WO2020170108A1

WO2020170108A1 - A medical device for the exercise of a user's respiratory functions and non-therapeutic monitoring and data collection method

Info

Publication number: WO2020170108A1
Application number: PCT/IB2020/051302
Authority: WO
Inventors: Pietro Maria PICOTTI
Original assignee: Picotti Pietro Maria
Priority date: 2019-02-18
Filing date: 2020-02-17
Publication date: 2020-08-27
Also published as: IT201900002317A1

Abstract

A medical device (1) for the exercise of a user's respiratory functions comprises a conduit (2) for the exhalation and inhalation of air, first detection members (3) configured to detect a first plurality of signals representing the respiratory function values, an adjustment element (5) configured to adjust the intake of a flow of ambient air (F) into the conduit (2) as a function of the first plurality of detected signals and a control unit (6) connected to said first detection members (3) and to said adjustment element (5) in order to move the latter as a function of the detected signals. The medical device (1) further comprises second detection members (4) operatively applicable to specific body areas of the user in order to detect a second plurality of signals representing the respiratory and postural parameters of the user himself. The subject matter of the present patent application also relates to a non-therapeutic method for the exercise of a user's respiratory functions.

Description

“A MEDICAL DEVICE FOR THE EXERCISE OF A USER’S

RESPIRATORY FUNCTIONS AND NON-THERAPEUTIC MONITORING

AND DATA COLLECTION METHOD”

_{* * * * *}

DESCRIPTION

Technical Field

The present invention relates to a medical device for the exercise of a user’s respiratory functions.

In particular, the invention relates to a medical device configured to improve and optimize a user’s respiratory functions, and even more in particular to increase the user’s ventilatory capacity.

In addition, the invention relates to a non-therapeutic method for monitoring and collecting data on a user’s respiratory functions.

The invention has particular application within the physiotherapy field.

Prior Art

The breathing process, apparently simple and intuitive, is generally compromised by a multitude of involuntary errors of execution, which reduce its efficiency.

In particular, respiratory muscle work is closely correlated with the motor fatigue suffered by a subject during a work session. In fact, several studies have demonstrated that the increase in the oxygen demand (and thus the blood flow demand) of respiratory muscles provokes a peripheral vasoconstriction that causes a reduction in the blood flow to the lower limbs, with a consequent reduction in motor performance.

Some researchers have hypothesized that training the respiratory muscles can attenuate the perception of both respiratory and peripheral muscle fatigue, simultaneously with an improvement in the exercise capacity. In detail, training the respiratory muscles entails increasing work either in terms of resistance or in terms of ventilation. Whereas the former method has limited effects on the efficiency of respiratory muscles, the second method can give rise to the set of symptoms due to hypocapnia induced by hyperventilation. A group of Swiss researchers, therefore, developed a device capable of training respiratory muscles without overloading the musculoskeletal apparatus and the cardio-circulatory system and avoiding hypocapnia, using the method of isocapnic hyperpnea.

Several of such devices capable of training the respiratory muscles presently exist on the market.

However, to date, the devices on the market have not been able to train both strength and resistance rapidly and with maximum loads, with precise indications as to the performance of the work the subject is performing.

In addition, the devices on the market do not provide any information regarding the physical condition of the subject before, during and after the execution of respiratory-functional activities.

Consequently, such devices, as they do not provide real-time feedback about the physical conditions of the subject himself, are not able to reveal any errors committed which could be corrected in a substantially instantaneous manner for better efficiency in carrying out the aforesaid motor activities.

Document W02017/072036A1 illustrates a spirometer configured to enhance lung strength, provided with sensors configured to detect solely the parameters that are closely tied to respiratory functions. Furthermore, according to a described embodiment, a gas canister is housed in the base of the spirometer, to provide gas to the user at a pressure above atmospheric pressure.

Document WO01/19439A1 discloses a respiratory effort sensor for measuring the movements of the suprasternal notch in response to respiratory efforts as opposed to measuring the respiratory airflow or pressure of a mask worn by the patient.

Document W003/024505A2 discloses an apparatus and a method for the use thereof, which is configured to provide a man who uses it with a quantity of air having a lower oxygen concentration than the ambient air.

In particular, the document discloses an apparatus for inducing hypoxia for short periods by supplying air enriched with nitrogen (and thus having a reduced concentration of oxygen) in an isobaric environment to simulate various elevations above sea level.

Description of the invention

The present invention aims to eliminate or at least reduce the drawbacks and disadvantages typical of the prior art and hence to propose a medical device for the exercise of respiratory functions which is configured to provide the user with information regarding both his respiratory system (data on respiratory muscles, breathing efficiency ...) and the correlated physical conditions, in order to optimize his breathing and physical condition.

In particular, one object of the present invention is to provide a medical device for the exercise of respiratory functions that is capable of training the strength and resistance of respiratory muscles and, at the same time, of improving the subject’s posture during this operation.

In addition, another object of the present invention is to provide a medical device for the exercise of respiratory functions that is capable of providing the user with real-time information related to his breathing and physical condition so as to correct any problems in real time.

Finally, the invention aims to offer a non-therapeutic method for monitoring and collecting data on a user’s respiratory functions.

The stated technical task and specified objects are substantially achieved by a medical device for the exercise of respiratory functions which comprises the technical features set forth in claim 1. The dependent claims outline particularly advantageous embodiments of the invention. Furthermore, claim 1 1 discloses a method for the exercise of a user’s respiratory functions.

The invention relates to a medical device for the exercise of a user’s respiratory functions. The medical device comprises a conduit, first detection members, second detection members, an adjustment element and a control unit.

The conduit extends between a ventilation opening which the user can use to inhale and exhale a predetermined volume of air, and an air recirculation opening in fluid connection with the ambient air from which to inhale or exhale at least part of the volume of air.

The first detection members are arranged inside the conduit and are configured to detect, from the volume of air, a first plurality of signals representing the typical respiratory function values, including, for example the level of carbon dioxide present in the flow of air.

The adjustment element is associated with the recirculation opening of the conduit for adjusting the intake of a flow of ambient air during inhalation as a function of the first plurality of signals detected by the first detection members. In particular, the adjustment element is alternately configurable in any intermediate condition between a closed condition, wherein the passage of the flow of ambient air is disabled, and an open condition, wherein the passage of the flow of ambient air is enabled.

The control unit is connected to the adjustment element and to the first detection members for receiving the first plurality of detected signals. In addition, the control unit is connected so to move the adjustment element between the open condition and the closed condition as a function of the first plurality of detected signals.

The second detection members are operatively applicable to specific body areas of the user, including the sternal area, the shoulders and the spine, to detect a second plurality of signals representing the respiratory and postural parameters of the user himself. In addition, the second detection members are configured to send the second plurality of detected signals to a receiving module of the control unit.

In other words, during an exercise session the user carries out a repeated series of exhalations and inhalations of a volume of air depending on his lung and chest capacity. Advantageously, during inhalation of the flow of ambient air, the adjustment element can be moved into the open condition to enable mixing between the ambient air and any part of the previously exhaled air that was not totally expelled from the medical device, so as to maintain the ratio between the amounts of oxygen and carbon dioxide inhaled by the user substantially stable in order to avoid phenomena of hypocapnia and/or hypercapnia. Even more advantageously, during the exercise session, the user wears the second detection members capable of detecting the work performed by the respiratory muscles and, in general, the user’s posture. A correct posture, in fact, modifies the conformation of the rib cage, thereby optimizing ventilation and hence the oxygenation of blood. Likewise, good respiratory function guarantees the user an optimization of posture.

Advantageously, the medical device simultaneously affects two of the major systems that are essential to man’s survival: the respiratory system and postural system. In addition, the medical device acts on said systems in advantageously short times and with a stimulation time of just a few minutes in order to obtain the first results.

Preferably, the second detection members comprise a shirt that can be worn by the user and a plurality of sensors connected to the inside of the shirt so as to enter into contact with the user’s specific body areas of interest when the shirt is being worn. In detail, the sensors are configured to detect the second plurality of signals, including a range of movement of the rib cage, a range of movement of the abdominal wall, and a heart rate.

Advantageously, the shirt in which the sensors are arranged can be easily worn by the user, in addition to being light and breathable and allowing the plurality of sensors to be positioned with a single action on all the different areas of interest to be monitored during the breathing exercise session.

According to one aspect of the invention, the first detection members comprise a plurality of detectors configured to detect the first plurality of signals, including minute ventilation, a force applied during inhalation or the exhalation of the air flow and an airflow rate.

Advantageously, the plurality of detectors allows the physicochemical characteristics of the flow of air inhaled and exhaled by the user to be monitored so as to enable the recording of the respective values of the inhalation and exhalation force and the respiratory rate, as well as the amounts of carbon dioxide contained, essential for regulating the activation or deactivation of the valve.

According to another aspect of the invention, the adjustment element comprises an air filter adapted to allow the emission of the volume of air into the ambient air and to adjust the intake of the flow of ambient air into the conduit during inhalation as a function of the first plurality of signals.

In this manner, it is not necessary to install a container for collecting the volume of exhaled air at the recirculation opening, thus reducing the complexity and overall dimensions of the structure of the medical device and increasing its portability. In fact, the filter, being alternately configurable between the open and the closed condition, is advantageously able to allow the emission of the volume of exhaled air and the intake of the inhaled flow of ambient air.

Alternatively, the adjustment element comprises a container adapted to contain the volume of air exhaled by the user and a valve adapted to adjust the intake of the flow of ambient air into the conduit during inhalation as a function of the first plurality of signals. In particular, the valve is alternately configurable in any intermediate condition between the closed condition and the open condition in order to vary the quantity of ambient air to be mixed with the volume of air collected in the container during exhalation of the user.

Preferably, the medical device comprises a Y-shaped auxiliary conduit wherein a first opening is placed in fluid connection with the recirculation opening, a second opening is placed in fluid connection with the container, and a third opening is placed in fluid connection with the valve.

For the purpose of carrying out a predetermined breathing exercise, it is necessary to define a constant volume of air to be exhaled and inhaled by the user. In this case, a valve and a container are advantageously installed at the recirculation opening, by means of a Y- shaped auxiliary conduit. The container has a predetermined volumetric capacity, whereby it is able to collect the volume of exhaled air, whilst the valve is configured to allow the intake of a flow of ambient air during the inhalation phase in order to maintain a constant ratio between the oxygen and carbon dioxide that the user breathes in. In the absence of such a valve, in fact, the quantity of oxygen collected in the container would decrease upon every subsequent exhalation by the user.

According to one aspect of the invention, the container is made of elastic material so as to expand or shrink, respectively, during the exhalation of the volume of air or inhalation of the flow of ambient air.

Advantageously, when not in use, the container will occupy a minimum volume, whereas, when in use, the elasticity of the container will allow the storage of a variable volume of air, which will depend on a large number of different parameters of the user.

According to another aspect of the invention, the medical device comprises a box-like body configured to at least partly contain the conduit and the control unit.

Preferably, the main body comprises a handle to facilitate the manageability of the medical device.

The box-like body is made of rigid plastic material and is shaped in such a way as to contain within it the control unit, the valve, the first detection members and at least a part of the conduit in order to provide protection to such components and be more easily transportable by the user. Even more advantageously, the handle of the box-like body makes it easier for the user to support the medical device during the exercise session.

According to one aspect of the invention, the medical device comprises a mouthpiece arranged at said ventilation opening in order to facilitate the exhalation of the volume of air or the inhalation of the flow of ambient air.

Advantageously, the mouthpiece is similar to the one used for scuba diving masks to facilitate use of the conduit by the user.

According to another aspect of the invention, the control unit comprises a data processing module configured to correlate at least some signals of said first plurality of signals with at least some signals of the second plurality of signals to obtain derived signals.

In this manner, it is possible to correlate the information recorded by the first detection members, i.e. the respiratory values, with those recorded by the second detection members, i.e. the postural values. Advantageously, therefore, it is possible to perform a crosscheck between respiratory characteristics (such as minute ventilation and heart rate) and the execution of breathing (such as chest expansion or abdominal expansion) in order to understand in what way it might be possible to optimise breathing and improve the subject’s posture.

Preferably, the medical device comprises an interface member configured to provide the user with said first plurality of signals, the second plurality of signals and the derived signals.

Advantageously, the interface member allows the user himself to monitor the plurality of respiratory parameters and postural parameters recorded with the first and the second plurality of signals detected, respectively, by the first and the second detection members. Even more preferably, the control unit comprises a transmission module connected with said interface member and configured to send the first plurality of signals, the second plurality of signals and the derived signals in real time to the interface member in order to optimize, in real time and simultaneously, the user's respiratory function and posture during the inhalation and exhalation of the flow of air.

Advantageously, in this manner the user will be able to monitor his posture and his respiratory function in real time and, if necessary, make the necessary corrections in order to be able to improve and render more effective the exercise of his respiratory functions.

According to one aspect of the invention, a non-therapeutic method for monitoring and collecting data on a user’s respiratory functions comprises the operating steps of:

preparing a medical device for the exercise of respiratory functions as previously described;

applying the second detection members on the user’s body areas of interest;

calibrating the medical device;

exhaling a predetermined flow of air through the conduit;

inhaling a flow of ambient air through the recirculation opening ; detecting the first plurality of signals and the second plurality of signals;

repeating of the steps of exhaling the volume of air, inhaling the flow of ambient air and detecting the first plurality of signals and the second plurality of signals.

Preferably, the step of detecting the first plurality of signals and the second plurality of signals occurs simultaneously with the step of exhaling the volume of air and simultaneously with the step of inhaling the flow of ambient air.

Even more preferably, the method comprises a further operating step of displaying the first plurality of signals, the second plurality of signals and the derived signals in order to optimize, in real time and simultaneously, the user’s respiratory function and posture during the subsequent repetitions of exhaling the volume of air and inhaling the flow of ambient air.

Advantageously, the real-time display of the signals detected with the medical device enables the user to monitor his exercise, breathing capacity and posture, so as to be able to instantly correct, as needed, any postural or respiratory errors.

According to one aspect of the invention, the step of calibrating the medical device comprises the sub-steps of:

exhaling a predetermined volume of air through the conduit;

inhaling the volume of air from the container through the conduit; and

repeating the sub-step of exhaling the flow of air and the sub-step of inhaling the volume of air at least four times.

In order to carry out the step of calibrating the medical device, the user remains in an erect position and carries out four complete breathing cycles (i.e. of inhalation and exhalation) inside the conduit. In the case of particular subjects or particular sports activities, the calibration can advantageously also be performed from a seated position. Advantageously, this step determines the contribution of the rib cage relative to the contribution of the abdomen during breathing and the relationships with the postural system, since these correlations are not universal, but rather vary from user to user.

Brief description of the drawings

Additional features and advantages of the present invention will emerge more clearly from the approximate and thus non-limiting description of a preferred, but non-exclusive, embodiment of a medical device for the exercise of a user’s respiratory functions, as illustrated in the accompanying drawings, in which:

- figure 1 illustrates a schematic view of a first embodiment of the medical device for the exercise of respiratory functions in question;

- figure 2 illustrates a schematic view of a second embodiment of the first component of the medical device for the exercise of respiratory functions in question.

With reference to the drawings, they serve solely to illustrate embodiments of the invention in order to better clarify, in combination with the description, the inventive principles at the basis of the invention.

Description of an embodiment

Any modifications or variants which, in the light of the description, are evident to the person skilled in the art, must be considered to fall within the scope of protection established by the present invention, according to considerations of technical equivalence.

Figure 1 illustrates a medical device 1 for the exercise of a user’s respiratory functions, which comprises a first component that may be handled by the user and a second component applicable on the user himself. In greater detail, the medical device 1 comprises a conduit 2, first detection members 3 (which may be seen in figure 2), second detection members 4, an adjustment element 5 and a control unit 6.

The conduit 2 extends between a ventilation opening 7 which the user can use to inhale and exhale a predetermined volume of air V, and an air recirculation opening 8 in fluid connection with the ambient air from which to inhale or exhale at least part of the volume of air V. In other words, therefore, the conduit 2 is configured to convey a volume of air V exhaled or inhaled by the user. Arranged inside the conduit 2 there are first detection members 3 configured to detect, from the volume of air V, a first plurality of signals representative of the respiratory function values. In detail, the first detection members 3 comprise a plurality of detectors of varying type configured to record different respiratory values, including for example the level of carbon dioxide present, the minute ventilation, the oxygen saturation, the force of inhalation and exhalation, the airflow rate and the respiratory rate.

During inhalation of the user, as a function of the first plurality of signals detected by the first detection members 3, the adjustment element 5 associated with the recirculation opening 8 is configured to adjust the intake of a flow of ambient air F into the conduit 2. In detail, the adjustment element 5 is alternately configurable in any intermediate condition between a closed condition, wherein the passage of the flow of ambient air F is completely disabled, and an open condition, wherein the passage of the flow of ambient air F is completely enabled. Consequently, in any intermediate condition, the adjustment element 5 allows a partial introduction of the flow of ambient air F.

Generally, as a result of intense or long-lasting muscle exertion, the body tends to increase its ventilation by carrying out deeper and faster breaths in order to compensate for the higher oxygen demand. In this situation, the user is in the so-called condition of hyperpnea. In contrast, an increase in the rate and depth of breathing without there being any actual demand of the body determines a greater ventilation than is required, bring the user into the so-called condition of hyperventilation.

Advantageously, the medical device 1 is configured to enable a user to increase the rate and depth of breathing without any fatiguing muscle work having been performed. Therefore, the device 1 is advantageously capable of training the respiratory muscles without giving rise to hyperventilation, since the adjustment element 5, when appropriately set (i.e. when configured in the correct intermediate condition between the closed condition and the open one), enables the physiological ratio between the oxygen and carbon dioxide required by the body to be maintained constant.

In other words, the adjustment element 5 is configured to enable the user to inhale again only a part of the air previously exhaled (richer in carbon dioxide than the ambient air), since, during the new phase of inhaling, part of the volume inhaled is the flow of ambient air coming from the outside environment (richer in oxygen than the exhaled air).

Even more advantageously, as better illustrated below in the present description, said appropriate setting of the adjustment element 5 is carried out by means of the control unit 6 following the detection of the first and second pluralities of signals representing respiratory and postural parameters of the user by the first and second detection members 3, 4, respectively.

In addition, as better illustrated below, the device 1 comprises a shirt that can be worn and positioned in which there are the second detection members 4 for detecting the postural parameters of the user, mainly during the inhalation and exhalation phases, including information on the position and movement of the shoulders, the chest and the spine. The shirt provided with the second detection members 4 has the purpose of improving the respiratory and postural functions at the same time, since an improvement in the posture of the torso, the shoulders and the spine determines a consequent and advantageous improvement in respiratory function.

The device 1 , therefore, in addition to recording the respiratory rate, is advantageously configured to record other parameters related to the force of exhalation and inhalation through the volume of air breathed out and in by the user and the maximum exhalation volume measured per second. In this manner, the device 1 enables both the exhalation time of the user to be trained, and the inhalation and exhalation muscles to be trained, thereby improving strength and resistance. In fact, based on the feedback information detected by means of the control unit 6 and shown to the user by means of an external interface member, one is able to modulate the respiratory rate (inhalation and exhalation) and the breathing intensity, i.e. how much force is necessary for inhalation and exhalation.

In addition, thanks also to the advantageous viewing, in real time or in recorded form, of the postural information detected by the second detection members 4 arranged inside the shirt, it is possible to modify the proprioceptive-postural response during the phases of inhalation and exhalation of the user.

According to a first embodiment of the invention, the adjustment element 5 comprises an air filter adapted to allow the emission of the volume of air V into the ambient air and to adjust the intake of the flow of ambient air F into the conduit 2 during inhalation of the user as a function of the first plurality of detected signals.

Alternatively, a second embodiment of the invention illustrated in figure 2 envisages that the adjustment element comprises a container 1 1 adapted to contain the volume of air V exhaled by the user and a valve 12 adapted to adjust the intake of the flow of ambient air F into the conduit 2 during inhalation of the user, as a function of the first plurality of detected signals. In particular, the valve 12 is alternately configurable in any intermediate condition between the closed condition and the open condition.

The container 1 1 is configured to contain a predetermined volume of air V exhaled by the user during the respiratory function exercise session, i.e. during the training to improve lung capacity.

Preferably, the container 1 1 is a bag made of elastic material, such as, for example, silicone or rubber, and having a predetermined capacity for containing the aforesaid volume of air V. The exhalation of air by the user induces an extension of the container 1 1 until it contains the aforesaid volume of air V, whereas inhalation determine the shrinkage thereof to the initial rest dimensions, wherein the overall dimensions are minimum, as a consequence of the removal of air. More precisely, the capacity of the container 1 1 is predetermined and is selected according to the user who will undergo the respiratory function exercise session, as will be better explained below. Consequently, the container 1 1 is interchangeable with other containers having different capacities in the event that the user of the medical device 1 changes.

Every respiratory function exercise session entails, on the user’s part, the continuous repetition, without pauses, of an exhalation of air and a subsequent inhalation of air. However, inhalation of a volume of air V previously exhaled determines the reabsorption of a higher and higher level of carbon dioxide at the cost of a lower and lower level of oxygen; however, the latter is necessary for blood oxygenation and for survival. Therefore, the valve 12 is essential if the container 1 1 is present, since its main purpose is to introduce a flow of ambient air F during the phase of inhalation of the user so as to maintain the ratio between oxygen and carbon dioxide constant. Consequently, as a function of the level of carbon dioxide recorded by the respective detector, the valve 12 adjusts the insufflation of ambient air, richer in oxygen than the volume of air V present in the container 1 1. For example, as the level of carbon dioxide recorded in the volume of air V inhaled from the container 1 1 increases, the valve 12 is configured to increase the inflow of ambient air from outside the medical device 1 to increase the oxygen concentration.

According to one aspect of the invention, the medical device 1 comprises a Y-shaped auxiliary conduit wherein a first opening is placed in fluid connection with the recirculation opening 8, a second opening is placed in fluid connection with the container 1 1 , and a third opening is placed in fluid connection with the valve 12.

Alternatively, the conduit 2 and the auxiliary conduit are made in one piece.

According to one aspect of the invention illustrated in figure 2, a mouthpiece 17 is arranged at the ventilation opening 7 and is shaped so as to facilitate the user’s inhalation or exhalation of air through the conduit 2. The mouthpiece 17 is made of silicone with a conformation similar to that of a scuba diving mouthpiece 17 in order to provide a solid grip between the teeth to the user, who must insufflate the totality of the air contained in his lungs through the conduit 2, not dispersing it into the environment before it has passed through the conduit 2 itself.

Alternatively, according to a different aspect of the invention, at the ventilation opening 7 of the conduit 2 an oronasal mask (not illustrated) is installed which may be comfortably worn by the user to carry out the training session. The use of the mask allows the nasal airways to be kept free during the exercise, since, thanks to the mask itself, any partial exhalation from the nose is in any case conveyed through the conduit 2.

The second detection members 4 are operatively applicable to specific body areas of the user, including the sternal area, the shoulders and the spine, to detect a second plurality of signals representing the respiratory and postural parameters of the user himself, including heart rate, the phase angle, the range of movement of the abdominal wall and the range of movement of the rib cage. In addition, it is also possible to place the second detection members 4 in contact with the abdominal fascia and/or sub-axillary fascia of the user, as a function of the type of parameters one intends to record. In other words, it is possible to apply the second detection members 4 to different and variable body portions of the user.

According to an advantageous aspect of the invention, the second detection members 4 comprise a shirt 18 that can be worn by the user and a plurality of sensors 19 connected to the shirt 18.

Advantageously, the use of the shirt wherein the second detection members 4 are provided enables the user to use a totally portable and manageable device 1 that does not need to be connected directly (for example by electric cables) to laboratory machinery, generally more cumbersome and limiting in movements. The shirt 18 is made of a light, breathable material and is easy to wear. The sensors 19, among which oscillometers and gyroscopes are used, are configured to detect the movement, direction and speed of movement of postural muscles. Advantageously, the sensors 19 are applied to the shirt 18 by means of Velcro or a similar material, in order that they can be removed to wash the shirt 18 or moved easily to other points of interest. Alternatively, the shirt 18 is made of an elastic material endowed with piezoelectric properties such as to record the variation of the abdominal and/or chest extension of the user during his respiratory and postural exercise.

In addition, the use of the shirt 18, in which the sensors 19 are positioned beforehand, enables the latter to be positioned with a single action in the specific zones adherent to the body area that must be analysed, more precisely, the anterior apex of the shoulders, the spine in three points (at the vertebrae “T3”-“T7”-“T12”), the lumbar spine (“L2”- “L3”), the sternum (manubrium-body) and the abdomen. Furthermore, temperature and heart rate sensors are present. In particular, the sensors that the postural monitoring system, i.e. the aforesaid shirt 18, will be provided with will enable specific corrections of the user’s proprioceptive- postural system.

According to one aspect of the invention, the control unit 6 is connected to the adjustment element 5, the first detection members 3 and the second detection members 4 so as to receive the first plurality of detected signals and the second plurality of detected signals.

Preferably, the connections with the control unit 6 take place via wireless or Bluetooth technology, but a possible connection can also be made physically with specific cables for the transmission of electrical signals.

As a function of the first plurality of detected signals, the control unit 6 is advantageously configured to move the adjustment element 5 between the open condition and the closed condition. If the medical device 1 comprises the container 11 , the valve 12 connected to the control unit 6 can be moved by the latter into any condition comprised between the open condition and the closed condition in order to maintain the oxygen/carbon dioxide ratio constant during the phase of inhalation of the user.

Even more advantageously, the control unit 6 comprises a receiving module to which the second detection members 4 are configured to send the second plurality of detected signals.

According to one aspect of the invention, the control unit 6 comprises a data processing module configured to correlate at least some signals of the first plurality of signals with at least some signals of said second plurality of signals to obtain significant derived signals characteristic of the user of the medical device 1 , in order to develop the exercise that is suitable for improving respiratory and postural functions.

In addition, the medical device 1 comprises an interface member 22 that advantageously makes the signals detected by the sensors 19 and the detectors and encoded by the data processing module available to the user. For this purpose, the medical device 1 comprises a control panel capable of notifying the user of the progression of his exercise session in an audible and/or visual and/or tactile manner. The control panel, for example, can have a plurality of LED indicators or liquid crystal displays that can turn on or off to show the variation of the levels of carbon dioxide, or the heart and/or respiratory rate.

Preferably, the control panel is a touchscreen display or a tablet wherein it is possible to view the force-velocity graph in the various inhalation and exhalation phases, the respiratory rate, the movements of the torso or the body segment analysed on the sagittal and frontal plane. In addition, a“Postural-Smart-Index”, i.e. a dot graph of the movement in space of the postural sensors, can appear on the touchscreen display. Advantageously, the user or whoever is enabled to set, on his behalf, which “Postural-Smart-Indexes” will be made to appear on the screen according to the user’s postural and/or motor situation. Furthermore, the different types of resting position (standing on one foot or two feet and sitting) can be shown on the display and the different possible display modes will enable precise tasks to be assigned during the training session, by breaking down the movement and increasing the work rates, in order to ensure that the stimulus administered is actually effective in reprogramming the visual-proprioceptive control systems. In addition, for example, the rate can be pre-set and modified during the exercise session directly via the touchscreen display. Even more advantageously, all of the data can be displayed and uploaded to a specific application or specific software of an operating system for reference.

Even more preferably, therefore, the control unit 6 comprises a transmission module connected with the interface member 22 and is configured to send the first plurality of signals, the second plurality of signals and the derived signals to the interface member 22 in real time so as to display them instantly, for example on a screen, in order to optimize, in real time and simultaneously, the user’s respiratory function and posture during inhalation of the flow of ambient air F and the exhalation of the volume of air V.

According to one embodiment of the invention, the medical device 1 comprises a box-like body 24 configured to at least partly contain the conduit 2, the first detection members 3 and the control unit 6. Advantageously, therefore, the box-like body 24 collects together the components of the medical device 1 so as to reduce the total dimensions thereof and keep it firmly in position.

Preferably, the box-like body 24 comprises a handle 25 to facilitate the manageability of the medical device 1. The handle 25 offers the user a support of the medical device 1 during the exercise. Advantageously, furthermore, the handle 25 is shaped in such a way that any display connected to the box-like body 24 is kept turned towards the user’s face to facilitate monitoring of the respiratory and postural parameters in every instant. According to one aspect of the invention, the conduit 2 is composed of a main conduit, wherein the recirculation opening 8 is present, and a secondary conduit, wherein the ventilation opening 7 is present.

In this manner, it is advantageously possible to insert the conduit 2 at least partly inside the box-like body 24, rather than assembling the latter (wherein the first detection members are contained 3) around the conduit 2. In other words, the main conduit is inserted through the box-like body 24 via a specific through cavity fashioned in the latter so that the recirculation opening 8 remains projecting outwards and a first connection opening for connecting with the secondary conduit remains positioned inside the box-like body 24. Consequently, the secondary conduit is inserted into the box-like body 24 so that a second connection opening for connecting with the main conduit is coupled with the first connection opening and the ventilation opening 7 remains projecting outwards so as to be used by the user.

As regards an example of the operation of the medical device 1 , it derives directly from what has been described above and will be illustrated below.

Once the medical device has been set up and the mouthpiece placed in the mouth, the user begins to breathe by blowing (the exhalation phase) into the mouthpiece so that a volume of air dependent on the user’s lung capacity flows through the conduit into the container, if the latter is present. Advantageously, the quantity and quality of the air flowing through the conduit is defined by one or more sensors, one of which is sensitive to the level of carbon dioxide. At that point, there follows the inhalation phase, so that a flow of air is breathed in by the user. If the container is present, the flow breathed in comes at least in part from the container itself and in the event that the level of carbon dioxide recorded is excessive (and thus potentially dangerous), the adjustment element present at the end of the conduit is configured to allow the inhalation of a predetermined flow of ambient air, richer in oxygen. Advantageously, such use of the medical device makes it possible to increase the respiratory rate, the flow resistance and the volume of air breathed in, by modulating different types of exertion, while the concentration of carbon dioxide remains more or less constant. Accordingly, via this method of isocapnic hyperpnea it is possible to increase the activation of the respiratory muscles.

The sensors provided will be capable of recording the flow of air breathed in, the total volume and the volume of every individual breath, the force of the flow of exhaled and inhaled air and the concentration of oxygen and carbon dioxide.

The medical device further comprises a shirt fitted with sensors capable of detecting the movement of the rib cage and spinal posture during the exhalation and inhalation phases.

The data thus collected will be processed by specific software and uploaded to a specific device for the display of information on posture during breathing, to provide an analysis of the spinal posture before and after the exercise, and to provide an assessment of the quantity and quality of each breath and of the efficiency of the exercise performed.

Claims

1. A medical device (1 ) for the exercise of a user's respiratory functions, comprising:

a conduit (2) extending between a ventilation opening (7) which the user can use to inhale and exhale a predetermined volume of air (V), and an air recirculation opening (8) in fluid connection with the ambient air from which to inhale or exhale at least part of the volume of air (V);

first detection members (3) arranged inside said conduit (2) and configured to detect, from said volume of air (V), a first plurality of signals representing the respiratory function values;

an adjustment element (5) associated with said recirculation opening (8) for adjusting the intake of a flow of ambient air (F) into said conduit (2) during inhalation as a function of the first plurality of signals detected by said first detection members (3); said adjustment element (5) being alternately configurable in any intermediate condition between a closed condition, wherein the passage of the flow of ambient air (F) is disabled, and an open condition, wherein the passage of the flow of ambient air (F) is enabled;

a control unit (6) connected to said adjustment element (5) and said first detection members (3) for receiving said first plurality of detected signals; said control unit (6) being configured to move said adjustment element (5) between said open condition and said closed condition as a function of said first plurality of detected signals;

characterized in that it comprises second detection members (4) operatively applicable to specific body areas of the user, including the sternal area, the shoulders and the spine, to detect a second plurality of signals representing the respiratory and postural parameters of the user himself; said second detection members (4) being configured to send said second plurality of detected signals to a receiving module of said control unit (6);

wherein said second detection members (4) comprise a shirt (18) that can be worn by the user and a plurality of sensors (19) connected to said shirt (18) and configured to detect said second plurality of signals.

2. The medical device (1 ) according to claim 1 , wherein said adjustment element (5) comprises an air filter adapted to allow the emission of said volume of air (V) into the ambient air and to adjust the intake of said flow of ambient air (F) into said conduit (2) during inhalation as a function of the first plurality of signals.

3. The medical device (1 ) according to claim 1 , wherein said adjustment element (5) comprises a container (1 1 ) adapted to contain said volume of air (V) exhaled by the user and a valve (12) adapted to adjust the intake of said flow of ambient air (F) into said conduit (2) during inhalation as a function of the first plurality of signals; said valve (12) being alternately configurable in any intermediate condition between said closed condition and said open condition.

4. The medical device (1 ) according to claim 3, comprising a Y-shaped auxiliary conduit wherein a first opening is placed in fluid connection with said recirculation opening (8), a second opening is placed in fluid connection with said container (1 1 ), and a third opening is placed in fluid connection with said valve (12).

5. The medical device (1 ) according to claim 3 or 4, wherein said container (11 ) is made of elastic material so as to expand or shrink, respectively, during the exhalation of said volume of air (V) or inhalation of said flow of ambient air (F).

6. The medical device (1 ) according to any one of the preceding claims, comprising a box-like body (24) configured to at least partly contain said conduit (2) and said control unit (6).

7. The medical device (1 ) according to claim 6, wherein said box-like body (24) comprises a handle (25) to facilitate the manageability of said medical device (1 ) in use.

8. The medical device (1 ) according to any one of the preceding claims, comprising a mouthpiece (17) arranged at said ventilation opening (7) in order to facilitate the exhalation of said volume of air (V) or the inhalation of said flow of ambient air (F).

9. The medical device (1 ) according to any one of the preceding claims, wherein said control unit (6) comprises a data processing module configured to correlate at least some signals of said first plurality of signals with at least some signals of said second plurality of signals to obtain derived signals.

10. The medical device (1 ) according to claim 9, comprising an interface member (22) configured to provide the user with said first plurality of signals, said second plurality of signals and said derived signals.

11. The medical device (1 ) according to claim 10, wherein said control unit (6) comprising a transmission module connected with said interface member (22) and configured to send said first plurality of signals, said second plurality of signals and said derived signals in real time to said interface member (22) to display them in order to optimize, in real time and simultaneously, the user's respiratory function and posture during the exhalation of said volume of air (V) or the inhalation of said flow of ambient air (F).

12. A non-therapeutic method for monitoring and collecting data on a user's respiratory functions, comprising the operating steps of:

preparing a medical device (1 ) for the exercise of a user's respiratory functions according to any one of claims 1 to 1 1 ;

applying said second detection members (4) to the user's body areas of interest;

calibrating said medical device (1 );

exhaling a predetermined volume of air (F) through said conduit (2); inhaling a flow of ambient air (F) through said recirculation opening

(8) and said conduit (2);

detecting said first plurality of signals and said second plurality of signals; repeating the steps of exhaling said volume of air (V), inhaling said flow of ambient air (F) and detecting said first plurality of signals and said second plurality of signals.

13. The method according to claim 12, wherein said step of detecting said first plurality of signals and said second plurality of signals occurs simultaneously with said step of exhaling a volume of air (V) and said step of inhaling said flow of ambient air (F).

14. The method according to claim 12 or 13 when dependent on claim 10 or 1 1 , comprising a further operating step of displaying said first plurality of signals, said second plurality of signals and said derived signals to optimize, in real time and simultaneously, the user's respiratory function and posture during subsequent repetitions of exhaling the volume of air (V) and inhaling the flow of ambient air (F).

15. The method according to any one of claims 12 to 14, wherein said step of calibrating said medical device (1 ) comprises the sub-steps of: exhaling a volume of air (V) through said conduit (2) until reaching said predetermined volume of air (V);

inhaling said flow of ambient air (F) through said conduit (2);

repeating said sub-step of exhaling a volume of air (V) and said sub-step of inhaling said flow of ambient air (F) at least four times.