Systems and methods for controlling a tracheobronchial air stimulator - Patents.com

Abstract

An automatic control system for a tracheobronchial pneumatic stimulator (10) intended to be connected to a subject, the stimulator (10) comprising: a pressure unit (13) configured to generate a set of negative pressure pulses during a relaxation exhalation of the subject, each pulse corresponding to an output of the pressure unit (13); and a connection assembly (11, 12) configured to connect the pressure unit (13) to the subject's respiratory system. The control system comprises: a pressure sensor (15) configured to measure an internal negative pressure (P) applied to the subject's respiratory system corresponding to each pulse after it is generated by the pressure unit (13); a calculation module (32) configured to compare in real time the absolute value of the measured internal negative pressure (P) with a predetermined threshold (S) and, based on the comparison result, determine an updated output value to be applied to the pressure unit (13) such that the absolute value of the subsequent internal negative pressure (P) corresponding to the updated output value is less than the absolute value of the threshold (S); and a control module (33) configured to apply the updated output value to the pressure unit (13) before the generation of the next pulse.

Description

[Technical Field]

[0001] The present invention relates to the field of tracheobronchial air stimulators, particularly for subjects with respiratory disorders. More particularly, the present invention relates to an automatic control system for a tracheobronchial air stimulator intended for connection to a subject, and a method for controlling a tracheobronchial air stimulator. The present invention has been found to be particularly advantageous, but not limited to, for subjects who are not regularly assisted by a competent operator or physician. [Background technology]

[0002] In healthy individuals, the lungs are covered with a membrane called mucus, several millimeters thick and of a highly fluid, normal viscosity. The function of this mucus is to protect lung cells by preventing them from direct contact with the air inhaled by the lungs. This mucus renewal is ensured by motile cilia located on the surface of the bronchi. These cilia beat (their movement is called oscillatory) toward the proximal airways, thus eliminating inhaled particles that slide over the ciliary layer and are trapped in the coagulated phase of the mucus. This kinetic dynamic, known as mucociliary clearance (i.e., the ability of a tissue, organ, or organism to remove a given substance from the fluid), occurs in the trachea at a rate of approximately 5 mm / min, ensuring renewal of the mucus layer approximately every 20 minutes. This mucociliary clearance allows the mucus to be expelled toward the pharynx, where it is either coughed up or swallowed.

[0003] Various pathologies result in obstructive respiratory diseases or obstructive pulmonary syndromes, characterized by the accumulation of mucus. Such accumulation of mucus results in restricted airflow and increased air resistance, particularly in the bronchial tree, which potentially contribute to the development of serious infections. Obstructive respiratory diseases can result from chronic diseases corresponding to bronchiectasis (also known as BD), which in most cases results from bronchial, pulmonary, or pleural diseases.

[0004] Bronchiectasis can be focal or diffuse and is characterized by dilation of small to medium-sized bronchi, often accompanied by abundant mucopurulent sputum, reflecting hyperinfection. There are several possible causes of bronchiectasis, including cystic fibrosis, COPD (e.g., emphysema or chronic bronchitis), severe childhood infections (e.g., asthma or bronchiolitis), ciliary dysfunction, bronchial stenosis, a consequence of pulmonary tuberculosis, or congenital or acquired Ig deficiency (A, G, or M).

[0005] To promote the circulation and discharge of mucus, different solutions have been used so far. For example, the use of mucolytics and mucomodulators is well known. However, such solutions are only partial and only allow to avoid excessive infection. Therefore, they are often supplemented by physical therapy sessions, which can be traumatic for the patient and may have limited effectiveness when the mucus is too viscous or elastic.

[0006] Other solutions exist using stimulation devices configured to stimulate air in the tracheobronchial tree of a subject. Such stimulation devices comprise a pressure unit configured to generate pressure pulses, either positive or negative (negative pressure pulses also known as "negative pressure"), and a connection means, such as a tube, configured to connect the pressure unit to the subject's respiratory system, preferably with a tip that is inserted into the subject's mouth. Within the framework of the present invention, the expression "subject's respiratory system" refers to the subject's airways, including tubes such as the pharynx, larynx and bronchi, as well as the lungs themselves.

[0007] The operation of such a stimulator involves the delivery of positive pressure pulses during the inhalation phase and negative pressure pulses during the exhalation phase. The purpose is to stimulate the subject to cough during the exhalation phase in order to separate the mucus from the bronchial walls. However, such a process is difficult to implement because, first, coughing can cause physical discomfort to the subject, especially if the mucus is not sufficiently elastic, and second, the amplitude of the pulses can cause lung collapse, which can have serious consequences for the subject's health.

[0008] More recently, it has been proposed to regulate the use of such stimulators by applying negative pressure during relaxation exhalation phases, alternating with phases of returning to ambient pressure (i.e., the subject inhaling after removing the connecting means from their mouth). Within the scope of the present invention, "relaxation exhalation" refers to exhalation supported by the stimulator via the negative pressure pulses. Such a process advantageously allows for avoiding coughing and lung collapse. However, the results obtained in terms of mucus removal efficiency are still not optimal. While coughing is indeed avoided, the operation of the stimulator implies a continuous increase in negative pressure applied to the subject's respiratory system during each relaxation exhalation. This increase is likely to cause discomfort to the patient and thus hinder optimal lung emptying. As a result, distal airways cannot be reached and the associated mucus cannot be removed. Summary of the Invention

[0009] It is an object of the present invention to overcome all or some of the limitations of prior art solutions by providing a system and method that allows a subject's exhalation time to be maximized during relaxation exhalation performed with a tracheobronchial pneumatic stimulator, in a manner that empties the subject's lungs as much as possible to increase the efficiency of stimulation (i.e., apply a greater tolerable negative pressure), while taking into account the subject's tolerance of negative pressure (i.e., avoiding coughing). Stimulation is enhanced by real-time control of negative pressure.

[0010] To this end, according to a first aspect, the subject of the present invention is an automatic control system for a tracheobronchial air stimulator intended to be connected to a subject, said stimulator comprising a pressure unit configured to generate a set of negative pressure pulses, each pulse corresponding to the output of the pressure unit, during a relaxation exhalation of the subject, and a connection assembly configured to connect the pressure unit to the respiratory system of the subject, said control system comprising: a pressure sensor configured to measure an internal negative pressure applied to the subject's respiratory system corresponding to each pulse after said pulse is generated by the pressure unit; a calculation module configured to compare the absolute value of the measured internal negative pressure with a predetermined threshold in real time and, based on the comparison result, determine an updated output value to be applied to the pressure unit such that the absolute value of the subsequent internal negative pressure corresponding to the updated output value is less than the absolute value of the threshold; a control module configured to apply the updated output value to the pressure unit before the generation of a next pulse; The system is provided with:

[0011] "Respiratory system of a subject" refers to the set of airways of a subject, including the pharynx, larynx, and ducts such as the bronchi, as well as the lungs themselves.

[0012] "Relaxed exhalation" refers to the expulsion of air from the subject's lungs using only the pulses, i.e., the subject is not exhaling voluntarily. Furthermore, "output" refers to the quantity representing the volume of air expelled for each negative pressure pulse. Therefore, an increase / decrease in such output corresponds to an increase / decrease in the volume of air expelled due to an increase / decrease in the output for negative pressure. In this context, an increase in negative pressure means an increase in the absolute value of the negative pressure; in other words, a lower pressure is applied to the subject when negative pressure increases.

[0013] "Internal negative pressure" refers to the pressure actually felt by the subject, i.e., the pressure inside the mouth at the entrance to the subject's airway. Typically, the value of the internal negative pressure ranges from -10 mbar to -100 mbar during operation of the device. The internal negative pressure may differ from the expected negative pressure pulse generated by the pressure unit depending on the control output value. In practice, a given output value of the pressure unit generates a theoretical negative pressure, typically ranging from -300 mbar at full output to 0 mbar at minimum output, but the actual negative pressure is affected by various characteristics, particularly the duct, the stage of exhalation, and the actual subject's anatomy. The internal negative pressure is an important parameter for automatic control systems.

[0014] "Real-time" means that the comparison of the absolute value of the measured internal negative pressure (during the current negative pressure pulse) with the threshold value is rapid enough to modify the command sent to the pressure unit for the next negative pressure pulse. At a negative pressure frequency of 12 Hz, the comparison must be made by the calculation module in less than 80 ms. At a negative pressure frequency of 6 Hz, the comparison must be made by the calculation module in less than 160 ms. The internal negative pressure may be measured at a sampling rate of 100 Hz for comparison and control of the pressure unit.

[0015] The system is therefore primarily based on measuring said internal negative pressure in real time, resulting in the actual negative pressure felt by the subject, which may be different from the negative pressure applied by the pressure unit. The calculation module uses this measured internal negative pressure, compares it to a threshold, and then determines an output value to ensure that the next negative pressure pulse remains below the threshold.

[0016] In this way, if the internal negative pressure associated with a pulse exceeds the threshold, this exceedance does not continue into at least the next pulse. This in turn prevents the internal negative pressure from being maintained above the threshold for too long, so that the relaxation exhalation is not prematurely terminated by the subject, for example, because the subject feels the need to cough. Finally, the relaxation exhalation is carried out for a period long enough that the subject completely empties their lungs of the air contained therein, which promotes the expulsion of mucus during the relaxation exhalation.

[0017] Furthermore, unless a threshold value is exceeded, such a system prevents the internal negative pressure from being maintained at too low a level for too long, which in turn prevents too small a volume of air from being removed from the subject's lungs, thus increasing the efficiency of mucus clearance during relaxed exhalation.

[0018] Finally, with this automatic control system, the negative pressure applied to the subject never exceeds a tolerance value below the threshold at which the subject begins to cough during the entire relaxation exhalation.

[0019] In particular embodiments, the system may further comprise one or more of the following features, chosen alone or according to any technically possible combination:

[0020] According to one embodiment, the system further comprises an acquisition module configured to acquire, during a relaxation exhalation of the subject and after each pulse is generated by the pressure unit, a value of the measured internal negative pressure associated with said pulse.

[0021] According to one embodiment, the calculation module is configured to determine whether the absolute value of the measured internal negative pressure exceeds the absolute value of a threshold value and, if so, to determine a reduced power value to be applied to the pressure unit, thus allowing the comparison to detect when the threshold value is exceeded, thereby ensuring that the calculation module generates an appropriate power value to optimize the operation of the stimulation device.

[0022] According to one embodiment, the calculation module is configured to determine the reduced output value as a function of the difference between the absolute value of the measured internal negative pressure and the absolute value of the threshold, such that the absolute value of the subsequent internal negative pressure corresponding to the reduced output value is reduced by a value between 10 mbar and 60 mbar compared to the last measured internal negative pressure. Selecting such a range advantageously reduces the internal negative pressure sufficiently so that the subject does not experience any respiratory discomfort and can therefore continue to use the stimulation device. In other words, the subject does not feel the need to remove the tip from their mouth, so that the lungs continue to empty, thereby enhancing air evacuation from the lungs. Targeting such a specific range also allows for fine control over the operation of the stimulation device.

[0023] According to one embodiment, the reduced output value is determined from among a set of predetermined output values, which allows for pre-programming of the reduced output values, thereby simplifying the electronic architecture of the system.

[0024] According to one embodiment, said predetermined value is substantially equal to a multiple of 1 / 10 of the maximum power output of the pressure unit. The selection of such a value makes it possible to obtain good efficiency while maintaining a simplified electronic architecture.

[0025] According to one embodiment, when several reduced output values ​​are determined by the calculation module during the subject's relaxation exhalation, the values ​​form a regular sequence over time. Such a configuration can prevent the subject from feeling rushed during relaxation exhalation because they always experience the same reduction in output. As a result, the subject has a smoother interaction with the stimulation device, thereby increasing comfort and resulting efficacy.

[0026] According to one embodiment, the calculation module is configured to determine whether the absolute value of the measured internal negative pressure exceeds the absolute value of the threshold value and, if not, to determine an increased power value to be applied to the pressure unit, thus making it possible to detect that the threshold value has not been reached in this case, thereby ensuring that the control module generates appropriate commands to optimize the operation of the stimulation device.

[0027] According to one embodiment, the calculation module is configured to determine the increased power value as a function of the difference between the absolute value of the measured internal negative pressure and the absolute value of the threshold, so that the subsequent internal negative pressure corresponding to the increased power value is increased by a value between 10 mbar and 60 mbar compared to the last measured internal negative pressure. Selecting such a range advantageously prevents the stimulation device from operating at a power rate that is too low, such that not enough air is expelled from the lungs with each pulse. In other words, proceeding in this manner increases the performance and efficiency of the device by expelling an optimal volume of air during each relaxation exhalation until the threshold is reached.

[0028] According to one embodiment, the pressure unit is configured to associate a first set of consecutive exhalations with pulses generated by the pressure unit at a first frequency, and to associate a second set of consecutive exhalations with pulses generated by the pressure unit at a second frequency different from the first frequency, for a plurality of relaxation exhalations of the subject.

[0029] According to one embodiment, the first frequency is equal to 12 Hz and the second frequency is equal to 6 Hz, which frequencies increase the liquefaction and expulsion power of mucus, respectively.

[0030] According to one embodiment, the threshold value corresponds to a balance between performance (i.e., optimal evacuation of air from the lungs) and comfort limits determined by the subject while using the stimulation device. Such a configuration allows for better respect of the subject's tolerance for the operation of the stimulation device, thus promoting long-term use of the device and therefore optimal efficiency.

[0031] According to one embodiment, the threshold is a predetermined value determined during a testing phase of the stimulator. Such an arrangement allows for greater subject autonomy in using the stimulator, since the presence of a physician is no longer required once the testing phase is over.

[0032] According to a second aspect, the subject of the present invention is a method for producing a medicament for the treatment of a pulmonary arthritis, comprising: a tracheobronchial air stimulator intended for connection to a subject, the stimulator comprising: a pressure unit configured to generate a set of negative pressure pulses during a relaxation exhalation of the subject, each pulse corresponding to an output of the pressure unit; and a connection assembly configured to connect the pressure unit to the respiratory system of the subject; the automatic control system described above; An assembly comprising:

[0033] According to a third aspect, the subject of the present invention is a method for automatically controlling a tracheobronchial pneumatic stimulator as a function of a measurement of an internal negative pressure, said stimulator comprising a pressure unit configured to generate, during a relaxation exhalation of a subject, a set of negative pressure pulses, each pulse corresponding to an output of the pressure unit, and a connection assembly configured to connect the pressure unit to the respiratory system of the subject; - after each pulse is generated by the pressure unit, measuring the internal negative pressure applied to the subject's respiratory system corresponding to said pulse; comparing the absolute value of the measured internal negative pressure with a predetermined threshold in real time, and determining, based on the comparison result, an updated output value to be applied to the pressure unit so that the absolute value of the subsequent internal negative pressure corresponding to the updated output value is less than the absolute value of the threshold; applying the updated output value to the pressure unit before the next pulse occurs; The method includes:

[0034] According to a fourth aspect, a subject of the invention is a computer program comprising instructions for carrying out at least the computational steps of the method according to the invention when the program is executed by a computer.

[0035] According to a fifth aspect, a subject of the present invention is a non-transitory computer-readable medium comprising instructions for carrying out at least the computational steps of the method according to the invention when said instructions are executed by a computer.

[0036] Features and advantages of the present invention will become apparent from the following description of embodiments of systems and methods for controlling a tracheobronchial air stimulator, which description is given by way of example only and with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0037] [Figure 1] 1 is a schematic diagram of an assembly including a tracheobronchial air stimulator and an automatic control system according to the present invention; [Figure 2] 1 is a graph showing two pulses generated successively during a relaxation exhalation over time. [Figure 3] 1 is a graph showing the change in internal negative pressure over time during relaxation expiration when the tracheobronchial air stimulator is controlled according to the prior art; [Figure 4] 1 shows the main steps of a method for controlling a tracheobronchial air stimulator according to the invention; [Figure 5] 1 is a graph showing the change in internal negative pressure over time during relaxation exhalation for a system and method according to a first embodiment of the present invention for automatic control of a tracheobronchial air stimulator, where the threshold is exceeded twice. [Figure 6]10 is a graph showing the change in internal negative pressure over time during relaxation exhalation for a system and method according to a second embodiment of the present invention for automatic control of a tracheobronchial air stimulator, where the amplitude of the internal negative pressure fluctuates around a threshold value. [Figure 7] 6 is a graph illustrating a variation of the embodiment of FIG. 5, where only a portion of a relaxation exhalation is shown, and the control module generates an increase power command during said portion of the relaxation exhalation. [Figure 8] 1 is a graph showing the output value W of the pressure unit (as a percentage of the total output of the pressure unit) versus time T (in seconds) during relaxation exhalation with a constant internal negative pressure applied to the subject. Several plateaus are identified as W1, W2, and W3. [Figure 9] 1 is a graph showing experimental measurements of the change in internal negative pressure over time (in seconds) during relaxation exhalation for a prior art system and method without an automatic control system. [Figure 10] 1 shows a graph of experimental measurements of the time course of the internal negative pressure (in seconds) during a relaxation exhalation, in the upper part, for a system and method according to an embodiment of the present invention for automatic control of a tracheobronchial pneumatic stimulator, where the amplitude of the internal negative pressure is kept constant (here -40 mBar: dotted line). The lower part of the figure shows the output values ​​reported on the same time axis. The arrows indicate two occurrences of the internal negative pressure exceeding the threshold, followed immediately by a decrease in the output value applied to the pressure unit.

[0038] In the drawings, the same reference numerals in each figure indicate the same or similar elements. For clarity, the elements shown are not drawn to scale unless otherwise specified. Furthermore, these figures do not limit the scope of the claims to the illustrated embodiments. Accordingly, it will be understood that while features referred to in the appended claims are labeled with reference numerals, such numerals are included merely to enhance the comprehension of the claims and do not limit the scope of the claims in any way. DETAILED DESCRIPTION OF THE INVENTION

[0039] The present invention is part of the field of medical support for subjects suffering from respiratory diseases.The following description more specifically refers to the case of a subject suffering from bronchiectasis, but is not limited to this.In other words, the subject faces health problems related to the difficulty of expelling the mucus accumulated in the bronchi from their lungs.Of course, the subject suffering from other medical conditions may also be considered when the subject needs assistance to alleviate respiratory problems.

[0040] In particular, the present invention is applicable to the case of subjects suffering from benign conditions such as colds and bronchitis.

[0041] FIG. 1 shows a schematic representation of an assembly comprising a tracheobronchial air stimulator 10 .

[0042] Conventionally, stimulation device 10 includes a pressure unit 13 and a connection assembly for connecting said pressure unit 13 to the subject's respiratory system. Such a connection assembly allows for the circulation of airflow between the subject's respiratory system and other elements of device 10 used to perform the stimulation, which are described in more detail below.

[0043] 1, the connection assembly includes a tube 11, made, for example, of plastic, to maintain flexibility and facilitate positioning of the subject relative to the device 10. The tube 11 has two ends, one of which is provided with a tip 12 that is inserted into the subject's mouth as part of the connection assembly. The other end is connected to a pressure unit 13.

[0044] The pressure unit 13 is configured to generate a set of negative pressure pulses during the subject's relaxation exhalation, each pulse being associated with an output of the pressure unit 13. The negative pressure pulses correspond to pulses during which negative pressure is generated in the subject's respiratory system to expel air from the subject's own lungs, which air is itself the result of a previous inhalation before the tube tip 12 is placed in the mouth. In other words, the negative pressure pulses correspond to pressures lower than a reference pressure, which in the non-limiting examples herein is considered to be atmospheric pressure. Note particularly in the drawings that atmospheric pressure corresponds to a "0" value on the P axis.

[0045] It should be noted that although the output is associated with the pressure unit 13, it also corresponds to the output of the stimulator 10 itself, and therefore the expressions "output of the pressure unit" and "output of the stimulator" have the same meaning herein.

[0046] Typically, the stimulation device 10 is used by the subject to take multiple relaxation exhalations during a medical assistance session to remove as much mucus as possible and optimize the efficiency of the session. Such a session would therefore include successive relaxation exhalations, with two successive relaxation exhalations separated by an inhalation phase during which the tip 12 is removed from the subject's mouth. For example, a session could include 10 relaxation exhalations, although it is understood that a different number of relaxation exhalations may be contemplated.

[0047] According to a particular embodiment, the pressure unit 13 comprises a vacuum pump and a solenoid valve. Those skilled in the art are well aware of their respective operation, and therefore this will not be further described herein. Furthermore, the pressure unit 13 may be configured differently, for example using different types of valves. Again, those skilled in the art will be able to design alternatives.

[0048] The pressure unit 13 also comprises, for example, one or more processors and storage means (magnetic hard disk, electronic memory, optical disk, etc.) in which data and computer program products are stored in the form of sets of program code instructions that are executed to perform all or part of said pulse generation. Alternatively or additionally, the generation unit 13 comprises one or more programmable logic circuits (FPGA, PLD, etc.) and / or one or more application specific integrated circuits (ASICs) and / or a set of discrete electronic components, etc., suitable for performing all or part of the pulse generation according to predetermined characteristics.

[0049] In other words, the pressure unit 13 comprises, in addition to means such as a vacuum pump and solenoid valves, a set of means configured by software (a specific computer program product) and / or hardware (FPGA, PLD, ASIC, etc.) for generating pulses according to predetermined characteristics as described below.

[0050] 2 corresponds to a graph showing a schematic representation of two pulses 21, 22 generated successively during a subject's relaxation exhalation, with time on the horizontal axis and the negative pressure (in millibars, typically with peak negative pressures ranging from −10 mbar to −80 mbar, preferably −15 mbar to −40 mbar, more preferably −20 mbar to −40 mbar, and even more preferably −30 mbar to −40 mbar) associated with each pulse on the vertical axis. Note that the representation in FIG. 2 is provided for illustrative purposes only, i.e., the number of pulses, particularly during relaxation exhalation, is not limited to two.

[0051] 2, each pulse is generated during a time window 23 of predetermined duration, where the pulse duration is less than the duration of the associated time window. In this way, a period ratio is defined for each time window that is equal to the ratio of the pulse duration to the window duration.

[0052] Preferably, the time windows 23 associated with each pulse generated during relaxation exhalation are all of the same duration, as shown in Figure 2. This approach allows for the simplification of the electronics, and ultimately the cost, for implementing the invention without sacrificing efficient removal of mucus.

[0053] According to a particular embodiment, the pressure unit 13 is configured to generate pulses at at least a predetermined frequency and at least a predetermined period ratio. For example, as shown in FIG. 2, both pulses are generated at a frequency of 12 Hz (the duration of the frequency window associated with each pulse is therefore equal to 1 / 12 seconds), and each pulse has a period ratio of 0.3. These values ​​for frequency and period ratio result in a short, powerful negative pressure, resulting in a stronger liquefaction force due to thixotropy. Alternatively, the two pulses are generated at a frequency of 6 Hz, and each pulse is associated with a period ratio equal to 0.6. These values ​​for frequency and period ratio result in a lower, longer negative pressure than when the frequency and period ratio are equal to 12 Hz and 0.3, respectively. Therefore, the resulting liquefaction force is less significant, but this instead allows for an increased expulsion force by transferring kinetic energy between the air and mucus over a longer period.

[0054] According to yet another alternative, when a subject performs multiple relaxation breaths, some of the breaths are associated with pulses generated at a first frequency f1, and other breaths are associated with pulses generated at a second frequency f2 different from the first frequency f1, and the breaths associated with a given frequency are consecutive. In a non-limiting example, the first frequency f1 and the second frequency f2 are equal to 12 Hz and 6 Hz, respectively. In an even more specific example, the 12 Hz and 6 Hz frequencies are associated with period ratios of 0.3 and 0.4, respectively. This allows not only the removal of mucus but also its expulsion during the entire medical assistance session. However, different frequencies f1 and f2 and different period ratios are also possible.

[0055] The selection of a particular generation frequency constitutes merely a variation for implementing the present invention. It will be apparent to those skilled in the art that, more generally, pulse generation not associated with any predetermined frequency can also be considered. Similarly, the selection of a period ratio equal to 0.3 or 0.6 is merely a variation for implementing the present invention. More generally, the period ratio may be higher than 0.3.

[0056] The stimulator 10 is controlled by a system configured for this purpose, described in more detail below. Controlling the stimulator 10 refers to the fact that the output of the device 10 is adjusted to vary the power associated with each pulse and thus control the variation in the volume of air expelled from the subject's lungs.

[0057] 1, the system includes a pressure sensor 15 configured to measure the internal negative pressure P applied to the subject's respiratory system at least after each pulse is generated by the pressure unit 13. It should be understood that the internal negative pressure P also corresponds to the air pressure at the other end of the tube 11, i.e., the end of the tube 11 attached to the pressure unit 13. Such behavior is the result of the closure of the air circulation circuit between the subject's respiratory system, on the one hand, and the stimulation device 10, on the other hand.

[0058] Such pressure sensors 15 are of a design known per se. In general, the characteristics of pressure sensors are well known to those skilled in the art, who can select the pressure sensor 15 from product catalogs offered by specialized manufacturers. As a non-limiting example, the pressure sensor 15 is a calibrated pressure piezoelectric sensor having a measurement range that includes values ​​from +20 mbar to -300 mbar.

[0059] 1, in this embodiment, the pressure sensor 15 is fixedly positioned inside the pressure unit 13, near the tube that is inserted into the subject's mouth. However, according to other examples not detailed herein, it is also possible to have the pressure sensor 15 positioned differently, as long as it is able to measure the internal negative pressure P. Furthermore, the pressure sensor 15 may be configured to measure the internal negative pressure continuously.

[0060] 3 shows a schematic diagram of the amplitude of the internal negative pressure P (vertical axis) as a function of time (horizontal axis) during relaxation expiration for a stimulator operated according to the prior art, i.e., without control of the delivered power. Typically, this is the situation where an operator (or may be a subject) has selected, e.g., before use, a predetermined power program, which corresponds to a constant power operation during relaxation expiration.

[0061] In this example, each bar corresponds to the amplitude of the internal negative pressure P when generating a negative pressure pulse, and has a width representing the duration for which the negative pressure pulse is generated. Note that the bars are now regularly spaced, corresponding to a configuration in which negative pressure pulses are generated at a fixed frequency, with each pulse occurring at a generation time t i (In this example, the subscript i ranges from 1 to 8.) As shown in FIG. 3, the amplitude of the internal negative pressure P increases in absolute value with each negative pressure pulse. This is due to the fact that the volume of air in the lungs decreases while the delivered power remains constant. Also, note that the internal negative pressure P shown in FIG. 3 differs from the negative pressure shown in FIG. 2 because it corresponds to a negative pressure associated with only one pulse, i.e., independent of any closed system in which such negative pressure occurs.

[0062] The system of the present invention aims to control the increase, such as that observed in FIG. 3, by implementing a method for controlling this output during each relaxation exhalation.

[0063] For this purpose, the system comprises, in addition to the pressure sensor 15, several modules: an acquisition module 31, a calculation module 32 and a control module 33.

[0064] Each module 31, 32, 33 comprises one or more processors and storage means (magnetic hard disk, electronic memory, optical disk, etc.) on which data and computer program products are stored in the form of sets of program code instructions that are executed to implement all or part of said control methods. Alternatively or additionally, each module 31, 32, 33 comprises one or more programmable logic circuits (FPGA, PLD, etc.), and / or one or more application specific integrated circuits (ASICs) and / or a set of discrete electronic components, etc., suitable for implementing all or part of the control methods.

[0065] In other words, each module comprises a set of means constituted by software (a specific computer program product) and / or hardware (FPGA, PLD, ASIC, etc.) for performing the steps of the control method, and can therefore be executed automatically.

[0066] According to a preferred embodiment, as shown in Figure 1, all modules, namely the acquisition module 31, the calculation module 32 and the control module 33, are integrated into the pressure unit 13 as specific electronic circuits. Such an embodiment also makes it possible to increase the tightness of the assembly formed by the control system and the stimulation device 10.

[0067] The option of integrating all modules into the pressure unit 13 is merely one variant of realization of the invention. In one variant, all or some of the modules 31, 32, 33 may be positioned outside the pressure unit 13. For this purpose, when the modules 31, 32, 33 are positioned remotely from the pressure unit 13, they are equipped with communication means (wired or wireless communication means) known per se for communicating with the other modules as well as with the pressure unit 13 and the pressure sensor 15.

[0068] As a non-limiting example (not shown in the drawings), all modules 31, 32, 33 are positioned remotely from pressure unit 13 and assembled into a single unit configured to be physically connected to stimulation device 10, e.g., more specifically, pressure unit 13.

[0069] According to yet another example, the acquisition module 31 and the control module 33 are both integrated in the pressure unit 13, and the computing module 32 is located remotely from the latter. In such a configuration, the computing module 32 corresponds to computing means integrated in one or more computer servers located close to the stimulation device 10 or in one or more remote computer servers according to a cloud computing solution.

[0070] FIG. 4 shows a schematic representation of the main steps of a method according to the invention for controlling the stimulation device 10.

[0071] In this method, each of the modules 31, 32, 33 of the system plays a specific role. As shown in Figure 4, the control method first includes a generating step 50 in which a set of negative pressure pulses is generated using the pressure unit 13 during the subject's relaxation exhalation. The control method includes, for at least a subset of the pulses in the set: a step 51 of measuring, after each pulse of the subset of pulses, an internal negative pressure P associated with said pulse using a pressure sensor 15; a step 52 of acquiring the internal negative pressure P measured during the measurement step 50 using the acquisition module 31; a step 53 of comparing the measured internal negative pressure P with a predetermined threshold value S and determining, based on the result of the comparison, an updated output value to be applied to the pressure unit 13 so that the subsequent internal negative pressure P resulting from the updated output value is less in absolute value than the absolute value of the threshold value S, said comparison and determination step 52 being carried out using the calculation module 32; applying 54 the updated output value to the pressure unit 13 using the control module 33 before the generation of the next pulse; Further includes:

[0072] As mentioned above, the steps subsequent to generating step 50, namely, measuring internal negative pressure P 51, obtaining internal negative pressure P 52, comparing the measured internal negative pressure P with a predetermined threshold S and determining an updated output value 53, and applying the updated output value 54, are performed for at least a subset of pulses of the entire set of negative pressure pulses after each pulse of said subset is generated. This means that after each pulse of said subset, steps 51, 52, 53, and 54 are performed before the next pulse, i.e., in real time, and then repeated.

[0073] With respect to "at least a subset," we refer to the fact that considering a subset grouping multiple pulses is equivalent to considering a union (in terms of algebra) of multiple subsets grouping said multiple pulses. For example, purely for illustrative purposes, if a set of pulses is represented as {P1, P2, P3, P4}, the subset corresponding to {P1, P3, P4} will be considered, for purposes of implementing the present invention, equivalent to the union of the subsets corresponding to {P1} and {P3, P4}, respectively.

[0074] In the remainder of this specification, threshold S is considered, without limitation, to be a value corresponding to a comfort limit determined during use of stimulation device 10 by a subject. In other words, it corresponds to the subject's tolerance threshold S for operation of stimulation device 10. Typically, such tolerance threshold S represents a level of negative pressure above which, if negative pressure pulses continue for a sufficiently long time, the subject experiences respiratory discomfort, forcing them to remove tip 12 from their mouth to inhale. For example, this respiratory discomfort reflects an unpleasant sensation felt by the subject in the chest. Additionally or alternatively, the discomfort felt may be related to the subject's need to cough. Therefore, it is understood that the threshold thus determined will vary for each subject.

[0075] According to certain embodiments, the threshold value S is a predetermined value determined by the subject alone or with the assistance of a physician during a testing phase of the stimulator 10. This approach increases the subject's autonomy in using the stimulator 10, since the presence of a physician is no longer required once the testing phase is over. Furthermore, when a subject is using the stimulator 10 for the first time, the threshold value S may be set based on, for example, an average value determined during a testing campaign previously conducted on volunteer subjects.

[0076] In general, different types of thresholds may be considered, and the choice of the type of threshold merely constitutes a variation in the implementation of the invention. For example, the threshold S may correspond to a value defined solely on the basis of past measurements of the maximum volume of air contained in the subject's lungs, and not according to the subject's emotions.

[0077] In a preferred embodiment, the threshold value is in the range of -15 mbar to -40 mbar, preferably -20 mbar to -40 mbar.

[0078] As indicated above, the control method performs its steps for at least one subset of the entire set of pulses, with possible examples of such subsets being described in more detail below. Also, the embodiment of the steps shown in Figure 4 will be described in more detail below, considering examples where the updated output value corresponds to a decreased output value (Figure 5), an example where the internal negative pressure P fluctuates around a threshold value S (Figure 6), and an example where the updated output value corresponds to an increased output value (Figure 7).

[0079] A) Specific Embodiments for Power Reduction According to a particular embodiment, the calculation module 32 is configured to determine during the comparison and determination step 53 whether the absolute value of the measured internal negative pressure P exceeds the absolute value of the threshold value S, and if so, to determine a reduced output value to be applied to the pressure unit 13. For example, the absolute value of the threshold value S is subtracted from the absolute value of the measured internal negative pressure P, and an exceedance is detected if the resulting difference is positive. The resulting difference is referred to as the "comparison result."

[0080] In a more specific embodiment, the calculation module 32 is configured to determine the reduced output value as a function of the difference between the measured internal negative pressure P and the threshold value S, such that the subsequent internal negative pressure P is associated with a reduced pressure unit output value by a value between 1% and 10% of the full range of the pressure unit output value. For example, the difference is equal to the difference calculated during comparison 53. Selection of such a range advantageously reduces the internal negative pressure P sufficiently so that the subject does not experience any respiratory discomfort and can therefore continue to use the stimulation device 10. In other words, the subject does not feel the need to remove the tip 12 from their mouth, and their lungs continue to empty, thereby enhancing mucus clearance. Targeting a specific range also allows the system to finely control the operation of the stimulation device 10.

[0081] In general, the design (software / hardware) of the output commands intended to be applied by the control module 33 to the stimulator 10 can be done according to any method known to those skilled in the art to achieve a particular range for the threshold S. Thus, the selection of a particular method for designing the output commands constitutes a mere variation for implementing the present invention.

[0082] FIG. 5 shows a schematic representation of the amplitude (vertical axis) of the internal negative pressure P as a function of time (horizontal axis) during relaxation exhalation, where the output of the pressure unit 13 is reduced to optimize mucus evacuation, which corresponds to an improvement over the embodiment shown in FIG. 3.

[0083] As shown in Figure 5, 12 negative pressure pulses are generated at a fixed frequency during relaxation. The pulse times are t1, t2, ..., t 12 The internal negative pressure P associated with each pulse is represented by a bar whose length represents the amplitude of the internal negative pressure P. The associated amplitude value is written below each bar. The output of the pressure unit 13 is initially set so that the amplitude of the internal negative pressure P associated with the pulse is −25 mbar. A threshold value S is set to −80 mbar and is represented by a dotted line. The threshold value may be adjusted to −70 mbar, −60 mbar, preferably −40 mbar, or more preferably −30 mbar depending on the subject. The calculation module 32 is also configured to generate a reduced output value, which is further applied to the pressure unit 13 by the control module 33, when the threshold value S is reached so that the internal negative pressure P associated with the next pulse is approximately −30 mbar. This reduced output value determines the output level of the device 10 for the continuation of the process unless another updated output value is calculated. Two reduced output values ​​are then calculated during the entire relaxation exhalation, at times t4 and t8, respectively; the reduced power value calculated at time t4 corresponds to a power reduction from -80 mbar to -30 mbar; It can be observed that the reduced power value calculated at time t8 corresponds to a decrease in power from -80 mbar to -30 mbar. It should be noted that the subject's lungs are emptying between pulses 1 and 8. This explains why the same power value of the pressure unit produces different and increasing internal negative pressures.

[0084] Finally, the relaxation breath reaches a time t without reaching the threshold S again. 12 and ends.

[0085] If the reduced output value is not generated, the internal negative pressure P continues to increase gradually from t4 until the subject can no longer tolerate the resulting discomfort, and the relaxation exhalation occurs at t 12It is advantageous to proceed in this way, as the project would have ended prematurely well before the deadline.

[0086] 5, it should be noted that unless a power reduction control occurs, the internal vacuum P is considered to increase in unmodified increments. It is important to note that this is merely a variation for implementing the present invention. All of the embodiments described with respect to the present invention, particularly those relating to the generation of reduced power values, can be adapted to embodiments relating to increased power values, which are described in more detail below.

[0087] 5, the subset of negative pressure pulses measured 51, obtained 52, compared and determined 53, and applied 54 consists of pulses generated at times t4 and t8, respectively. However, it should be noted that other embodiments regarding the composition of said subset are possible, so long as they contribute to maximizing exhalation time.

[0088] For example, it is possible to have subsets with consecutive pulses (e.g., times t4, t5, etc.) such that once threshold S is exceeded for the first time, it is not exceeded again during relaxation exhalation. It is also possible to have subsets with pulses that are more / less spaced apart, as well as more than two pulses or only one pulse, compared to the example of Figure 5.

[0089] FIG. 6 shows a schematic representation of a variant of FIG. 5, in which the output of the pressure unit 13 is initially set so that the internal negative pressure P associated with the pulse is −25 mbar; the calculation module 32 is configured to determine a reduced output value such that, when the threshold value S is reached, the internal negative pressure P associated with the next pulse is approximately −65 mbar; a next pulse is generated with the internal negative pressure P below the threshold S, at about -65 mbar; Then, resetting the output value of the pressure device to an output value corresponding to the internal negative pressure P exceeding the threshold S, and generating a pulse; Repeat the last two subsets of pulses below and above the threshold S.

[0090] Thus, in this example, the output control is understood to be a local (ie, temporary) control that does not reduce the output of the stimulator 10 during the remaining relaxation exhalation.

[0091] As shown in FIG. 6, the subsets are t4, t6, t8, t 10 and t 12 The amplitude of the internal negative pressure P is therefore varied around the threshold S. This is particularly advantageous when the subject can tolerate the operation of the device and does not require excessive reduction in output. Varying around the threshold S optimizes the use of the stimulation device 10 by maximizing not only the duration of relaxation expiration but also the output that clears mucus.

[0092] It should be noted that the selection of a subset of pulses occurring every other time represents just one variant of an embodiment of the present invention: in general, the subset may consist of pulses selected according to a particular period of fluctuation around the threshold S.

[0093] The remainder of this specification relates to other specific embodiments for power reduction that maintain compatibility with all the technical features described above with respect to the selection of the subset structure.

[0094] According to another particular embodiment, the output reduction determined during the comparing and determining step 53 corresponds to a reduced output value determined among a set of predetermined output values. For example, the predetermined values ​​are substantially equal to multiples of one-tenth of the maximum output of the stimulator 10, i.e., 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, and 10%. Thus, the reduced output values ​​can be preprogrammed, simplifying the electronic architecture of the control module 33.

[0095] According to certain embodiments, when several reduced output power values ​​are determined by the calculation module 32 during the subject's relaxation exhalation, the values ​​form a regular sequence over time. In other words, the rate of output power reduction remains the same each time the time threshold S is exceeded. For example, the output power reduction is set to 25%. According to this example, if the relaxation exhalation phase begins with the full output of the pressure unit 13, the stimulator 10 operates at 75% of its maximum output power after exceeding a first threshold S, then at 50% of its maximum output power after exceeding a second threshold S, and so on. This progression allows the subject to adapt more easily to the operation of the stimulator 10, so that the subject is not rushed during relaxation exhalation. Furthermore, it should be noted that such an embodiment is not limited to selecting a fixed value for the output power reduction, but can be adapted to target specific intervals relative to the threshold S.

[0096] B) Specific embodiments for increased power output All features described above in section A regarding the reduction of the output of the pressure unit 13 are applicable to the following description of embodiments for increasing the output of said pressure unit 13 .

[0097] According to a particular embodiment, the calculation module 32 is configured to determine whether the absolute value of the measured internal negative pressure P exceeds the absolute value of the threshold value S and, if not, to calculate an increased power value to be applied to the pressure unit 13. For example, the absolute value of the threshold value S is subtracted from the absolute value of the measured internal negative pressure P, and if the resulting difference is negative, no exceedance is detected. The resulting difference is referred to as the "comparison result."

[0098] In a more specific embodiment, the calculation module 32 is configured to determine the increased output value as a function of the difference between the measured internal negative pressure P and the threshold value S, such that the subsequent internal negative pressure P is associated with an increased output value of the pressure unit by a value between 1% and 10% of the full range of the output value of the pressure unit. For example, said difference is equal to the difference calculated during comparison 53. Selection of such a range advantageously prevents the stimulation device 10 from operating at too low an output rate, such that not enough air is expelled from the lungs with each pulse. In other words, proceeding in this manner increases the efficiency of the device 10 by avoiding not enough mucus being expelled during each relaxation exhalation until the threshold value S is reached.

[0099] FIG. 7 shows a schematic representation of the amplitude (vertical axis) of the internal negative pressure P as a function of time (horizontal axis) during a portion of a relaxation exhalation, where the power increase is controlled for some of the pulses shown, and where the threshold S is reached only once. It should be noted that FIG. 7 is constructed according to a similar configuration to that used in FIG. 5, except that only a portion of a relaxation exhalation is represented (only four occurrences are shown).

[0100] As shown in FIG. 7, four negative pressure pulses are generated at a fixed frequency during relaxation exhalation. The pulse generation times are represented by t1, t2, t3, and t4, respectively. The output of the pressure unit 13 is initially set so that the internal negative pressure P associated with the pulse is −10 mbar. The threshold S is set to −80 mbar. The calculation module 32 is also configured to determine an increased output value once the first pulse is generated. This increased output value defines the output level of the device 10 for the continuation of the process unless another updated output value is determined. Therefore, the internal negative pressure P associated with the pulse from t2 is therefore −50 mbar. Therefore, at time t3, the internal negative pressure P after the output increase is −75 mbar, which is less than the threshold S. The process then continues without changing the output of the pressure unit 13. If the threshold S is exceeded, the calculation module 32 determines a decreased output value, for example, according to the present embodiment (not shown in FIG. 7) described above.

[0101] Note that if no power increase occurs, the threshold S will only be reached after a later time t5, which may be limited if it corresponds to a duration that is too long compared to the start of the relaxation-expiration phase.

[0102] 7, the subset of negative pressure pulses for which the steps of measuring 51, obtaining 52, comparing and determining 53, and applying 54 were performed consists of a single pulse generated at time t2. However, other embodiments of the composition of the subset are possible, as long as they contribute to maximizing exhalation time.

[0103] In general, all considerations regarding the composition of the subsets explained in section A apply equally to the case of power increase: in other words, apart from respecting maintaining below the threshold for pulses after power increase, it is not excluded that said subsets comprise a single or several pulses, are consecutive or non-consecutive, etc.

[0104] C) Specific embodiments for constant internal negative pressure The combination of the features described above in Section A relating to decreasing the output of the pressure unit and Section B relating to increasing the output of the pressure unit enables certain embodiments of the present invention.

[0105] In this embodiment, a predetermined value of the internal negative pressure P0 is selected, typically in the range of -15 mbar to -40 mbar, with the exact value of P0 being determined according to the subject's characteristics such as anatomy, medical condition, lung volume, cough sensitivity, and the efficiency of air evacuation and / or mucus clearance.

[0106] The system is then instructed to deliver an internal negative pressure P0 to the subject by adjusting the output value of the pressure unit. The output value of the pressure unit may be recorded over time as shown in FIG.

[0107] In the first stage, the air is expelled easily and the volume of air in the lungs is large, resulting in a high output value.

[0108] The output value then reaches the plateau W plat or until successive plateaus of decreasing power output are reached (e.g., shown as W1, W2, and W3 in FIG. 8). Air evacuation and / or mucus removal may be achieved if the plateaus are long, i.e., at operating points (P0; W plat ) is observed to be stable over time.

[0109] In the final stage, the output value decreases again, which corresponds to the end of relaxation expiration.

[0110] Therefore, an advantageous use of the device is to record the output value of the pressure unit versus time to identify the optimum operating point of the device for a subject.

[0111] In another advantageous use, successive records (e.g., weekly or monthly) of the pressure unit's output values ​​over time may be compared to monitor the subject's condition. plat A decrease in the pulmonary status of the subject indicates an improvement in the subject's pulmonary status.

[0112] While various embodiments have been described and illustrated, the detailed description of the invention should not be construed as limiting thereof. Various modifications to those embodiments may be made by those skilled in the art without departing from the spirit and scope of the present disclosure, as defined by the claims. [Example]

[0113] Example 1: Comparison of a tracheobronchial pneumatic stimulator with an automatic control system and a tracheobronchial pneumatic stimulator without an automatic control system

[0114] This example was performed on the same subject during two different treatment sessions: during the first treatment session, the subject was fitted with a tracheobronchial air stimulator without an automatic control system, and during the second treatment session, the subject was fitted with a tracheobronchial air stimulator with an automatic control system.

[0115] During a first treatment session, a set of negative pressure pulses is generated using the pressure unit during the subject's relaxation exhalation.

[0116] FIG. 9 shows the amplitude (vertical axis, mBar) of the internal negative pressure P as a function of time (horizontal axis, seconds) during a portion of the relaxation exhalation, in which the internal negative pressure was uncontrolled and repeatedly reached and exceeded a threshold S (-30 mBar, represented by the dotted line).

[0117] Without the automatic control system, no correction is made to the pressure units when the threshold S is reached, resulting in many exceedance events. In this case, the internal negative pressure is maintained above the threshold for too long. The relaxation exhalation is stopped prematurely by the subject (recorded at 9 seconds, corresponding to an exhalation of less than 7 seconds) due to discomfort and the need to cough. Finally, the relaxation exhalation does not occur for a long enough period of time to allow the subject to completely empty their lungs of the air they contain. Therefore, the amount of mucus expelled during the relaxation exhalation is not optimal, the treatment is not efficient, and another treatment session is required to achieve satisfactory mucus expulsion.

[0118] During the second treatment session, a set of negative pressure pulses is generated using the pressure unit during the subject's relaxation exhalation.

[0119] According to the method of the present invention, during said session: measuring the internal negative pressure P using the pressure sensor 15 after each pulse of the subset of pulses; The internal negative pressure P measured during the measurement process is acquired using an acquisition module 31, comparing the measured internal negative pressure P with a predetermined threshold value S and determining, based on the comparison result, an updated output value to be applied to the pressure unit 13 such that the subsequent internal negative pressure P resulting from the updated output value is less in absolute value than the absolute value of the threshold value S, said comparing and determining steps being carried out using a calculation module 32; · Applying the updated output value to the pressure unit 13 using the control module 33 before the next pulse occurs.

[0120] The steps of measuring the internal negative pressure P, acquiring the internal negative pressure P, comparing the measured internal negative pressure P with a predetermined threshold S and determining an updated output value, and applying the updated output value are performed before the next pulse, i.e., in real time, and then repeated.

[0121] FIG. 10 shows in the upper part the amplitude of the internal negative pressure P (vertical axis) and in the lower part the output value W of the pressure unit (as a percentage of the total output of the pressure unit), both as a function of time (horizontal axis) during a portion of relaxation exhalation, in which the internal negative pressure is controlled.

[0122] It can be observed that if the absolute value of the measured internal negative pressure P exceeds the absolute value of the threshold value S (-30 mBar, represented by the dotted line), a reduced output value is determined and applied in real time to the pressure unit 13 (see arrow in Figure 10), which results in a real time reduction of the internal negative pressure P back below the threshold value S.

[0123] In this case, the excess of the internal negative pressure will not continue at least for the next pulse, thus preventing the internal negative pressure from exceeding the threshold for too long and preventing premature termination of the relaxation exhalation.The automatic control system for the tracheobronchial air stimulator of the present invention allows the subject to perform relaxation exhalation for a sufficiently long period (here, more than 12 seconds) so as to completely empty the air contained in their lungs, thereby promoting the expulsion of mucus during relaxation exhalation.

[0124] When an automatic control system with a tracheobronchial pneumatic stimulator is used, the optimum internal negative pressure is maintained constant throughout the pulse, but without this control system, the maximum internal negative pressure varies widely, which can cause the subject to experience high respiratory discomfort and the need to prematurely terminate the treatment session.

[0125] As shown in Figure 10, automatic control reduces the amplitude of the internal negative pressure P so that the amplitude of the internal negative pressure P at the end of a relaxation exhalation is smaller than the amplitude of the internal negative pressure P at the beginning of the same relaxation exhalation. This allows for a smooth end to the relaxation exhalation by preparing the lungs to return to normal pressure, preventing the subject from having to cough. In contrast, in Figure 9, it can be observed that without automatic control, the amplitude of the internal negative pressure P remains approximately constant throughout the relaxation exhalation. This may result in a more traumatic outcome for the subject compared to a relaxation exhalation performed with the assistance of the automatic control system of the present invention.

Claims

1. An automatic control system for a tracheobronchial air stimulator (10) intended to be connected to a subject, said stimulator (10) comprising: a pressure unit (13) configured to generate a set of negative pressure pulses during relaxation exhalation of the subject, each pulse corresponding to an output of the pressure unit (13); a connection assembly (11, 12) configured to connect the pressure unit (13) to the subject's respiratory system; The control system comprises: a pressure sensor (15) configured to measure an internal negative pressure (P) applied to the subject's respiratory system corresponding to each pulse after it is generated by the pressure unit (13), the internal negative pressure (P) being the pressure at the inlet of the subject's respiratory system; a calculation module (32) configured to compare the absolute value of the measured internal negative pressure (P) with a predetermined threshold value (S) in real time and to determine, based on the comparison result, the updated output value to be applied to the pressure unit (13) so that the absolute value of the subsequent internal negative pressure (P) corresponding to the updated output value is less than the absolute value of the threshold value (S); a control module (33) configured to apply the updated output value to the pressure unit (13) before the generation of the next pulse; A system comprising:

2. 2. The system of claim 1, further comprising an acquisition module (31) configured to acquire a value of the measured internal negative pressure (P) associated with each pulse during relaxation exhalation of the subject after the pulse is generated by the pressure unit (13).

3. 3. The system according to claim 1, wherein the calculation module (32) is configured to determine whether the absolute value of the measured internal negative pressure (P) exceeds the absolute value of the threshold value (S) and, if so, to determine a reduced power value to be applied to the pressure unit (13).

4. 4. The system of claim 3, wherein the calculation module (32) is configured to determine the reduced output value as a function of the difference between the absolute value of the measured internal negative pressure (P) and the absolute value of the threshold value (S), such that the absolute value of the subsequent internal negative pressure (P) corresponding to the reduced output value is reduced by a value of 10 mbar to 60 mbar compared to the last measured internal negative pressure (P).

5. 5. The system according to claim 3, wherein the reduced power output value is determined from a set of predetermined power output values, in particular such that each predetermined power output value is substantially equal to a multiple of one-tenth of the maximum power output of the pressure unit (13).

6. 6. The system according to claim 1, wherein the calculation module (32) is configured to determine whether the absolute value of the measured internal negative pressure (P) exceeds the absolute value of the threshold value (S) and, if not, to determine an increased power value to be applied to the pressure unit (13).

7. 7. The system of claim 6, wherein the calculation module (32) is configured to determine the increased output value as a function of the difference between the absolute value of the measured internal negative pressure (P) and the absolute value of the threshold value (S), so as to increase the subsequent internal negative pressure (P) corresponding to the increased output value by a value of 10 mbar to 60 mbar compared to the last measured internal negative pressure (P).

8. The pressure unit (13) generates a first set of successive exhalations at a first frequency (f) for a plurality of relaxation exhalations of the subject. １ ) to the pulses generated by said pressure unit (13), and a second set of successive exhalations are generated at said first frequency (f １ ) a second frequency (f ２ 8. The system according to claim 1, wherein the system is configured to associate a pressure value with the pulses generated by the pressure unit (13).

9. The first frequency (f １ ) is equal to 12 Hz, and the second frequency (f ２ 9. The system of claim 8, wherein: ) is equal to 6 Hz.

10. The system according to any one of claims 1 to 9, wherein the threshold (S) is a value corresponding to a comfort limit determined by the subject during use of the stimulation device (10).

11. The system according to any one of claims 1 to 9, wherein the threshold (S) is a predetermined value determined during a testing phase of the stimulator (10).

12. The system of any one of claims 1 to 11, wherein the pressure sensor (15) comprises a calibrated pressure piezoelectric sensor.

13. The system of claim 12, wherein the pressure sensor (15) is configured to measure values ​​between +20 mbar and -300 mbar.

14. a tracheobronchial air stimulator (10) intended to be connected to a subject, the stimulator (10) comprising a pressure unit (13) configured to generate a set of negative pressure pulses, each pulse corresponding to the output of the pressure unit (13), during a relaxation exhalation of the subject, and a connection assembly (11, 12) configured to connect the pressure unit (13) to the respiratory system of the subject; - an automatic control system according to any one of claims 1 to 13; An assembly comprising:

15. 1. A method for automatically controlling a tracheobronchial air stimulator (10) as a function of a measured internal negative pressure (P), said stimulator (10) comprising a pressure unit (13) configured to generate a set of negative pressure pulses, each pulse corresponding to an output of the pressure unit (13), during a subject's relaxation expiration, and a connection assembly (11, 12) configured to connect said pressure unit (13) to the subject's respiratory system; - measuring (51) after each pulse generated by the pressure unit (13) an internal negative pressure (P) applied to the subject's respiratory system corresponding to said pulse, said internal negative pressure (P) being the pressure at the inlet of the subject's respiratory system; a step (53) of comparing the absolute value of the measured internal negative pressure (P) with a predetermined threshold value (S) in real time and determining, based on the comparison result, the updated output value to be applied to the pressure unit (13) so that the absolute value of the subsequent internal negative pressure (P) corresponding to the updated output value is less than the absolute value of the threshold value (S); - applying (54) said updated output value to said pressure unit (13) before the generation of the next pulse; A method comprising:

16. 16. A computer program comprising instructions for carrying out at least the calculation steps of the method according to claim 15 when the program is executed by a computer.

17. 16. A non-transitory computer-readable medium containing instructions for performing at least the computing steps of the method of claim 15 when the instructions are executed by a computer.

18. 16. The method of claim 15, wherein the measuring step (51) is performed using a pressure sensor (15) that includes a calibrated pressure piezoelectric sensor.

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