FR3006881A1 - FACILITATION FOR MONITORING THE OBSERVANCE OF A HOME OXYGEN THERAPY TREATMENT WITH SENSORS AT THE NASAL CANAL LEVEL - Google Patents

Abstract

The invention relates to an installation for monitoring the compliance of a patient with oxygen therapy (20) comprising a nasal cannula (1), a measurement and data transmission unit (2, 19) arranged on or in proximity to the nasal cannula (1) having one or more sensors selected from a pressure sensor, a temperature sensor and a CO2 or O2 concentration sensor, a capacitive sensor and an accelerometer adapted to and designed to obtain raw data for measurement of pressure, temperature and / or concentration of CO2 or O2, capacitive measurement and / or acceleration measurement and first data transmission means (19) adapted and adapted for transmitting any or part of the raw measurement data measured by the one or more sensors, and a remote acquisition box (4) comprising first data receiving means (5, 16) adapted to and designed to receive all or part of the data of raw measurement transmitted by the first data transmission means (19), and data processing means (6, 9) comprising a microprocessor (9) implementing an analysis algorithm (6) adapted to and designed to process said raw data to obtain processed measurement data.

Description

The invention relates to an installation for monitoring a home oxygen treatment comprising a measurement and data transmission unit arranged on or near the nasal cannula, which is equipped with one or more sensors and means for data transmission and cooperates with a remote acquisition box. Oxygen therapy is a treatment consisting in administering to a patient in need, an oxygen-rich gas, for example pure oxygen or a 02 / 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 Disease (COPD), and thus to improve their quality and life expectancy.

The treatment with oxygen therapy is generally carried out 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. 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. 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.

However, existing monitoring devices have a number of problems and disadvantages. Some of these devices have a mode of operation based on measurement at a single point, that is, near the gas source or in the middle of the gas supply line connecting the oxygen source to the patient. , of various physical magnitudes, mainly pressure.

In this case, the signal coming from the source of oxygen-rich gas (ie the gas flow) and the signal coming from the patient (ie breathing) are often difficult to separate, which makes it necessary to work on reduced operating ranges. and leads to severe measurement inaccuracies or uncertainties. Thus, the patient may sometimes 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 unrelated to the delivery system. breathing gas. 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 gas supply line from the oxygen source. 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.

However, double lumen cannulas are expensive, so less used than simple cannulas. In addition, in some cases, it is not possible to adapt the cannulas to the patient's need. The treatment is then less effective and / or the patient does not adhere to his treatment. 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 does not work because the second conduit is not connected to the on-board pressure sensor and the device no longer detects the patient's breathing. In addition, current devices 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. The problem then is to propose a facility for monitoring an improved home oxygen therapy. The solution is a facility for monitoring the compliance of a patient with oxygen therapy treatment comprising: a nasal cannula for feeding a patient's nostrils with an oxygen-rich gas, a unit of measurement and for transmitting data arranged on or near the nasal cannula comprising: one or more sensors selected from a pressure sensor, a temperature sensor and a CO2 or O2 concentration sensor, a capacitive sensor and an accelerometer adapted to and designed to obtain raw pressure, temperature measurement data and / or CO2 or O2 concentration, capacitive measurement, acceleration measurement and. first data transmission means adapted to and adapted to transmit all or part of the raw measurement data measured by the one or more sensors, and - a remote acquisition box comprising: first data receiving means adapted to and adapted to receive all or part of the raw measurement data transmitted by the first data transmission means, and. data processing means comprising a microprocessor implementing an analysis algorithm adapted to and designed to process said raw data to obtain processed measurement data. Depending on the case, the installation of the invention may comprise one or more of the following technical characteristics: the unit of measurement and data transmission comprises several sensors. the acquisition box comprises second data transmission means adapted to and designed to transmit all or part of the raw measurement data and / or measurement data processed by the analysis algorithm, to at least one data transmission device; remote data reception. the first data transmission means and / or the second data transmission means comprise a radiofrequency or GPRS antenna. the acquisition box comprises a data storage memory and a source of electrical energy, for example a battery. the sensor (s) for pressure, temperature and / or concentration of CO2 or O2, of capacitive measurement or of acceleration are suitable for and designed to obtain raw data for measuring pressure, temperature, CO2 concentration or 02, capacitive, and / or acceleration and to convert them into corresponding electrical signals, namely pressure signals, temperature, CO2 concentration or O2, capacitive measurement, measurement and / or acceleration, respectively. - The unit of measurement and data transmission comprises a microprocessor cooperating with the sensor or sensors and / or the first data transmission means. the remote data reception device comprises a server. The data retrieved at the server level can be used to be made available to a medical monitoring provider or a doctor. - The nasal cannula is fluidly connected to at least one flexible conduit connected to a gas supply line fed by a gas source, in particular an oxygen source or a gas rich in oxygen. - The unit of measurement and data transmission is arranged on the nasal cannula or on a flexible conduit near the nasal cannula. the measurement and data transmission unit is supplied with electric power by a miniature battery, one or more electrical wires or means of energy recovery. - The acquisition box comprises an internal gas passage and connecting means for fluidically connecting said internal passage to a gas supply line connecting a gas source to the cannula. The present invention will now be better understood thanks to the following explanations given with reference to the appended figures in which: FIG. 1 represents a schematic view of an embodiment of a facility for monitoring the observance of a treatment of oxygen therapy according to the present invention with a case of acquisition carried by the patient; - Figure 2 shows a first embodiment of a nasal cannula equipped with gas supply ducts likely to equip the installation of Figure 1; - Figure 3 shows a schematic view of the main components of the acquisition box of the installation of Figure 1; and - Figure 2 shows a second embodiment of a nasal cannula likely to equip the installation of Figure 1; FIG. 1 schematizes an embodiment of an installation for monitoring the observance of an oxygen therapy treatment 4 according to the invention comprising a nasal cannula 1 equipped with one or more sensors, a remote acquisition case 4 , for example worn by a patient 20, and other components as detailed below. According to the invention, a patient 20 is equipped with a nasal cannula 1, as illustrated in FIGS. 1 and 2, which nasal cannula 1 makes it possible to feed the nostrils of the patient 20 with an oxygen-rich gas, via two expansions or nostrils to be positioned within the nostrils of the patient 20 to distribute the oxygen-rich gas (> 21% vol. More specifically, the nasal cannula 1 is hollow and is supplied with gas through a (or) flexible conduit 12, 13 to which is connected a gas supply line 10 fluidly connecting a source 14 of oxygen-rich gas, such as a bottle of oxygen, an oxygen concentrator or the like, to the nasal cannula 1. As shown in FIGS. 1, 2 and 4, the gas supply line 10 branched (at 11) into two flexible ducts 12, 13 each to be connected to the nasal cannula 1 to bring the oxygen-rich gas to the cannula 1. However, it is also possible to use a cannula 1 fed by a single supply conduit 12, 13. According to the invention, it is possible to a unit of measurement and data transmission 2 on or at the level, that is to say, in the immediate vicinity, of the nasal cannula 1.

Thus, the unit 2 can be arranged directly on the cannula 1, as illustrated in the second embodiment of FIG. 4, or else on a flexible conduit 12, 13 near said cannula 1 so as to carry out the desired measurements. at or in the immediate vicinity of the nasal cannula 1, therefore closer to the patient 20, as illustrated in the first embodiment of Figure 1.

The measurement and data transmission unit 2 comprises at least one and preferably a combination of several sensors selected from pressure, temperature, CO2 concentration and / or O 2 and / or capacitive measurement sensors and / or or acceleration. The pressure, temperature, CO2 or O2 content and / or capacitive measurement and / or acceleration measurements made by the sensors of this unit 2 make it possible in particular to detect the patient's breathing and / or physical activity and / or or the presence of the cannula on the patient even if it breathes through the mouth, and / or the oxygen content of the inhaled gas. Once measured, this information or raw data (pressure, temperature, concentration of CO2 or 02 , acceleration, capacitive measurement) are converted into electrical signals, then transmitted by data transmission means 19, namely a first data transmission system, preferably integrated in the unit 2, as illustrated in FIG. 2 , which is adapted to and designed to transmit all or part of the raw measurement data measured by the one or more sensors. This first raw data transmission system 19 of the unit 2 comprises for example a microprocessor, for example a microprocessor of the ultra-low consumption type, and a radiofrequency antenna capable of transmitting in the ISM frequency bands ("Industrial Scientific and Medical ") falling between 800 MHz and 5 GHz, or capable of retro-modulating an ultra-high frequency magnetic or electromagnetic wave, that is to say between 300 MHz and 3 GHz, and in particular of 900 MHz order.

The energy required for the measurement and transmission of the raw data by the measurement and data transmission unit 2, 19 can be provided by a miniature battery or via electrical wires integrated directly into the cannula 1 and connected to a cable. energy source. However, it is preferable to provide an energy recovery unit which may be a mechanical energy recovery unit, for example via a transducer which transforms the vibratory energy of a microbeam into an electric current, or a recovery unit of energy. radiation energy, for example via a transducer which converts the RF wave energy into an electric current. It is also possible to use a combination of two or more of these means for supplying electrical energy. The raw data transmitted by the first raw data transmission system 19 of the measurement and data transmission unit 2 are received and processed by first data receiving means 5 within an acquisition unit 4 and data processing unit located at a distance from the nasal cannula 1. The data acquisition and processing unit 4 comprises a box that can for example be worn by the patient, as shown in FIG. 1. The first reception means data 5 comprise for example a receiving antenna 16 of the printed type or on an electronic card or connected to an electronic card. Within the data acquisition and processing unit 4, also called an acquisition box, an analysis algorithm 6 makes it possible to collect the raw measurement data transmitted by the data transmission system of the unit 2 and received by the first data receiving means 5, and processing them to obtain processed measurement data, which are then transmitted by a second data transmission system 7. A microprocessor 9 makes it possible to operate the analysis algorithm 6, for example a microprocessor 9 of the digital signal processor type. It is also possible to provide a recording of the data in the acquisition box 4, before transmission to a remote server 8 or the like, on a memory chip 15 for recording all or part of the raw and / or processed data, as illustrated in FIG. FIG. 3. The second data transmission system 7 is therefore adapted to and designed to transmit the raw measurement data and / or measurement data processed by the analysis algorithm 6 to at least one reception device 8. remote data, such as a remote server where they can be processed, stored, etc ... In this second data transmission system 7, the data transmission is done for example on the GPRS mode, or radio frequency in the ISM frequency bands between 800 MHz and 5 GHz, or by writing data to an SD card which can then be read on a computer, or by wired connection to a computer, for example of the USB or RS232 type or by a system capable of automatically transmitting the data to a remote data receiving device 8, such as a remote server. The transmission of data by the second data transmission system 7 to the server 8 or the like is for example via a transmitting antenna 17 of the type soldered on an electronic card or connected to an electronic card.

According to the invention, one thus implements one or more sensors as discrete as possible, arranged directly on the cannula 1 within the unit 2 and communicating with the acquisition box 4. Note that the box 4 can be is completely remote and away from the patient, for example arranged on or at the source of gas 14, is worn by the patient. Moreover, the housing 4 is supplied with energy by an electric source 18, for example a rechargeable battery or not for the case in particular where the housing 4 is carried by the patient 20 (see FIG 1), or simply via a socket power supply connected to the sector when the housing is completely remote from the patient, or by induction.

The electrical source 18 supplies electrical power to the various components of the acquisition box 4, which requires energy to operate, in particular the microprocessor 9, the storage memory 15, the first reception means 5 and the second transmitter means 7. As illustrated in Figures 1, the housing 4 may also contain one or more pressure sensors and / or flow and / or acceleration. In the case of pressure and / or flow sensors, the housing 4 comprises an internal conduit 11 passing therethrough, and pneumatic connectors compatible with the oxygen tubes and cannulas at each end so as to be able to come and connect to the d-line. supply of gas 10. The flow of oxygen from the gas source 14 thus passes through the housing 4 via this internal conduit 14.

The unit of measurement and data transmission 2 is either disposable in the same way as the cannula 1, or disinfectable, that is to say, sterilizable, and therefore reusable. In both cases, it can be mounted on any cannula 1. If it is disinfectable and / or sterilizable, it must be dismountable and protected by a gel or a membrane, Gore-TexTM for example, supporting the disinfection without disturbing the measurement.

The measurement unit 2 is for example equipped with a needle or the like enabling it to pierce the cannula 1 so that the sensor (s) can (s) perform measurements of the characteristics of the gas inside the cannula 1. The measuring unit 2 is furthermore for example equipped with one (or more) ring or any other fastening means enabling it to be attached to and possibly detached from the cannula 1 or a conduit 12, 13 supplying said cannula 1. Preferably, the ring or the like is covered with a material that is comfortable for the patient 20. In summary, in operation, the information or data of the pressure, temperature, CO2 content or 02 type, capacity and / or acceleration are measured by the sensor or sensors of the unit 2 arranged directly on the cannula 1 or one of the pipes 12, 13 supplying the patient 20 with oxygen from the oxygen source 14 which can be fixed , as an oxygen concentrator, is mobile, such the an ambulatory oxygen bottle.

The data thus collected in the unit 2 are then transmitted to the acquisition unit 4 acting as a data acquisition and processing unit. The acquisition box 4 is arranged at a distance from the cannula 1. Thus, as already explained, it can be arranged on the flexible conduit 10 conveying the oxygen-rich gas, such as pure oxygen, from the oxygen source. 14 to the nasal cannula 1 feeding the nasal airways of the patient 20, or where appropriate on the gas source 14 itself. In some embodiments, the acquisition box 4 may itself measure pressure and / or flow and / or acceleration data (Fig. 3). After acquisition and / or reception of the raw data, they are stored in raw form in a storage memory 15 of the acquisition box 4 and / or processed by means of the analysis algorithm 6 implemented. by the microprocessor 9 to obtain processed measurement data which can in turn be stored and / or issued by the second data transmission system 7 internal to the box 4, to a remote server 8 or the like. More precisely, the data of pressure, temperature and / or content of CO2 or O 2, of capacity and of acceleration measured on the measurement unit 2 and transmitted to the acquisition box 4 can be memorized over a buffer period, by example of at least 30 seconds, preferably 1 min or more. The stored data can be filtered to remove any disturbance due to the environment. The detection of the patient's respiration is deduced from the variation of at least one of these data during the buffer period. Then, a Fast Fourier Transform type algorithm can be implemented and applied to the stored data to derive the average and maximum respiratory rate. Furthermore, the housing 4 may also be accompanied by a cannula port sensor located on the cannula 1 which detects when the patient 20 carries his cannula. The acceleration data measured on the measurement unit 2 or in the case 4 are stored over a buffer period, for example 1 min. Activity level indicators are calculated from these data, for example the Magnitude Vector signal, and / or the Magnitude Area signal, and / or the mean, and / or the standard deviation, and / or the variance. These activity indicators are then compared to thresholds determined experimentally according to the levels of activity that must be detected: at rest, in activity, sitting, lying down ... The pressure and / or flow data measured in the case 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 8, in particular to a server or the like where they are stored and subsequently used to determine whether the patient observes his treatment well and if this treatment is effective.

The pressure signal measured by the unit 2 is all the more precise and exploitable as it is measured near the patient 20. From there, the fact that the signal is measured at the level of the nose, is that is to say at the level of the cannula 1, makes it possible to obtain a stronger patient signal than the signal when it is measured at the level of the gas source 14 or between the gas source 14 and the cannula 1.

In fact, the fact that the sensors are located close to the patient makes it possible to amplify the "patient" signal with respect to the signal at the source of gas 14, and thus facilitates their separation and the analysis that results therefrom. Indeed, it is the variations of the patient signal that are interesting and must be exploited to deduce the patient's breathing, periods of breathing by the mouth, the respiratory rate of the patient. Positioning itself just at the birth of this signal thus makes it possible to overcome the inconvenience caused by the gas source 14 that is generally observed when the sensor (s) is placed on the conduit 10 arriving at the cannula 1 halfway. path between the patient 20 and the gas source 14.

The installation of the invention can be used to follow an oxygen therapy treatment in a patient suffering from respiratory disorders, in particular of the COPD type.

Claims (12)

REVENDICATIONS1. Installation for monitoring the compliance of a patient with oxygen treatment (20) comprising: - a nasal cannula (1), - a measurement and data transmission unit (2, 19) arranged on or close to the nasal cannula (1) comprising:. one or more sensors selected from a pressure sensor, a temperature sensor and a CO2 or O2 concentration sensor, a capacitive sensor and an accelerometer adapted to and designed to obtain raw pressure, temperature measurement data and / or CO2 or O2 concentration, capacitive measurement and / or acceleration measurement and. first data transmission means (19) adapted and adapted to transmit all or part of the raw measurement data measured by the one or more sensors, and - a remote acquisition box (4) comprising: first data receiving means (5, 16) adapted and adapted to receive all or part of the raw measurement data transmitted by the first data transmission means (19), and. data processing means (6, 9) comprising a microprocessor (9) implementing an analysis algorithm (6) adapted to and designed to process said raw data to obtain processed measurement data. 2. Installation according to the preceding claim, characterized in that the measuring unit and data transmission (2, 19) comprises a plurality of sensors selected from a pressure sensor, a temperature sensor and a CO2 concentration sensor. 3. Installation according to one of the preceding claims, characterized in that the acquisition box (4) comprises second data transmission means (7, 17) adapted to and designed to transmit all or part of the raw measurement data. and / or measurement data processed by the analysis algorithm (6), to at least one remote data receiving device (8). 4. Installation according to one of the preceding claims, characterized in that the first data transmission means (19) and / or the second data transmission means (7, 17) comprise a radiofrequency antenna or GPRS. 5. Installation according to one of the preceding claims, characterized in that the acquisition box (4) comprises a data storage memory (15) and a power source (18). 6. Installation according to one of the preceding claims, characterized in that the or sensors of pressure, temperature, CO2 concentration and / or 02, capacitive measurement and / or acceleration measurement are suitable for and designed to obtain raw data for measurement of pressure, temperature, CO2 concentration and / or 02, capacitive measurement and / or acceleration measurement, and to convert them into corresponding electrical signals. 7. Installation according to one of the preceding claims, characterized in that the measurement and data transmission unit (2, 19) comprises a microprocessor cooperating with the sensor (s) and / or the first data transmission means ( 19). 8. Installation according to one of the preceding claims, characterized in that the remote data receiving device (8) comprises a server. 9. Installation according to one of the preceding claims, characterized in that the nasal cannula (1) is fluidly connected to at least one flexible conduit (12, 13) connected to a gas supply line (10) fed by a a source of gas (14), in particular a source of oxygen or a gas rich in oxygen. 10. Installation according to one of the preceding claims, characterized in that the unit of measurement and data transmission (2, 19) is arranged on the nasal cannula (1) or on a flexible conduit (12, 13) to near the nasal cannula (1). 11. Installation according to one of the preceding claims, characterized in that the unit of measurement and data transmission (2, 19) is supplied with electric current by a miniature battery, one or more electrical son or recovery means. energy. 12. Installation according to one of the preceding claims, characterized in that the acquisition housing (4) comprises an internal passage (11) of gas and connecting means for fluidically connecting said internal passage (11) to a line gas supply (10) connecting a source of gas (14) to the cannula (1).