxygen consumption by patients.
En d'autres termes, un suivi efficace du patient est indispensable pour s'assurer de l'observance du traitement par celui-ci, c'est-à-dire de déterminer la durée pendant la journée pendant laquelle il prend effectivement son traitement d'oxygénothérapie, et pour ensuite pouvoir évaluer l'efficacité réelle du traitement sur le patient considéré.  In other words, an effective follow-up of the patient is essential to ensure the observance of the treatment by the patient, that is to say to determine the duration during the day during which he actually takes his treatment. oxygen therapy, and then to evaluate the actual effectiveness of the treatment on the patient.
Pour ce faire, des dispositifs de suivi et de télésurveillance ont été développés et certains sont d'ores et déjà disponibles dans le commerce. Ces dispositifs fonctionnent tous selon plus ou moins le même principe, à savoir mesure de pression à l'intérieur soit du conduit reliant la source d'oxygène aux voies aériennes du patient, soit directement au niveau de la canule distribuant l'oxygène aux voies aériennes du patient, et/ou par mesure du débit dans le conduit ou dans la canule. Les mesures de pression et/ou de débit permettent de détecter la présence d'un débit d'oxygène et la respiration du patient.  To this end, monitoring and remote monitoring devices have been developed and some are already commercially available. These devices all operate according to more or less the same principle, namely measurement of pressure inside the conduit connecting the oxygen source to the airways of the patient, or directly at the level of the cannula distributing oxygen to the airways. of the patient, and / or by measuring the flow in the duct or in the cannula. The pressure and / or flow measurements make it possible to detect the presence of an oxygen flow rate and the breathing of the patient.
Cependant, les dispositifs de suivi existants présentent un certain nombre de problèmes et inconvénients.  However, existing monitoring devices have a number of problems and disadvantages.
Certains de ces dispositifs ont un mode de fonctionnement reposant sur la mesure en un seul point, c'est-à-dire près de la source de gaz ou au milieu du conduit de la canule, de diverses grandeurs physiques, principalement la pression. Pour ces dispositifs, le signal venant de la source de gaz riche en oxygène (i.e. le débit de gaz) et le signal venant du patient (i.e. la respiration) sont souvent difficiles à séparer. Ceci oblige dès lors à utiliser des plages de fonctionnement réduites et conduit à de fortes imprécisions ou incertitudes de mesure (cf. Figure 3). Par exemple, dans certains cas, le patient peut être considéré par l'appareil de suivi comme 'présent' alors qu'en réalité, il n'y a que la source de gaz de branchée et que le patient est absent ou non relié au système de délivrance de gaz respiratoire. Some of these devices have a mode of operation based on measurement at a single point, that is to say near the gas source or in the middle of the duct of the cannula, of various physical quantities, mainly the pressure. For these devices, the signal from the oxygen-rich gas source (ie the gas flow) and the signal from the patient (ie breathing) are often difficult to separate. This therefore requires the use of reduced operating ranges and leads to high measurement inaccuracies or uncertainties (see Figure 3). For example, in some cases the patient may be considered by the tracking device as 'present' when in reality there is only the source of branch gas and the patient is absent or not connected to the patient. breathing gas delivery system.
Les autres dispositifs utilisent des canules doubles lumen. Dans ce cas, l'un des deux conduits de la canule est utilisé pour faire passer l'oxygène jusqu'à la sortie de la canule. Ce conduit est connecté à l'appareil de monitoring sur un connecteur relié à un tuyau traversant l'appareil. En entrée de ce tuyau est connecté le tuyau venant de la source d'oxygène. Le tuyau est équipé d'un capteur de pression et/ou de débit. L'autre conduit est connecté à l'appareil de monitoring sur un connecteur relié à un capteur de pression embarqué dans l'appareil de monitoring. L'analyse du signal mesuré par ce capteur permet de détecter la respiration d'un patient sans être gêné par les perturbations de la source d'oxygène. Mais les canules doubles lumen, parce qu'elles sont plus chères, sont moins nombreuses et moins diversifiées que les canules simples.  Other devices use dual lumen cannulas. In this case, one of the two ducts of the cannula is used to pass oxygen to the outlet of the cannula. This conduit is connected to the monitoring device on a connector connected to a pipe passing through the device. At the inlet of this pipe is connected the pipe coming from the source of oxygen. The hose is equipped with a pressure and / or flow sensor. The other conduit is connected to the monitoring device on a connector connected to a pressure sensor embedded in the monitoring device. The analysis of the signal measured by this sensor makes it possible to detect the breathing of a patient without being disturbed by the disturbances of the oxygen source. But double lumen cannulas, because they are more expensive, are less numerous and less diversified than simple cannulas.
Dans certains cas, il n'est donc pas possible d'adapter les canules au besoin du patient : le traitement en sera moins efficace ou le patient n'adhérera pas à son traitement.  In some cases, it is therefore not possible to adapt the cannula to the patient's needs: the treatment will be less effective or the patient will not adhere to its treatment.
Par ailleurs, certaines sources d'oxygène à valve à la demande nécessitent d'être reliée au deuxième conduit d'une canule double lumen. Dans ce cas, l'appareil de monitoring ne fonctionnera pas : le deuxième conduit ne sera pas connecté au capteur de pression embarqué et l'appareil ne détectera plus la respiration du patient.  In addition, some sources of oxygen valve demand require to be connected to the second conduit of a double lumen cannula. In this case, the monitoring device will not work: the second conduit will not be connected to the on-board pressure sensor and the device will no longer detect the patient's breathing.
De plus, les systèmes actuels ne détectent souvent que l'observance, alors qu'il est nécessaire de connaître non seulement l'observance du patient pour éventuellement l'accompagner plus dans son traitement mais aussi l'efficacité du traitement pris par le patient.  In addition, current systems often only detect compliance, while it is necessary to know not only the compliance of the patient to possibly accompany more in its treatment but also the effectiveness of the treatment taken by the patient.
Le problème qui se pose alors est de proposer un dispositif de suivi d'un traitement d'oxygénothérapie à domicile amélioré.  The problem then is to propose a device for monitoring an improved home oxygen therapy.
La solution est un dispositif de suivi de l'observance d'un traitement d'oxygénothérapie comprenant : i) une canule nasale permettant d'alimenter les narines d'un patient en un gaz riche en oxygène, The solution is a device for monitoring the observance of an oxygen therapy treatment comprising: i) a nasal cannula for feeding a patient's nostrils with oxygen-rich gas,
ii) une unité de mesure et de transmission de données agencée sur ou au niveau de la canule nasale comportant :  ii) a unit of measurement and data transmission arranged on or at the level of the nasal cannula comprising:
. un capteur de pression et un capteur de température aptes à et conçus pour obtenir des données brutes de mesure de pression et de température mesurées par lesdits capteurs, et  . a pressure sensor and a temperature sensor adapted to and designed to obtain raw pressure and temperature measurement data measured by said sensors, and
. un premier système de transmission de données apte à et conçu pour transmettre les données de mesure brutes mesurées par lesdits capteurs, à une unité d'acquisition et de traitement de données et  . a first data transmission system adapted to and adapted to transmit the raw measurement data measured by said sensors to a data acquisition and processing unit and
iii) une unité d'acquisition et de traitement de données comprenant :  iii) a data acquisition and processing unit comprising:
. un algorithme d'analyse permettant de recueillir les données de mesure brutes émises par le système de transmission de données et de traiter lesdites données brutes pour obtenir des données de mesure traitées,  . an analysis algorithm for collecting the raw measurement data transmitted by the data transmission system and processing said raw data to obtain processed measurement data,
. et un deuxième système de transmission de données apte à et conçu pour transmettre tout ou partie des données de mesure brutes et des données de mesure traitées par l'algorithme d'analyse, vers au moins un dispositif de réception de données distant.  . and a second data transmission system adapted to and adapted to transmit all or part of the raw measurement data and measurement data processed by the analysis algorithm to at least one remote data receiving device.
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:
- les capteurs de pression et de température sont aptes à et conçus pour obtenir des données brutes de mesure de pression et de température, et pour les convertir en signaux électriques de pression et de température.  the pressure and temperature sensors are adapted to and designed to obtain raw pressure and temperature measurement data, and to convert them into electric pressure and temperature signals.
- la canule nasale est raccordée fluidiquement à au moins un conduit souple d'amenée de gaz.  the nasal cannula is fluidly connected to at least one flexible gas supply duct.
- le premier système de transmission de données et/ou le deuxième système de transmission de données comprennent une antenne émettrice, de préférence une antenne émettrice ayant une portée de plusieurs mètres.  the first data transmission system and / or the second data transmission system comprise a transmitting antenna, preferably an emitting antenna having a range of several meters.
- l'unité d'acquisition et de traitement de données comprend au moins un microprocesseur.  the data acquisition and processing unit comprises at least one microprocessor.
- l'unité d'acquisition et de traitement de données comprend au moins une mémoire de stockage de données. - l'unité d'acquisition et de traitement de données comprend un boîtier comportant l'algorithme d'analyse et le deuxième système de transmission de données. the data acquisition and processing unit comprises at least one data storage memory. the data acquisition and processing unit comprises a box comprising the analysis algorithm and the second data transmission system.
- les capteurs de pression et de température sont aptes à et conçus pour obtenir des données brutes de mesure de pression et de température, et pour les convertir en signaux électriques de pression et de température, respectivement.  the pressure and temperature sensors are adapted to and designed to obtain raw pressure and temperature measurement data, and to convert them into electric pressure and temperature signals, respectively.
- l'unité de mesure et de transmission de données comprend en outre un capteur de concentration en C02 ou en 02, ou un capteur d'accélération, et le premier système de transmission de données est apte à et conçu pour transmettre les données de mesure brutes mesurées par lesdits capteurs de concentration en C02 ou en 02, ou d'accélération, à l'unité d'acquisition et de traitement de données. the measurement and data transmission unit further comprises a C0 2 or 0 2 concentration sensor, or an acceleration sensor, and the first data transmission system is adapted to and designed to transmit the data. raw measurement measured by said C0 2 or 0 2 concentration sensors, or acceleration, to the data acquisition and processing unit.
- les capteurs de pression, de température et de concentration en C02 ou en 02, ou d'accélération sont aptes à et conçus pour obtenir des données brutes de mesure de pression, de température et de concentration en C02 ou en 02, ou d'accélération, et pour les convertir en signaux électriques de pression, de température et de concentration en C02 ou en 02, ou d'accélération, respectivement. the sensors for pressure, temperature and C0 2 or O 2 concentration, or for acceleration are suitable for and designed to obtain raw data for measuring pressure, temperature and concentration in C0 2 or in 0 2 , or acceleration, and to convert them into electrical signals of pressure, temperature and concentration in C0 2 or 0 2 , or acceleration, respectively.
- il comprend une source d'énergie électrique alimentant l'unité de mesure et de transmission de données en courant électrique.  it comprises a source of electrical energy supplying the unit of measurement and data transmission with electric current.
- le premier système de transmission de données comprend un microprocesseur apte à opérer un filtrage ou un moyennage des données brutes.  the first data transmission system comprises a microprocessor capable of filtering or averaging the raw data.
Par ailleurs, l'invention concerne aussi une installation d'oxygénothérapie comprenant un dispositif de suivi de l'observance d'un traitement d'oxygénothérapie selon l'invention ; et un dispositif de réception de données distant coopérant avec l'unité d'acquisition et de traitement de données du dispositif de suivi de l'observance.  Furthermore, the invention also relates to an oxygen therapy installation comprising a device for monitoring the observance of an oxygen therapy treatment according to the invention; and a remote data receiving device cooperating with the data acquisition and processing unit of the compliance tracking device.
De préférence, le dispositif de réception de données distant comprend un serveur. Les données peuvent y être notamment mémorisées, transformées, analysées, converties, affichées, éditées, consultées, utilisées pour établir des rapports, un diagnostic, des courbes, des graphes, des tableaux....  Preferably, the remote data receiving device comprises a server. The data can be stored, transformed, analyzed, converted, displayed, edited, consulted, used to create reports, diagnoses, curves, graphs, tables, etc.
La présente invention va maintenant être mieux comprise grâce aux explications suivantes données en références aux Figures annexées parmi lesquelles :  The present invention will now be better understood thanks to the following explanations given with reference to the appended figures among which:
- la Figure 1 représente une vue schématique d'un mode de réalisation d'un dispositif de suivi de l'observance d'un traitement d'oxygénothérapie selon la présente invention ; - la Figure 2 représente une vue schématique du dispositif de la Figure 1 porté par un patient et sa coopération avec les autres composants d'une installation selon l'invention ; et- Figure 1 shows a schematic view of an embodiment of a device for monitoring the compliance of an oxygen therapy treatment according to the present invention; - Figure 2 shows a schematic view of the device of Figure 1 carried by a patient and its cooperation with the other components of an installation according to the invention; and
- la Figure 3 montre les différences de signal de pression existant en divers sites de la canule d'amenée d'oxygène. - Figure 3 shows the pressure signal differences existing at various sites of the oxygen supply cannula.
La Figure 1 schématise un mode de réalisation d'un dispositif de suivi de l'observance d'un traitement d'oxygénothérapie selon la présente invention. Celui-ci comprend une canule nasale 1 permettant d'alimenter les narines d'un patient en un gaz riche en oxygène, par l'intermédiaire de deux expansions ou embouts 14, 15 venant se positionner à l'intérieur des narines du patient.  Figure 1 schematizes an embodiment of a device for monitoring the compliance of an oxygen therapy treatment according to the present invention. It comprises a nasal cannula 1 for feeding a patient's nostrils into a gas rich in oxygen, by means of two expansions or tips 14, 15 which is positioned inside the nostrils of the patient.
La canule nasale 1 est creuse et est alimentée par un gaz riche en oxygène grâce à un conduit souple 10 d'alimentation en gaz reliant fluidiquement une source de gaz riche en oxygène, telle une bouteille d'oxygène (non schématisée), à la canule nasale 1. Le conduit souple 10 vient se connecter sur la source de gaz grâce à un connecteur 16 situé à son extrémité amont.  The nasal cannula 1 is hollow and is fed with a gas rich in oxygen by means of a flexible gas supply conduit 10 fluidly connecting a source of oxygen-rich gas, such as an oxygen bottle (not shown), to the cannula nasale 1. The flexible conduit 10 is connected to the gas source through a connector 16 located at its upstream end.
Dans le mode de réalisation présenté en Figure 1 , le conduit souple 10 se ramifie (en In the embodiment shown in FIG. 1, the flexible duct 10 branched (in
11) en deux sous-conduits 12, 13 venant chacun se raccorder, via leur extrémité aval, à la canule nasale 1 pour amener de l'oxygène à la canule 1 et donc à chacun des embouts 14, 15. 11) in two sub-ducts 12, 13 each coming to connect, via their downstream end, to the nasal cannula 1 to supply oxygen to the cannula 1 and therefore to each of the tips 14, 15.
Toutefois, selon un autre mode de réalisation (non représenté), on peut aussi utiliser une canule 1 dont le conduit d'alimentation 10 ne se ramifie pas et vient se raccorder uniquement d'un côté de la canule 1.  However, according to another embodiment (not shown), it is also possible to use a cannula 1 whose supply duct 10 does not branch and comes to connect only to one side of the cannula 1.
Selon l'invention, on agence une unité de mesure et de transmission de données 2 sur ou au niveau, c'est-à-dire à proximité immédiate ou dans la région, de la canule nasale 1. De préférence, l'unité de mesure et de transmission de données 2 et la canule 1 sont solidaires l'une de l'autre.  According to the invention, a measurement and data transmission unit 2 is arranged on or at the level, that is to say, in the immediate vicinity or in the region, of the nasal cannula 1. Preferably, the unit of measurement and data transmission 2 and the cannula 1 are integral with each other.
Celle unité de mesure et de transmission de données 2 comporte une combinaison de plusieurs capteurs, à savoir au moins un capteur de pression et un capteur de température, et éventuellement un capteur de concentration en C02 et/ou en 02 et/ou un capteur d'accélération. This measurement and data transmission unit 2 comprises a combination of several sensors, namely at least one pressure sensor and a temperature sensor, and optionally a concentration sensor in C0 2 and / or in 0 2 and / or a acceleration sensor.
Les mesures prises par cette unité 2, c'est-à-dire obtenues par les capteurs susmentionnés, peuvent permettre de détecter la respiration du patient et/ou son activité. Les capteurs de l'unité 2 permettant de réaliser des mesures de pression et de température, et éventuellement de concentration en C02 ou d'02 et/ou d'accélération, et/ou de capacité au niveau de la canule nasale 1 , donc au plus près du patient. The measurements taken by this unit 2, that is to say obtained by the above-mentioned sensors, can make it possible to detect the patient's breathing and / or activity. The sensors of the unit 2 making it possible to carry out pressure and temperature measurements, and possibly C0 2 or O 2 concentration and / or acceleration, and / or capacity measurements at the level of the nasal cannula 1, therefore closer to the patient.
Une fois mesurées, ces informations ou données brutes de mesure de pression et de température, et optionnellement de concentration en C02 ou en 02 et/ou d'accélération, et/ou de capacité, sont converties en signaux électriques qui sont transmis ensuite par un premier système de transmission de données, de préférence intégré à l'unité 2. Once measured, this information or raw data of measurement of pressure and temperature, and optionally concentration of C0 2 or 0 2 and / or acceleration, and / or capacity, are converted into electrical signals which are then transmitted by a first data transmission system, preferably integrated in the unit 2.
Ce premier système de transmission de données comprend par exemple un microprocesseur qui peut gérer un premier traitement des données brutes tel qu'un filtrage ou moyennage, et une antenne à courte portée, par exemple d'une portée de quelques mètres.  This first data transmission system comprises for example a microprocessor which can handle a first raw data processing such as filtering or averaging, and a short-range antenna, for example a range of a few meters.
La transmission se fait par exemple sur le mode radio-fréquence ou acoustique (SAW ou ultrason).  The transmission is done for example in radio-frequency or acoustic mode (SAW or ultrasound).
L'énergie nécessaire aux mesures et à la transmission des données peut être apportée par des fils intégrés directement dans la canule 1 et reliés à l'autre bout à une source d'énergie, mais de préférence par une unité de récupération d'énergie qui peut être une unité de récupération d'énergie mécanique, par exemple via un transducteur qui transforme l'énergie vibratoire d'une micro-poutre en courant électrique, ou une unité de récupération d'énergie de rayonnement, par exemple via un transducteur qui transforme l'énergie d'ondes RF ou acoustiques ou d'ultrasons en courant électrique.  The energy required for measurements and data transmission can be provided by integrated son directly in the cannula 1 and connected at the other end to a power source, but preferably by a unit of energy recovery which can be a mechanical energy recovery unit, for example via a transducer that transforms the vibratory energy of a micro-beam into electric current, or a radiation energy recovery unit, for example via a transducer that transforms RF or acoustic wave energy or ultrasonic energy.
Les données brutes sont recueillies et traitées au sein d'une unité 3 d'acquisition et de traitement de données située à distance de la canule nasale 1.  The raw data are collected and processed in a data acquisition and processing unit 3 situated at a distance from the nasal cannula 1.
Au sein de l'unité 3 d'acquisition et de traitement de données, encore appelé boîtier d'acquisition, un algorithme d'analyse 4 permet de recueillir les données de mesure brutes émises par le système de transmission de données et de les traiter pour obtenir des données de mesure traitées, qui sont ensuite transmises par un deuxième système 5 de transmission de données.  Within the data acquisition and processing unit 3, also called an acquisition box, an analysis algorithm 4 makes it possible to collect the raw measurement data transmitted by the data transmission system and to process them for obtain processed measurement data, which is then transmitted by a second data transmission system.
En fait, le deuxième système 5 de transmission de données est apte à et conçu pour transmettre les données de mesure brutes et/ou des données de mesure traitées par l'algorithme d'analyse, vers au moins un dispositif de réception 6 de données distant, tel un serveur distant où elles peuvent être traitées, stockées... Dans ce deuxième système de transmission 5 de données, la transmission se fait par exemple sur le mode GPRS, ou bien par écriture des données sur une carte SD qui peut ensuite être lue sur un ordinateur ou PC, portable ou non, ou par un système capable de transmettre automatiquement les données vers le dispositif de réception de données distant, tel un serveur distant. In fact, the second data transmission system 5 is adapted to and designed to transmit the raw measurement data and / or measurement data processed by the analysis algorithm to at least one remote data receiving device 6 , like a remote server where they can be processed, stored ... In this second data transmission system, the transmission is done for example on the GPRS mode, or by writing the data on an SD card which can then be read on a computer or PC, portable or not, or by a system capable of automatically transmitting the data to the remote data receiving device, such as a remote server.
L'idée est donc d'utiliser plusieurs capteurs aussi discrets que possibles, agencés directement sur la canule 1 et communiquant avec un boîtier d'acquisition adapté, c'est-à-dire l'unité 3. Ce boîtier 3 peut être complètement déporté loin du patient, par exemple sur ou au niveau de la source de gaz, soit porté par le patient. Il peut contenir un ou des capteurs de pression, et optionnellement de débit et/ou d'accélération.  The idea is therefore to use several sensors as discrete as possible, arranged directly on the cannula 1 and communicating with a suitable acquisition box, that is to say the unit 3. This housing 3 can be completely deported away from the patient, for example on or at the source of gas, be worn by the patient. It may contain one or more pressure sensors, and optionally flow and / or acceleration.
Dans le cas de capteurs de pression et/ou de débit, le dispositif de l'invention est équipé d'un conduit le traversant, et de connecteurs pneumatiques compatibles avec les tuyaux et canules à oxygène à chaque bout. Le flux d'oxygène provenant de la source traverse le boîtier par ce conduit.  In the case of pressure and / or flow sensors, the device of the invention is equipped with a conduit passing through it, and pneumatic connectors compatible with the oxygen tubes and cannulas at each end. The flow of oxygen from the source passes through the housing through this conduit.
Les capteurs sont soit jetables, au même titre que la canule 1 , soit désinfectables, c'est- à-dire stérilisables, et donc réutilisables. Dans les deux cas, ils peuvent être montés sur n'importe quelle canule 1. S'ils sont désinfectables et/ou stérilisables, ils doivent pouvoir être démontés et ils doivent être protégés par un gel ou une membrane, de type Gore-Tex™ par exemple, supportant la désinfection sans gêner la mesure.  The sensors are either disposable, in the same way as the cannula 1, either disinfectable, that is to say sterilizable, and therefore reusable. In both cases, they can be mounted on any cannula 1. If they are disinfectable and / or sterilizable, they must be disassembled and they must be protected by a gel or membrane type Gore-Tex ™ for example, supporting disinfection without disturbing the measurement.
L'unité de mesure 2 est par exemple équipée d'une aiguille lui permettant de percer la canule 1 afin que le ou les capteur(s) puisse(nt) réaliser des mesures des caractéristiques du gaz à l'intérieur de la canule. Les deux unités de mesures sont équipées de bagues leur permettant d'être attachées et éventuellement détachées de la canule 1. Les bagues ainsi que les capteurs doivent être recouvert d'un matériau confortable pour le patient.  The measuring unit 2 is for example equipped with a needle allowing it to pierce the cannula 1 so that the sensor (s) can (s) perform measurements of the characteristics of the gas inside the cannula. The two measurement units are equipped with rings enabling them to be attached and possibly detached from the cannula 1. The rings as well as the sensors must be covered with a material that is comfortable for the patient.
Comme schématisé en Figure 1 , on peut utiliser un boîtier 3 permettant l'enregistrement des données et leur transmission, comprenant un micro-processeur à algorithme 4, une puce mémoire permettant d'enregistrer tout ou partie des données brutes et/ou traitées, une antenne radio fréquence 7 permettant d'assurer la transmission sans fil des données brutes ou traitées et l'alimentation de l'unité de mesure si celle-ci est alimentée par une unité de récupération d'énergie de type RF, et une batterie 8 permettant au système de fonctionner en totale autonomie. La batterie 8 peut être rechargeable soit simplement via une prise d'alimentation qui peut être branchée directement au secteur, lorsque ce boîtier 3 est complètement déporté du patient, soit par induction, soit via une prise d'alimentation associée au connecteur pneumatique lorsque ce boîtier 3 est porté par le patient et qu'il est équipé d'un conduit le traversant. Dans ce dernier cas, le tuyau 10 reliant la source d'oxygène au patient intégrera un fil d'alimentation électrique qui est relié, côté source, au secteur. As shown diagrammatically in FIG. 1, it is possible to use a box 3 allowing the recording of the data and their transmission, comprising an algorithm microprocessor 4, a memory chip making it possible to record all or part of the raw and / or processed data, a radio frequency antenna 7 to ensure the wireless transmission of raw or processed data and the supply of the measurement unit if it is powered by an RF type energy recovery unit, and a battery 8 allowing to the system to operate in total autonomy. The battery 8 can be rechargeable or simply via a power outlet that can be connected directly to the mains, when the housing 3 is completely remote from the patient, either by induction or via a power outlet associated with the pneumatic connector when the housing 3 is carried by the patient and is equipped with a conduit therethrough. In the latter case, the pipe 10 connecting the source of oxygen to the patient will integrate a power supply wire which is connected on the source side to the mains.
La Figure 2 schématise le fonctionnement d'un dispositif selon l'invention, en particulier la transmission des données entre les différents éléments ou unités, lorsque ledit dispositif selon l'invention équipe un patient 20.  FIG. 2 schematizes the operation of a device according to the invention, in particular the transmission of data between the different elements or units, when said device according to the invention equips a patient 20.
Comme on le voit, les informations ou données de type pression et température, et éventuellement de teneur en C02 ou en 02, de capacité et/ou d'accélération, sont mesurées par des capteurs situés sur la canule 1 alimentant le patient 20 en oxygène provenant d'une source d'oxygène soit fixe 18, soit mobile 17, telle une petite bouteille d'oxygène ambulatoire. As can be seen, the information or data of the pressure and temperature type, and optionally of content C0 2 or 0 2 , capacity and / or acceleration, are measured by sensors located on the cannula 1 supplying the patient 20 oxygen from a source of oxygen is fixed 18 or mobile 17, such as a small bottle of ambulatory oxygen.
Les données ainsi recueillies sont ensuite transmises au boîtier 3 faisant office d'unité d'acquisition et de traitement de données. Ce boîtier 3 est agencé à distance de la canule 1. Par exemple, il peut être agencé sur le conduit flexible 10 acheminant le gaz riche en oxygène, tel de l'oxygène pur, depuis la source d'oxygène 17, 18 jusqu'à la canule nasale 1 alimentant les voies aériennes nasales du patient 20, ou le cas échéant sur l'une ou l'autre des sources d'oxygène 17, 18.  The data thus collected are then transmitted to the housing 3 acting as a data acquisition and processing unit. This housing 3 is arranged at a distance from the cannula 1. For example, it can be arranged on the flexible conduit 10 conveying the oxygen-rich gas, such as pure oxygen, from the oxygen source 17, 18 to the nasal cannula 1 feeding the nasal airways of the patient 20, or if appropriate on one or other of the oxygen sources 17, 18.
Le boîtier 3 peut lui-même aussi mesurer d'autres données de pression et/ou des données de débit et/ou d'accélération. Il peut, après acquisition et/ou réception des données brutes, les stocker sous forme brute et par ailleurs les traiter au moyen d'un algorithme d'analyse approprié pour obtenir des données de mesure traitées qui peuvent à leur tour être stockées et/ou émises par un deuxième système de transmission de données 5 interne au boîtier 3.  The housing 3 may itself also measure other pressure data and / or flow and / or acceleration data. It can, after acquisition and / or reception of the raw data, store them in raw form and further process them by means of an appropriate analysis algorithm to obtain processed measurement data which can in turn be stored and / or transmitted by a second data transmission system 5 internal to the housing 3.
Les données de pression et de température, et/ou de teneur en C02 et/ou en 02 ou autres, mesurées sur l'unité de mesure 2 peuvent être mémorisées sur une période tampon d'au moins 30 sec, par exemple de 1 min ou plus. Les données mémorisées pourront être filtrées pour supprimer toute perturbation due à l'environnement. The pressure and temperature, and / or CO 2 and / or O 2 or other data measured on the measurement unit 2 can be stored over a buffer period of at least 30 sec, for example 1 min or more. The stored data can be filtered to remove any disturbance due to the environment.
La détection de la respiration d'un patient est déduite de la variation d'au moins une de ces données pendant la période tampon. Puis un algorithme, par exemple comprenant des composantes de type FFT, est appliqué à ou aux données mémorisées pour en déduire la fréquence respiratoire moyenne et maximale. The detection of the breathing of a patient is deduced from the variation of at least one of these data during the buffer period. Then an algorithm, for example comprising FFT type components, is applied to the stored data to deduce the average and maximum respiratory rate.
Les données d'accélération mesurées sur l'unité de mesure 2 ou dans le boîtier 3 sont mémorisées sur une période tampon, par exemple 1 min.  The acceleration data measured on the measurement unit 2 or in the housing 3 are stored over a buffer period, for example 1 min.
Des indicateurs du niveau d'activité sont calculés à partir de ces données, par exemple le signal « magnitude vector » (vecteur magnitude), et/ou le signal « magnitude area » (aire de magnitude), et/ou la moyenne, et/ou l'écart type, et/ou la variance. Ces indicateurs d'activités sont ensuite comparés à des seuils fixés expérimentalement en fonction des niveaux d'activité qu'il faut détecter : au repos, en activité, assis, allongé, etc.  Indicators of the activity level are calculated from these data, for example the signal "magnitude vector", and / or the signal "magnitude area", and / or the average, and / or the standard deviation, and / or the variance. These activity indicators are then compared with thresholds determined experimentally according to the levels of activity that must be detected: at rest, in activity, sitting, lying, etc.
Les données de pression et/ou de débit mesurées dans le boîtier 3 sont mémorisées sur une période tampon, par exemple 6 sec. La moyenne de ces valeurs est calculée et on en déduit la présence ou non d'un débit d'oxygène et éventuellement la valeur de ce débit d'oxygène.  The pressure and / or flow rate data measured in the housing 3 are stored over a buffer period, for example 6 sec. The average of these values is calculated and we deduce the presence or absence of a flow of oxygen and possibly the value of this flow of oxygen.
Tout ou partie des données de mesure brutes et/ou des données de mesure traitées sont alors envoyés vers au moins un dispositif de réception de données distant, en particulier vers un serveur ou analogue où elles sont conservées et utilisées par la suite pour déterminer si le patient 20 observe bien son traitement et si ce traitement est efficace.  All or part of the raw measurement data and / or processed measurement data are then sent to at least one remote data receiving device, in particular to a server or the like where they are stored and subsequently used to determine if the Patient 20 observes his treatment well and if this treatment is effective.
En d'autres termes, une ou deux unités de mesure et de transmission de données 2 sont agencées sur la canule nasale 1 et comportent des capteurs de pression et de température, et éventuellement un ou des capteurs supplémentaires de concentration en C02 ou en 02, de capacité, d'accélération ou une combinaison de ceux-ci. Ces capteurs sont sans batterie et puisent leur énergie d'une source externe, c'est-à-dire de fils intégrés dans la canule 1 ou d'une unité de récupération d'énergie. In other words, one or two measurement and data transmission units 2 are arranged on the nasal cannula 1 and comprise pressure and temperature sensors, and optionally one or more additional C0 2 or O concentration sensors. 2 , capacity, acceleration or a combination of these. These sensors are battery-free and draw their energy from an external source, that is to say integrated son in the cannula 1 or a power recovery unit.
Par ailleurs, l'unité d'acquisition 3 située sur le patient ou éloignée/distante du patient, a la capacité de traiter les données recueillies avec un algorithme 4 d'analyse approprié, c'est- à-dire un logiciel de téléchargement des données traitées et brutes, et possède en outre un moyen de communication 5 capable de transmettre les informations à un serveur distant 6.  Moreover, the acquisition unit 3 situated on the patient or distant from / distant from the patient, has the capacity to process the collected data with an appropriate analysis algorithm 4, that is to say a software for downloading the data. processed data and raw, and further has a communication means 5 capable of transmitting the information to a remote server 6.
L'unité d'acquisition 3 peut également être équipée de capteurs pour compléter les données recueillies par l'unité canule nasale, par exemple débit, concentration en gaz et/ou accélération. Par ailleurs, la Figure 3 représente les différences de signal de pression existant en divers sites de la canule d'amenée d'oxygène. Comme on le voit, le signal de pression est d'autant plus précis et exploitable qu'il est mesuré à proximité du patient 20. Il en va de même du signal de température. The acquisition unit 3 may also be equipped with sensors to supplement the data collected by the nasal cannula unit, for example flow, gas concentration and / or acceleration. Furthermore, Figure 3 shows the pressure signal differences existing at various sites of the oxygen supply cannula. As can be seen, the pressure signal is all the more precise and exploitable as it is measured near the patient 20. The same is true of the temperature signal.
Le fait que l'on mesure le signal au niveau du nez permet d'obtenir un signal patient de pression et un signal de température plus forts que chacun de ces signaux lorsqu'il est mesuré au niveau de la source de gaz 17, 18 ou entre la source de gaz et la canule.  The fact that the signal is measured at the nose provides a stronger patient pressure signal and a temperature signal than each of these signals when measured at the gas source 17, 18 or between the gas source and the cannula.
Ceci permet dès lors de bien comprendre l'intérêt du dispositif selon la présente invention dont les capteurs de pression et de température 2 sont situés au niveau du nez, c'est- à-dire sur la canule 1 , et qui communique avec un boîtier d'acquisition 3 placé plus loin, par exemple soit sur le conduit 10 amenant le gaz à la canule 1 , soit externe à l'équipement médical.  This therefore makes it possible to clearly understand the advantage of the device according to the present invention, the pressure and temperature sensors 2 of which are located at the level of the nose, that is to say on the cannula 1, and which communicates with a housing 3 acquisition further placed, for example either on the pipe 10 bringing the gas to the cannula 1, or external to the medical equipment.
En fait, le fait que les capteurs 2 de pression et de température, voire d'autres capteurs, soient situés près du patient permet d'amplifier le signal « patient » par rapport au signal au niveau de la source de gaz 17, 18, et donc facilite leur séparation et l'analyse qui en découle.  In fact, the fact that the pressure and temperature sensors 2 and even other sensors are located near the patient makes it possible to amplify the "patient" signal with respect to the signal at the source of gas 17, 18, and therefore facilitates their separation and the analysis that follows from it.
En effet, ce sont les variations du signal patient qui sont intéressantes et doivent être exploitées pour en déduire la respiration du patient, les périodes de respiration par la bouche et la fréquence respiratoire du patient.  Indeed, it is the variations of the patient signal that are interesting and must be exploited to deduce the patient's breathing, the periods of breathing by the mouth and the respiratory rate of the patient.
Se placer juste à la naissance de ce signal permet donc de s'affranchir de la gêne occasionnée par la source de gaz 17, 18 que l'on observe généralement lorsque les capteurs sont placés sur le conduit 10 arrivant à la canule 1 à mi-chemin entre le patient 20 et la source de gaz 17, 18.  Positioning itself just at the birth of this signal thus makes it possible to overcome the inconvenience caused by the gas source 17, 18 that is generally observed when the sensors are placed on the conduit 10 arriving at the cannula 1 at mid-point. path between the patient 20 and the gas source 17, 18.
Le dispositif et l'installation selon l'invention permettent d'améliorer considérablement le suivi de l'observance d'un traitement d'oxygénothérapie à domicile d'un patient, c'est-à-dire un traitement mis en œuvre en dehors de l'hôpital, notamment au domicile du patient.  The device and the installation according to the invention make it possible to considerably improve the monitoring of the compliance of a home oxygen therapy treatment of a patient, that is to say a treatment implemented outside the the hospital, including the patient's home.

Claims

Revendications claims
1. Dispositif de suivi de l'observance d'un traitement d'oxygénothérapie comprenant : A device for monitoring compliance with an oxygen therapy treatment comprising:
i) une canule nasale (1) permettant d'alimenter les narines d'un patient en un gaz riche en oxygène,  i) a nasal cannula (1) for feeding a patient's nostrils with an oxygen-rich gas,
ii) une unité de mesure et de transmission de données (2) agencée sur ou au niveau de la canule nasale (1) comportant :  ii) a measurement and data transmission unit (2) arranged on or at the level of the nasal cannula (1) comprising:
. un capteur de pression et un capteur de température aptes à et conçus pour obtenir des données brutes de mesure de pression et de température mesurées par lesdits capteurs, et  . a pressure sensor and a temperature sensor adapted to and designed to obtain raw pressure and temperature measurement data measured by said sensors, and
. un premier système de transmission de données apte à et conçu pour transmettre les données de mesure brutes mesurées par lesdits capteurs, à une unité d'acquisition et de traitement de données (3) et  . a first data transmission system adapted to and designed to transmit the raw measurement data measured by said sensors to a data acquisition and processing unit (3) and
iii) une unité d'acquisition et de traitement de données (3) comprenant :  iii) a data acquisition and processing unit (3) comprising:
. un algorithme d'analyse (4) permettant de recueillir les données de mesure brutes émises par le système de transmission de données et de traiter lesdites données brutes pour obtenir des données de mesure traitées, et  . an analysis algorithm (4) for collecting the raw measurement data transmitted by the data transmission system and processing said raw data to obtain processed measurement data, and
. un deuxième système de transmission de données (5) apte à et conçu pour transmettre tout ou partie des données de mesure brutes et des données de mesure traitées par l'algorithme d'analyse (4), vers au moins un dispositif de réception de données distant (6).  . a second data transmission system (5) adapted to and adapted to transmit all or part of the raw measurement data and measurement data processed by the analysis algorithm (4) to at least one data receiving device remote (6).
2. Dispositif selon la revendication précédente, caractérisé en ce que les capteurs de pression et de température sont aptes à et conçus pour obtenir des données brutes de mesure de pression et de température, et pour les convertir en signaux électriques de pression et de température. 2. Device according to the preceding claim, characterized in that the pressure and temperature sensors are adapted to and designed to obtain raw data for measuring pressure and temperature, and to convert them into electric pressure and temperature signals.
3. Dispositif selon l'une des revendications précédentes, caractérisé en ce que la canule nasale (1) est raccordée fluidiquement à au moins un conduit souple (10, 12, 13) d'amenée de gaz. 3. Device according to one of the preceding claims, characterized in that the nasal cannula (1) is fluidly connected to at least one flexible conduit (10, 12, 13) of gas supply.
4. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le premier système de transmission de données et/ou le deuxième système de transmission de données (5) comprennent une antenne émettrice. 4. Device according to one of the preceding claims, characterized in that the first data transmission system and / or the second data transmission system (5) comprises a transmitting antenna.
5. Dispositif selon l'une des revendications précédentes, caractérisé en ce que l'unité d'acquisition et de traitement de données (3) comprend un microprocesseur et/ou une mémoire de stockage de données. 5. Device according to one of the preceding claims, characterized in that the data acquisition and processing unit (3) comprises a microprocessor and / or a data storage memory.
6. Dispositif selon l'une des revendications précédentes, caractérisé en ce que l'unité d'acquisition et de traitement de données (3) comprend un boîtier comportant l'algorithme d'analyse (4) et le deuxième système de transmission de données (5). 6. Device according to one of the preceding claims, characterized in that the data acquisition and processing unit (3) comprises a housing comprising the analysis algorithm (4) and the second data transmission system. (5).
7. Dispositif selon l'une des revendications précédentes, caractérisé en ce que :7. Device according to one of the preceding claims, characterized in that:
- l'unité de mesure et de transmission de données (2) comprend en outre un capteur de concentration en C02 ou en 02, ou un capteur d'accélération, et the measurement and data transmission unit (2) further comprises a concentration sensor in C0 2 or in 0 2 , or an acceleration sensor, and
- le premier système de transmission de données est apte à et conçu pour transmettre les données de mesure brutes mesurées par lesdits capteurs de concentration en C02 ou en 02, ou d'accélération, à l'unité d'acquisition et de traitement de données (3). the first data transmission system is adapted to and designed to transmit the raw measurement data measured by said C0 2 or 0 2 concentration or acceleration sensors to the acquisition and processing unit of data (3).
8. Dispositif selon l'une des revendications précédentes, caractérisé en ce qu'il comprend une source d'énergie électrique alimentant l'unité de mesure et de transmission de données (2) en courant électrique. 8. Device according to one of the preceding claims, characterized in that it comprises a source of electrical power supplying the measurement unit and data transmission (2) in electric current.
9. Dispositif selon l'une des revendications précédentes, caractérisé en ce que le premier système de transmission de données comprend un microprocesseur apte à opérer un filtrage ou un moyennage des données brutes. 9. Device according to one of the preceding claims, characterized in that the first data transmission system comprises a microprocessor capable of filtering or averaging the raw data.
10. Dispositif selon l'une des revendications précédentes, caractérisé en ce que l'unité de mesure et de transmission de données (2) et la canule (1) sont solidaires l'une de l'autre. 10. Device according to one of the preceding claims, characterized in that the measuring unit and data transmission (2) and the cannula (1) are integral with each other.
11. Installation d'oxygénothérapie comprenant : 11. Oxygen therapy facility comprising:
- un dispositif de suivi de l'observance d'un traitement d'oxygénothérapie selon l'une des revendications précédentes; et  a device for monitoring the observance of an oxygen therapy treatment according to one of the preceding claims; and
- un dispositif de réception de données distant (6) coopérant avec l'unité d'acquisition et de traitement de données (3) du dispositif de suivi de l'observance.  - A remote data receiving device (6) cooperating with the data acquisition and processing unit (3) of the device for monitoring the compliance.
12. Installation selon la revendication 1 1 , caractérisée en ce que le dispositif de réception de données distant (6) comprend un serveur. 12. Installation according to claim 1 1, characterized in that the remote data receiving device (6) comprises a server.
PCT/FR2014/050115 2013-01-24 2014-01-22 Device for monitoring the observance of a home oxygen therapy treatment WO2014114875A1 (en)

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CN105050645A (en) 2015-11-11
AU2014208996A1 (en) 2015-09-10

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