FR2970652A1 - OSA PROCESSING DEVICE WITH ROUND DETECTION - Google Patents

Abstract

A device for monitoring an OSA treatment and for detecting snoring in a patient, comprising a gas passage (1) comprising an inlet (1a) and an outlet (1b), a flow rate determining device (2) ), connected to the passage (1), adapted to and designed to determine a flow value (Q) of the gas flowing between the inlet (la) and the outlet (1b) of said passage (1), a first absolute pressure sensor (3) connected at the inlet (1a) of the passage (1) to determine a first pressure value (P1), a second absolute pressure sensor (4) connected at the outlet (1b) of the passage (1 ) for determining a second pressure value (P2), information processing means (6) adapted to and adapted to process the flow (Q) and pressure (P1, P2) values and derive the occurrence therefrom of presence or absence of snoring in the patient and data storage means (5) adapted to and designed to memorize at least the s flow (Q), first pressure (P1) and second pressure (P2) values measured by, respectively, the flow determination device (2), the first pressure sensor (3) and the second pressure sensor (4).

Description

An autonomous device for monitoring a treatment of OSA further comprising means for detecting snoring emitted by a patient undergoing treatment for obstructive sleep apnea (OSA). Obstructive sleep apnea syndrome (OSA) is a widespread disorder affecting millions of adults, characterized by upper airway obstruction, which can cause snoring or breathing stops during sleep. Conventional OSA treatment involves applying positive air pressure to the patient's airways. The air pressure acts as an "air cushion" that keeps the upper airways open and prevents apnea. For this purpose, a device of the CPAP (Continuous Positive Airway Pressure) type or CPAP type is used which delivers slightly pressurized air to the patient's airways via a flexible pipe called patient circuit, connected to a respiratory mask, usually a nasal mask.

However, treatment with CPAP is very effective if its application is well followed but its effects are negligible, or even nil, if the patient does not observe his treatment for at least 4 hours / night. Knowing the patient's compliance, ie measuring the actual time during which they are following their treatment is therefore essential. Similarly, knowing in real time the effectiveness of treatment is a valuable aid to adjust the prescription treatment by the attending physician. Current compliance and efficacy systems are generally integrated with OSA treatment machines and results are known only in deferred time, typically between 1 and 3 months after passage to the patient's home. a treatment tracker who retrieves the data stored on a memory card or via a communication with a computer. We understand that this delay is not ideal if we want to obtain a real-time or near-real-time follow-up of the patient, so that we can react quickly if we realize that the patient is not following his or her treatment, and / or that the treatment is not suitable.

In addition, current processing machines often have an integrated compliance function but totally specific to each machine, which is not practical. In addition, the format of the compliance report is also specific and it is not always easy to interpret compliance data from one machine to another.

Moreover, being able to detect the snoring of patients with SORS is also essential because they are the sign of a collapse of the upper airways despite the treatment. The detection of snoring with the detection of respiratory events (apnea, hypopneas and flow limitation) make it possible to evaluate the effectiveness or not of the treatment. The problem to be solved is therefore to propose an autonomous device for monitoring or observing a sleep apnea treatment that can provide an analysis of the collected data that is useful to the physician, in particular respiratory frequency data, throughput rate. inspired and exhaled air, pressure supplied to the patient, apnea or hypopnea phases, and may further detect any snoring phases. The solution of the invention is a device for monitoring or observing a treatment of the AOS with detection of the snoring of the patient, comprising: a gas passage comprising an inlet and an outlet, for example a gas conduit; a flow-rate determination device, connected to the passage, adapted to and designed to determine a flow rate value Q of the gas flowing between the inlet and the outlet of said passage, a first absolute pressure sensor connected at the level of the entering the passage to determine a first pressure value P1; - a second absolute pressure sensor connected at the outlet of the passage to determine a second pressure value P2; - information processing means adapted to and designed to process the values; of flow rate Q and pressures P1, P2 and deduce therefrom a presence or absence of snoring information in the patient and - data storage means adapted to and designed to memorize at least the values of flow rate Q, first pressure P1 and second pressure P2 measured by, respectively, the flow rate determining device, the first pressure sensor and the second pressure sensor. Depending on the case, the device of the invention may comprise one or more of the following features: the flow-rate determination device is adapted to and designed to determine a volume flow value Q. The gas passage, the flow rate determining device, the first absolute pressure sensor and the second absolute pressure sensor are included in a single housing, that is to say a common shell or cowling. - The data storage means and / or the information processing means are included in the single housing or are located at a distance from said single housing. The single box further comprises transmission means adapted to and designed to transmit data or information. the information processing means comprise at least one microcontroller and an algorithm, and / or the storage means comprise at least one memory chip or a memory card. - The data storage means comprise at least one memory chip or a memory card, preferably pluggable, for example an SD card or the like. the transmission means comprise a wireless transmitter system, in particular of radiofrequency, bluetooth, Zigbee, wifi, GSM or GPRS type, and an antenna making it possible to provide a wireless transmission of data adapted to the type of transmitter and inserted in The box. - The radiofrequency transmitter system comprises a GSM or GPRS modem integrated or external to the common housing. the processing means, such as an on-board processor, are adapted to and designed to process the flow and pressure values determined by said flow rate determination device and said sensors and to preferentially deduce therefrom at least one datum of daily processing time and data of effectiveness of treatment of the OSA, for example the index of apnea / hypopnea, the index of respiratory disorders or Respiratory Disturbance Index (RDI), the average treatment pressure, the average flow ... - the processing means are furthermore capable of and designed to determine, by means of an algorithm, the presence of snoring. it furthermore comprises power supply means electrically connected to the flow rate determination device, pressure sensors, data storage means and / or transmission means. the power supply means comprise a power supply with a voltage of less than 50 V, for example a battery, a rechargeable battery, a mains power supply with a current transformer, typically at a voltage of between 2 and 25 V. The processing means algorithm is adapted to and capable of detecting patient respiration and minimum process pressure by processing flow and pressure signals measured by said flow rate determining device and said one or more pressure sensors. it further comprises one or more indicators, such as colored LEDs, for example red and green, providing the user with information relating to the effectiveness of the treatment applied by means of the device. According to another aspect, the invention also relates to a device for treating the AOS comprising a ventilation machine fluidly connected to the inlet of a device according to the invention, so as to supply said device with pressurized gas, preferably the output of the device according to the invention is connected in turn to a breathing mask or the like, via flexible gas conduits or the like.

According to yet another aspect, the invention also relates to a method for detecting the snoring of a patient following a treatment of the OSA, wherein: a) a first and a second pressure sensor is determined by means of absolute and a flow sensor of the pressure values P1, P2 and flow rate Q of the gas flowing between the inlet and the outlet of the gas passage of a device according to the invention fluidly connected to a treatment device of the (B) the flow and pressure values measured in step a) are treated by means of treatment means; c) the beginning and the end of each inspiratory phase of the patient are determined from 10 to 10 minutes; minus a flow rate value Q measured in step a), d) a snoring occurrence is detected during at least a part of at least one inspiration phase determined in step c) and from the one or more measured pressure values P1, P2) in step a), e) stored in storage means at least one of the 15 values measured in step a), f) transmitting, via transmission means, at least one of the values measured in step a). The invention will be better understood from the following description given in reference to the appended figures, in which: FIG. 1 is a block diagram of an embodiment of a tracking or observance device of FIG. A treatment of the AOS with snoring detection of the patient according to the present invention, - Figure 2 is a diagram of the communication principle of the device of Figure 1 according to the invention, - Figure 3 represents a block diagram illustrating the principle a calculation algorithm applicable in the context of the present invention to determine the occurrence or not of snoring in the patient, and - Figure 4 represents an algorithm for calculating compliance data. As illustrated in FIGS. 1 and 2, a device 10 for monitoring or observing a treatment of the AOS with snoring detection of the patient according to the present invention is formed of a housing 11 which is connected to the path respiratory gas, typically pressurized air, i.e., on the patient circuit 22 usually formed of one or more flexible lines and connecting an AOS processing machine 20, such as a machine of the type CPAP or BiPAP, respiratory mask 21, generally nasal, equipping a patient 30 to be treated. The connection of the device 10 to the patient circuit 22 is made by means of flexible tubes with conventional tips, for example ferrules of diameter equal to 22 mm and conforming to the ISO 5356-1 standard.

More specifically, as shown diagrammatically in FIG. 1, the device 10 comprises a housing 11 with an internal gas passage 1, such as a duct, with an inlet 1a and an outlet 1b within which the gas discharged by the treatment apparatus passes through. the OSA, before being sent to the patient. The gas flows from the inlet to the outlet lb.

A flow rate determination device 2, commonly called a "flow sensor", is arranged in the housing 11 and is connected to the passage 1 so as to allow a measurement of the flow rate Q of the gas flowing inside the passage 1 between the entry la and exit lb. The flow rate determination device 2 may be a hot wire flow meter or a depressed flow meter for example.

Furthermore, a first and a second absolute pressure sensor 3, 4 are also arranged on this passage 1 so as to allow a determination of the pressure inside the passage 1 of the housing 11 at the inlet 1a and of the output lb, respectively. The pressure sensors 3, 4 may for example be SCP sensors 1000 marketed by the company VTI. Advantageously, the first sensor 3 and the second absolute pressure sensor 4 are sampled at a frequency of 25 Hz, that is, a measurement is taken every 1 / 25th of a second. The pressure tap of the first absolute pressure sensor 3 is connected to the level of the inlet 1a of the passage 1, that is to say at the level of the connection with the duct 22 bringing the air under pressure from the machine 20 , and makes it possible to determine, that is to say, measure, at least a first pressure value P1, while the pressure tap of the second absolute pressure sensor 4 is connected at the output 1b of the passage 1 , that is to say at the level of the connection with the duct 22 bringing the pressurized air to the patient 30 (thus after passing through the casing 11), and makes it possible to determine therein, that is, to measure, at least a second pressure value P2. Said flow sensors 2 (ie the flow rate determination device) and pressure sensors 3, 4 are furthermore connected to processing means 6, such as an algorithm microcontroller, for example the Texas Instruments C1110 microcontroller. , capable of processing the pressure and flow rate measurements delivered by the pressure and flow sensors, in order to deduce the daily treatment duration and the effectiveness of the treatment of the patient's AOS P. Data storage means 5 are used to store all or part of the data thus measured and / or processed by the processing means 6, for example a data storage memory chip or a plug-in memory card, in particular an 8 GB SST flash memory card. Furthermore, transmission means 7, such as an RF radiofrequency type transmitter and an associated antenna or a GSM / GPRS type modem, are provided in the device 11 to enable transmission, preferably via a wireless transmission, of any or part of said data to a remotely located receiver, such as a computer 24 or server 23, as shown in Figure 2. The radio frequency transmitter or the like may be equipped with, for example, an 870 MHz PHYCOMP antenna.

Power supply means electrically connected to the various elements or components of the device of the invention provide their power supply, for example a low voltage power supply comprising one or more batteries, batteries ... The device according to the present invention allows to measure, independently of the AOS processing machine used and therefore without using information or data internal to this device, and remotely communicate, wirelessly, the information relating not only to the observance and the effectiveness of a treatment by CPP, ie the effective duration of treatment of the patients, but also the possible presence of phases of snoring in the patient thus treated ...

This allows, on the one hand, to obtain a daily follow-up and a security in the follow-up of the treatment of the patient at home thanks to the possibility of alarming the patient and his center of care in the event of non-monitoring of the prescription and, on the other hand, to evaluate the effectiveness of the treatment and to alarm the patient and his / her care center if the treatment is not effective enough.

The device of the invention has a recording capacity of several months, preferably at least 1 year, which can be further extended. It can communicate the data recorded by radio frequency RF, for example at a transmission frequency of 868 MHz or 2.4 GHz, to a computer, a PDA, a server or any other means capable of directly recording the transmitted data, as shown schematically in Figure 2. In fact, the device transmits remotely using the RF device or integrated GSM or GPRS modem that sends the data records of compliance and effectiveness of treatment of the patient to the care center for example, where a server 23 suitable for generating reports of compliance and treatment efficiency. Figure 3 represents a block diagram illustrating the principle of a calculation algorithm applicable in the context of the present invention to determine the occurrence or not of snoring in the patient. The process of data processing for the detection of snoring is done in 4 main steps, namely: - step 1: determination and storage / historization of the values Pl, P2 and Q; step 2: determination of the state of operation of the OSA machine from the values of P1 and Q; step 3: determining the beginning and the end of the inspiratory phase from the value of Q; and - step 4: actual determination of snoring during the inspiration phase from P2. During step 1, after determination of the absolute pressures P1, P2 by the pressure sensors 2, 3 and the volume flow rate Q by the flow sensor 4, the measured values (ie signals) are stored and historized, as such. and / or in groups of the n last values (with n> 2), within the data storage means 5. During step 2, the values of the first pressure P1 and the volume flow Q are used to determine whether the patient it is well-processed, that is, to determine whether the AOS processor 20 is supplying the device 10 and the mask 21 with pressurized gas, i.e., air at a pressure of 30.degree. order of 4 to 25 mbar. To do this, it is determined: - if the value of the first pressure P1 measured at the input la is such that: P1> Ep where Ep is a given threshold pressure value, for example Ep = 3 - and if the standard deviation of flow rate is such that: 6 (Q)> Gmin where Gmin is a value of the standard deviation of the given threshold flow rate, for example Gmin = 3 If both conditions are fulfilled, then the patient is considered to be following his treatment well as this means that not only the apparatus 20 delivers pressurized air but also that the patient inhales this air. Then, during step 3, the volume flow value Q is used to detect the start and end times of the patient's inspiratory phases. To do this, the flow rate signal Q is analyzed in the following manner: - the average flow rate Qmoy is first estimated from the flow data history stored in step 1. - then, if at a given moment to, the rate Q is such that: Q (to)> Qmoy + E; and if and at the instant of time, the rate Q is such that: Q (to -dt) <Qmoy + E; where it is a margin to avoid detecting measurement noise like breaths, then the moment to is considered to be the beginning of the patient's inspiration. then, the inspired air volume V (t) is estimated by integrating the flow integral for a given duration, measured from the instant to, ie: V (t) = f Q.dt 30 The end of inspiration is then defined as the moment ti between to and tz, for which V (t) is maximal; tz being the start time of the patient's next inspiration. Finally, during step 4, the pressure signal or signals P2 are isolated during all or part of the inspiration phase (s) between the times t 0 and t i estimated above, and the standard deviation G is measured. this standard deviation is greater than a given ET_lim value, ie 6> ET_lim, then it means that the pressure signal is disturbed by the snoring of the patient. It follows that the patient has snored during this phase of inspiration.

When such snoring is detected, then it is reported for the current minute. Every fifteen minutes, one records with the other data of use of the treatment and efficiency of the treatment during which minute (s) a snoring was reported. Moreover, the device of the invention can also measure the patient's treatment time and its efficiency when it is treated, and this, using the pressure measurements P1, P2 and flow Q operated in the passage of gas 1 of the device of the invention. The effectiveness of the treatment is then deduced from the variations in pressure and flow rate related to the inspirations / expirations of the patient and the level of treatment pressure, taking into account the number and / or the snoring time occurring during the treatment as determined. above. As an example shown in Figure 4, to calculate the duration of treatment follow-up by a given patient, the time can be divided into periods of a fixed duration that is called T, typically periods of 1 minute per minute. example. For each of these periods T, a second algorithm, also integrated in the processing means 6, determines whether during this period T the patient follows his treatment and if so, he counts the number of periods during which the patient has followed his treatment and calculates the duration of treatment follow-up. From the measurements of pressure P1 and / or P2 and flow Q, the second algorithm verifies over a given period, two conditions (condition P and condition Q) which are necessary and sufficient to determine whether during this period the treatment was followed, know: - a condition on the pressure: conditionP. If the average pressure P in the patient circuit is sufficiently elevated relative to the atmospheric pressure Patm, then the patient circuit is connected to the ORS treatment apparatus and the latter operates, i.e. it delivers a positive pressure of at least 4 cm H2O, thus greater than a minimum pressure value prefixed P.limite. - a condition on the flow: conditionQ. If the standard deviation of the flow rate signal E.T.Q exceeds a certain set threshold E.T.limit, then the flow measurements vary with an amplitude that can only be due to the breathing of the patient in the mask.

According to the results of the calculation of conditionP and conditionQ, it is deduced whether the treatment has taken place or not during the time period T considered and, if so, the duration of treatment Dt which corresponds to the number N of treatment periods multiplied by the duration of the period T. The device of the invention allows an observance and an effective follow-up of the patients 35 by detecting and taking into account the snoring of the patients. The automatic delivery of the results of observance and effectiveness of the treatment is carried out daily and without moving of a speaker since everything is done at a distance.

The device of the invention is used in the context of any method of therapeutic treatment of obstructive sleep apnea syndrome (OSA) of a patient characterized in particular by an obstruction of his upper airways.

Claims (11)

REVENDICATIONS1. A device for monitoring an OSA treatment and for detecting snoring in a patient, comprising: - a passage (1) of gas comprising an inlet (1a) and an outlet (1b), - a device for determining flow rate (2), connected to the passage (1), adapted for and designed to determine a flow value (Q) of the gas flowing between the inlet (la) and the outlet (1b) of said passage (1), - a first sensor of absolute pressure (3) connected at the inlet (1a) of the passage (1) to determine a first pressure value (P1), - a second absolute pressure sensor (4) connected at the outlet (1b). ) of the passage (1) to determine a second pressure value (P2), - information processing means (6) adapted to and designed to process the values of flow (Q) and pressures (P1, P2) and derive the occurrence of a presence or absence of snoring information from the patient and - data storage means (5) adapted and adapted for at least the flow rate (Q), first pressure (P1) and second pressure (P2) values measured by, respectively, the flow rate determining device (2), the first pressure sensor (3) and the second pressure sensor (4). 20 2. Tracking device according to claim 1, characterized in that at least the gas passage (1), the flow rate determining device (2), the first absolute pressure sensor (3) and the second pressure sensor. absolute (4) are included in a single housing (10). 3. Tracking device according to one of the preceding claims, characterized in that the data storage means (5) or the information processing means (6) are included in the single housing (10) or are located in distance from said single housing (10). 4. Tracking device according to one of the preceding claims, characterized in that the single housing (10) further comprises transmitting means (7) adapted to and designed to transmit data or information. 35 5. Tracking device according to one of the preceding claims, characterized in that the information processing means (6) comprise at least one microcontroller and an algorithm, or the storage means (5) comprise at least one memory chip or a memory card. 25 30 6. Tracking device according to claim 4, characterized in that the transmitting means (7) comprises a wireless transmitter system and an antenna for ensuring a wireless transmission of data or information. 7. Tracking device according to one of the preceding claims, characterized in that the information processing means (6) are adapted to and designed to process the flow rate and pressure values determined by the flow rate determination device ( 2) and said one or more absolute pressure sensors (3, 4) and deriving therefrom at least one daily treatment time data and at least one AOS processing efficiency data, 8. Tracking device according to one of the preceding claims, characterized in that the algorithm of the processing means (6) is adapted to and designed to operate: - a determination and storage of pressure values (P1, P2) and flow rate (Q) measured by the pressure (3, 4) and flow (2) sensors, - a determination of the beginning and end of each inspiratory phase of the patient from the measured flow rate (Q) value and - detecting the occurrence of snoring during an inspiration phase from the measured pressure value (s) (P1, P2). 9. Tracking device according to claim 8, characterized in that the algorithm of the processing means (6) is adapted to and designed to operate, in addition, a determination of gas flow in the passage (1) from the pressure value (P1) measured by the first sensor (3) and volume flow (Q). 10. Tracking device according to one of the preceding claims, characterized in that the first absolute pressure sensor (3) and the second absolute pressure sensor (4) are sampled at a frequency of 25 Hz. 11. Apparatus for processing the AOS comprising a ventilation machine (M) fluidly connected to the inlet (la) of a device according to one of the preceding claims, so as to supply said device with pressurized gas.