WO2022079393A1

WO2022079393A1 - Device designed to be fitted to a respiratory mask and to collect respiratory data from the wearer

Info

Publication number: WO2022079393A1
Application number: PCT/FR2021/051791
Authority: WO
Inventors: Eric Champion; Simon POLETTE; Francis Cannard
Original assignee: Texisense
Priority date: 2020-10-14
Filing date: 2021-10-14
Publication date: 2022-04-21
Also published as: FR3114958B1; FR3114958A1

Abstract

The invention relates to a device (10) designed to be fitted to a respiratory mask and to collect respiratory data from the wearer, said device (10) comprising: an acquisition system (20) including a pressure sensor (21); a data transmission system (30); and a power source (40); characterised in that the device (10) forms a one-piece module.

Description

DEVICE DESIGNED TO FIT A RESPIRATORY MASK AND COLLECT RESPIRATORY DATA OF A WEARER

Technical area

The invention relates to the technical field of equipment for monitoring the respiratory characteristics of a person.

Prior art

The Covid crisis has required the generalization of the use of respiratory masks in the population. The mask is a major means of prevention against the spread of the virus. Two main categories of masks have been used by the general public, namely surgical masks and textile masks.

In the context of respiratory diseases of all kinds, the Applicant has sought to instrument these masks in order to evaluate and detect in the wearer, anomalies associated with his respiratory function.

WO2016157159 describes an example of an instrumented mask, comprising a data acquisition system. However, such a mask is intended for medical or industrial use, not for consumer use. The waterproof mask is equipped with a controllable outlet valve to promote the escape of exhaled air. This is radically different from the principle of respiratory masks designed to prevent the spread of viruses by air.

CN205432239 and CN106606357 describe instrumented textile masks which evaluate breathing through temperature sensors.

Disclosure of Invention

The object of the invention is to provide a solution for collecting respiratory data, potentially over a long period of time, without the need to stay in a medical establishment.

To this end, the invention relates to a device designed to equip a respiratory mask and collect the respiratory data of a wearer, the device comprising: an acquisition system including a pressure sensor; a data transmission system; and a power source.

According to the invention, the device constitutes a one-piece module.

Thus, the device is compact, easy to handle and suitable for integration into different masks. The device can be easily integrated into all types of commercial masks, such as surgical masks, textile masks, or artificial respirator masks. The device is versatile and compatible with a large number of masks.

The data is transmitted to a recording and analysis device, for example a telephone, a computer, a tablet, a watch, or any other device, controlled by the wearer, a doctor, or any other person, depending on the intended application. The device makes it possible to characterize the wearer's breathing parameters:

- Phases of temporary depression caused by inspiration.

- Temporary overpressure phrases caused by exhalation.

- Respiratory rate.

- Flow rate and volume of inspired and expired air.

- Respiratory abnormalities.

According to other advantageous characteristics of the device according to the invention, taken in isolation or in combination:

- The pressure sensor is of the barometric type.

- The transmission system works by ultra high frequency radio waves, preferably of the "Bluetooth Low Energy" type (in French: "low energy").

- The power source includes one or more button cell batteries.

- The module has a thickness less than or equal to 10 mm, a width less than or equal to 30 mm, and a length less than or equal to 30 mm.

- According to a particular embodiment, the module has a thickness less than or equal to 5 mm, a width less than or equal to 10 mm, and a length less than or equal to 15 mm.

- The device comprises an electronic card on which are mounted the pressure sensor, the transmission system and the energy source.

- The acquisition system includes a temperature sensor designed to measure the temperature of the air inside the mask.

- The acquisition system includes an accelerometer designed to record the movements of the device.

- The device includes means for temporary fixation in the mask. These temporary fixing means can be of different types: a lapel pin ("pin's"), a brooch, a Velcro®, an adhesive, or any other suitable means.

- The device comprises permanent attachment means in the mask. These permanent fastening means can be of different types: riveting, sewing, gluing, or any other suitable means.

The invention also relates to an instrumented mask, comprising: an envelope provided to be positioned on the wearer's face; and a system for attaching the cover to the wearer's head; characterized in that the mask comprises a device as described above.

According to other advantageous characteristics of the mask according to the invention, taken in isolation or in combination:

- The envelope has an anatomical shape adapting to the morphology of the face by limiting air leaks and creating a respiratory pocket between its internal surface and the wearer's face.

- The attachment system is designed to ensure a firm and comfortable hold for the mask, which limits the risk of incorrect positioning or the mask slipping on the face.

- The envelope has a pocket designed to receive the device.

- The envelope includes means for temporarily fixing the device in the mask. These temporary fastening means can be of different types: an open pocket, a lapel pin ("pin's"); a pin, a Velcro®, an adhesive; or any other suitable means.

- The envelope includes means for permanently fixing the device in the mask. These permanent fastening means can be of different types: a closed pocket, riveting, a seam, a collage; or any other suitable means.

- The pressure sensor is positioned in the mask halfway between the position of the nose and the position of the mouth.

- The envelope is made of textile material.

- The envelope is made of plastic or composite materials.

- The mask has no exhalation valve.

Brief description of the drawings

The invention will be better understood on reading the following description, given solely by way of non-limiting example and made with reference to the appended drawings in which:

[Fig.l] Figure 1 is a side view of a breathing mask according to the invention, folded in half.

[Fig.2] Figure 2 is a view of the inside of the mask.

[Fig.3] Figure 3 is a front view of the mask.

[Fig.4] Figure 4 is a front view of the device according to the invention.

[Fig.5] Figure 5 is a rear view of the device.

[Fig.6] Figure 6 is a graph showing an example of measurement of the raw data recorded inside the mask.

[Fig.7] Figure 7 is a graph showing another measurement example.

[Fig.8] Figure 8 is a graph showing an interval of Figure 7, on a larger scale.

[Fig.9] Figure 9 is a graph equivalent to Figure 7, with the addition of the atmospheric pressure measurement.

[Fig.10] Figure 10 is a graph showing the data of Figure 9, having received a first signal processing.

[Fig.11] Figure 11 is a graph showing the data of Figure 10, having received a second signal processing.

[Fig.12] Figure 12 is an illustration of devices according to the invention, tropicalized or not.

[Fig.13] Figure 13 is a device according to the invention protected by a housing.

[Fig.14] Figure 14 is another illustration of the device of Figure 13.

[Fig.15] Figure 15 is a diagram illustrating the mounting of the device of Figure 13 on a disposable mask.

[Fig.16] Figure 16 is an illustration of the device of Figure 13 mounted on a disposable mask.

[Fig.17] Figure 17 is another illustration of the device of Figure 13 mounted on a disposable mask. [Fig.18] Figure 18 is another illustration of the device of Figure 13 mounted on a disposable mask.

[Fig.19] Figure 19 is a diagram illustrating the mounting of a device according to the invention on a reusable mask.

Detailed description of the invention

In Figures 1 to 3 is shown an instrumented respiratory mask (1) according to the invention, equipped with an electronic device (10) designed for collecting respiratory data from a wearer (2).

The mask (1) is designed to prevent the spread of viruses by air, of the flu or covid type. The mask (1) could be of another type, different from a sanitary mask, depending on the intended application.

The mask (1) comprises an envelope (3) intended to be positioned on the face of the wearer (2); and a system (4) for attaching the envelope (3) to the wearer's head (2). The envelope (3) is in the form of a band of material intended to be positioned in front of the face of the wearer (2), covering the nose and the mouth. The envelope (3) can be made of textile material or of other materials, for example plastics or composites. The attachment system (4) comprises two lateral straps designed to be attached to the ears, or to pass behind the head, or any other suitable means.

Advantageously, the envelope (3) is designed with an anatomical shape adapting to the morphology of the face by limiting air leaks and creates a respiratory pocket between its internal surface and the face of the wearer (2).

Also advantageously, the attachment system (4) allows a firm and comfortable hold of the mask (1), which limits the risks of bad positioning or of the mask (1) sliding on the face (the effect of which would be to create air leaks)

The device (10) is integrated into the mask (1) in FIGS. 1 to 3, and arranged outside the mask (1) in FIGS. 4 and 5. The device (10) comprises an acquisition system (20) including a pressure sensor (21), a data transmission system (30), and a power source (40). The device (10) comprises an electronic card (50) on which the pressure sensor (21), the transmission system (30) and the energy source (40) are mounted.

According to the invention, the device (10) constitutes a one-piece module, compact and easy to handle, which can be integrated into different types of masks (1) on the market, such as surgical masks, textile masks, or respirator masks artificial.

The module is contained in a parallelepiped having a thickness less than or equal to 10 mm, a width less than or equal to 30 mm, and a length less than or equal to 30 mm. The first version of the module has a thickness of 6 mm, a width of 25 mm and a length of 26 mm. The second version in development is 5mm thick, 10mm wide and 15mm long. As the device (10) is small in size, it can be easily integrated into different types of masks (1), removably, to add a pressure measurement function to the original functions of these masks (1).

The module may comprise a protective and insulating coating, for example a resin molding, a varnish deposit, a foam, or any other type of coating. As an alternative or in addition, the module can be arranged in a casing. Preferably, the housing is made of plastic. At a minimum, the module is tropicalized, that is to say provided with electrical insulation. Preferably, the module is also provided with mechanical protection, against shocks and to restrict access to the batteries.

FIG. 12 illustrates a first acquisition system (20) corresponding to the invention, and comprising a pressure sensor (21), as well as a second tropicalized acquisition system (20'), and comprising a pressure sensor (21). It can be seen that the tropicalization of the second acquisition system (20') consisted, in this case, in applying a protective varnish to the surface of the acquisition system (20'). Of course, the pressure sensor (21) is not blocked by the protective varnish so as not to hinder its measurements.

Figure 13 illustrates a device (10) contained in a protective casing (60). In order to allow exchanges with the air breathed inside the mask (1) and the pressure sensor (21), the protective casing (60) has only one opening (61) arranged facing said sensor ( 21). Preferably, this opening (61) is arranged at the level of a boss (62).

Referring to Figure 14, the protective casing (60) is preferably in two parts (60a, 60b) in order to allow its opening in order to change and/or recharge the energy supply means (40).

Referring to Figures 15 to 17, the device (10) is mounted on a pre-existing disposable mask (1), that is to say a commercially available disposable mask already approved, among other things in terms of adjustment capabilities on the face of the wearer (2), in terms of the level of residual air leaks at the interface between the mask (1) and the face of the wearer (2), or even in terms of compatibility of the materials constituting the mask (1) with the wearer's skin (2).

In these figures, the device (10) is mounted on the pre-existing mask (1) by simple gluing, using any glue or adhesive suitable for this purpose. It suffices to simply pierce the casing (3) according to a diameter corresponding to that of the opening (61), or to that of the boss (62) if the housing (60) is provided with one. The use of the boss (62) makes it possible to prevent the opening (61) from being aligned with the hole made in the casing (3). By inserting the boss (62) into the bore of the casing (3), the correct positioning of the opening (61) and therefore the correct operation of the pressure sensor (21) is ensured. In this case, the boss (62) has an outer diameter of the order of 2 to 5mm, for example 3mm. Indeed, an opening (61) that is too small leads to a latency in the measurement of the pressure variation.

Figures 16 and 17 are representations of the device (10) shown schematically in Figure 15. In this embodiment:

- the acquisition system (20) is tropicalized;

- the pressure sensor (21) protrudes relative to the tropicalization varnish;

- the protection of the acquisition system (20) is reinforced by the presence of a box (60); - the housing (60) is glued to the outer face of a pre-existing mask (1) on which it was sufficient to drill a hole for the passage of the boss (62).

In a medical context, placing the device (10) outside the mask (1) has several advantages:

- this avoids any risk of swallowing, particularly if the patient is unconscious;

- in the case of a patient under respiratory assistance with a supply of dioxygen, this makes it possible to limit the risk of burns which may occur if the dioxygen is in the presence of a spark;

- finally, the equipped mask (1) being already certified, the additional constraints in terms of vigilance material or compatibility for contact with the skin are limited.

Figure 19 illustrates another embodiment, suitable for mounting on a reusable pre-existing mask (1). The lifetime of this reusable mask (1) being greater, it is judicious to be able to disassemble the device (10) from the mask (1). The same patient can have at his disposal several masks (1), and organize a rotation between masks (1) used and soiled, and masks (1) washed and clean which are reusable. The patient can then remove the device (10) from the soiled mask (1) and put it back on a clean mask (1).

The advantage of having a removable device (10) is not limited only to reusable masks, and is also relevant in the case of disposable masks, preferably masks already standardized FFP2 or surgical, for example so that a device (10) whose power supply means (40) are exhausted can be replaced. Or, if the capture of respiratory data from a patient began with a first mask (1), but must be continued with another mask (1), then the device (10) can be removed from the first mask (1) and be assembled on the second mask (1) in order to follow the patient.

The masks (1) can be provided with a support (70), intended to receive the device (10) in a removable manner. The assembly of the device (10) and the support (70) is preferably done at the level of the protective casing (60), for example by snap-fastening complementary shapes (63, 71), as illustrated in FIG. 19. The means assembly can be of different nature, for example by screwing, or by assembly by quarter turn. The support (70) can be placed at the time of manufacture of the mask (1) by automated means without significantly increasing the cost of the mask (1).

In some embodiments, the bracket (70) forms part of the housing (60). For example, in FIG. 15, a first half-box (60a) can be glued to the envelope of the mask (3), preferably during its manufacture. At the time of use of the device (10), the second half-housing (60b) is assembled with the first half-housing (60a) so as to secure the device (10) with the mask (1), and to close the housing (60) protecting the device (10). In this embodiment, the device (10) is preferably tropicalized in order to protect the electronics of the acquisition system (20).

The device (10) is designed to characterize the breathing parameters of the wearer (2): the phases of depression caused by inspiration, the phases of overpressure caused by expiration, the respiratory frequency, the flow rate and the volume of inspired and expired air, respiratory abnormalities. The acquisition system (20) can include different types of sensors, in addition to the pressure sensor (21). These other sensors make it possible to carry out additional physiological measurements to refine and simplify the interpretation of the pressure measurements. The system (20) may include a temperature sensor (22) adapted to measure the temperature of the air inside the envelope of the mask (1).

The system (20) can include an accelerometer (23) designed to record the movements of the device (10), and therefore of the mask (1). The accelerometer (23) can be used to wake up the dormant transmission system (30). Also, the accelerometer can be used to determine an activity level to interpret breathing characteristics. For example, if the respiratory rate increases with the intensity of this activity, we can decide on a normal increase corresponding to an adaptation to the effort. But if the respiratory rate increases without detecting an increase in activity, then the increase in the respiratory rate may be the result of a respiratory problem and require specific action.

The transmission system (30) is configured to transmit the data to one or more recording and analysis devices, for example a telephone, a computer, a tablet, a watch, or any other device. The analysis device executes for example a computer program to process the collected data and to compare them with reference data, and to note a discrepancy between the collected data and the reference data. The deviations can be for example: a sudden variation in the respiratory rate, a variation in the respiratory volume, a combination of these two phenomena, coughing spells, apneas, etc.

The data collected and the discrepancy observed can then be made available to a practitioner so that he can read them and use them to establish a particular clinical picture and deduce a diagnosis therefrom.

The transmission system (30) operates by ultra high frequency radio waves, preferably of the Bluetooth Low Energy type. The ultra high frequency (UHF) band of the radio spectrum is between 300 MHz and 3000 MHz.

The power source (40) includes two button cell batteries. Alternatively, the energy source (40) can be of any type suitable for the intended application. Thanks to the low consumption capacity of the device (10), an autonomy of several weeks can be achieved without having to change or recharge the energy source.

The device (10) and/or the mask (1) can comprise means for fixing the device (10) to the mask (1). Preferably, the mask (1) is provided with a pocket (5) sewn or glued into the envelope (3) and intended to receive the device (10). Still preferably, the pouch (5) has an entry opening (6) arranged on the outside, in order to avoid any risk of the device (10) being swallowed when the mask (1) is positioned on the wearer's face. (2).

The fixing means can be temporary fixing means, of different types: an open pocket (5), a lapel pin ("pin's"), a brooch, a Velcro®, an adhesive, or any other suitable means. The temporary attachment is useful for disposable or washable masks. Also, the temporary attachment is useful for equipping aerosol masks, for example, in order to temporarily add a function for evaluating respiratory capacities.

The fixing means can be permanent fixing means, of different types: a closed pocket (5), riveting, sewing, gluing, or any other suitable means. The device (10) can be integrated into the mask (1) by being fixed directly inside the envelope (3) during its manufacture, for example between the different filtering layers. The permanent attachment is useful for certain types of masks, in particular those intended for children, for which it is imperative to avoid any risk of the device (10) being swallowed.

Whatever the fastening means used, they favor positioning the pressure sensor (21) halfway between the nose and the mouth.

For the device (10) to be adopted on a large scale, several conditions must be met:

- Adaptability to the greatest number of masks used by the general public.

- Possibility of using the structure of textile masks produced by industry without significantly modifying their properties.

- Compatibility with mass distribution constraints.

- Reduced cost to promote its distribution.

- Ease of use: the mask (1) is placed on the face and there is nothing else to do.

- Reliability of measurements that can initiate vital diagnoses for the wearer.

- Wearing comfort without respiratory discomfort, in order to allow wearing for long periods of time (Holter function).

- Appearance of a "usual" mask and in no case that of a gas mask, so that people wear it easily.

- Adaptability to fashion effects to facilitate its acceptance by the greatest number.

- Integration of measurement capacities should not limit the air filtration capacities necessary for the health requirements of wearing a mask.

- Washable in order to allow its reuse in the normal context of use of a protective mask.

- Possibility in some versions to claim medical device status.

The invention also relates to a method for collecting respiratory data. The process includes the following steps:

- The device (10) is integrated in a mask (1).

- The device (10) is connected to an analysis device.

- The data transmitted by the device (10) are processed within the device. The raw data can be transformed into data usable by the wearer (2), a doctor, or another person, depending on the intended application.

- Finally, the respiratory characteristics of the wearer (2) can be studied to propose a diagnosis.

The operation of the device (10) is illustrated in the graphs of FIGS. 6 to 11, comprising the time T on the abscissa and the pressure P in mbar on the ordinate. The envelope (3) of the mask (1) forms a mechanical barrier allowing the filtration of the air. This filtration opposes a resistance to the natural circulation of air and induces a temporary overpressure / depression, functions of the expiratory and inspiratory phases.

The principle of the invention consists in continuously measuring the variations in air pressure inside the mask (1) thanks to the device (10), in order to characterize the respiratory phases (temporary suppressions and depressions relative to the pressure atmospheric).

The graph in Figure 6 shows a recording of pressure variations measured inside a textile mask. The data has been processed to remove variations in atmospheric pressure. The graph shows the expiratory phases (P-Exp), the inspiratory phases (P-Ins), the time interval of a Breath including an Expiration and an Inspiration, as well as the volume (V) of inspired and expired air . The expiratory phases (P-Ext) are positive, with an overpressure compared to atmospheric pressure. The inspiratory phases (P-Int) are negative, with depression relative to atmospheric pressure. The alternation of variations makes it possible to characterize the respiratory rate. The surface of the variations makes it possible to characterize a relation to the volume (V) of inspired and restored air.

The graphs in Figures 7 to 10 show another example of pressure data recording, with a textile mask.

In FIG. 7, the graph shows the raw pressure data measured by the device (10), with the expiratory and inspiratory phases. The period T1 corresponds to a walk in the street, the period T2 corresponds to the ascent of one floor, the period T3 corresponds to the descent of two floors, the period T4 corresponds to the return to the street, the event T5 corresponds to a fit of coughing, and the T6 event corresponding to an apnea.

In figure 8, the graph shows a zoom of the pressures sampled between 17:03:30 and 17:04:30, with the expiratory and inspiratory phases.

In FIG. 9, the graph shows the raw data measured by the device (10), with the expiratory and inspiratory phases, but also the variations in atmospheric pressure (Patm) due to the change in altitude of the mask wearer.

In FIG. 10, the graph shows a first processing of the signal corresponding to the measured data. In order to limit the impact of atmospheric pressure variations, the atmospheric pressure level at each instant of the measurement is subtracted from the absolute value sampled.

In figure 11, the graph shows a second processing allowing to highlight the local minimums and maximums of pressure, in order to recover the data of frequencies, amplitudes, and thus easily highlight apnea, coughing, snoring, speech, etc. ..

The device (10) allows the implementation of a large number of applications:

- Covid assessment.

- Evaluation of sleep apnea.

- Evaluation of snoring.

- Monitoring of COPD (obstructive bronchopneumopathy, asthma, etc.).

- Follow-up of fragile patients during pollution peaks. - Follow-up of the elderly.

- Protection of workers.

- Evaluation of the quantity of air exchanged in a polluted environment.

If the long-term analysis has become common at the cardiac level, currently this type of analysis does not exist at the respiratory level for lack of suitable equipment (cost, comfort, acceptance...).

At the level of cardiac diagnosis, a (r)evolution has been brought about by the use of continuous ECG in the life of the patient. The portable ECG machine is called a “holter”. This name has come into common use to characterize continuous measurements in the lives of patients. This function does not yet exist at the respiratory level, using simple means compatible with the requirements defined above.

With very simple acquisition and recording means, the device (10) can be a valid candidate for “holter” type respiratory exploration:

- Data acquisition at mask level (1).

- Transmission of data to a smart phone ("smartphone" in English) - Transmission of data from the phone to the online cloud ("cloud" in English) for synthesis and provision of results to clinicians and patients.

Furthermore, the mask (1) and the device (10) can be shaped differently from FIGS. 1 to 5 without departing from the scope of the invention, which is defined by the claims. Furthermore, the technical characteristics of the different embodiments and variants mentioned above can be, in whole or for some of them, combined with each other. Thus, the mask (1) and the device (10) can be adapted in terms of cost, functionalities and performance.

Claims

1. Device (10) designed to equip a respiratory mask (1) and collect the respiratory data of a wearer (2), the device (10) comprising: an acquisition system (20) comprising a pressure sensor (21 ); a data transmission system (30); and a power source (40); characterized in that the device (10) constitutes a one-piece module.

2. Device (10) according to claim 1, characterized in that the module has a thickness less than or equal to 10 mm, a width less than or equal to 30 mm, and a length less than or equal to 30 mm.

3. Device (10) according to any one of the preceding claims, characterized in that the device (10) comprises an electronic card (50) on which are mounted the pressure sensor (21), the transmission system (30) and the power source (40).

4. Device (10) according to any one of the preceding claims, characterized in that the acquisition system (20) comprises a temperature sensor (22) provided for measuring the temperature of the air inside the mask (1).

5. Device (10) according to any one of the preceding claims, characterized in that the acquisition system (20) comprises an accelerometer (23) provided to record the movements of the device (10).

6. Device (10) according to any one of claims 1 to 5, characterized in that it comprises temporary fixing means in the mask (1).

7. Device (10) according to any one of claims 1 to 5, characterized in that it comprises permanent fixing means in the mask (1).

8. Mask (1) instrumented, comprising: an envelope (3) intended to be positioned on the face of the wearer (2); and a system (4) for attaching the envelope (3) to the wearer's head (2); characterized in that the mask (1) comprises a device (10) according to any one of the preceding claims.

9. Mask (1) instrumented according to claim 8, characterized in that the envelope (3) is made of textile material.

10. Method for collecting respiratory data, comprising the following steps: integrating a device (10) according to one of claims 1 to 7 in an instrumented mask (1); connecting the device (10) to an analysis apparatus; processing the data transmitted by the device (10).