Device for modifying nasal breathing

Abstract

The invention relates to a device for modifying nasal breathing, comprising two nasal inserts (1a, 1b), each provided with an air circulation channel (13a, 13b) opening at a lower end (9a, 9b) and an upper end (11a, 11b) of the corresponding insert, and means (3a, 3b) for connecting the inserts (1a, 1b) to one another.

Description

DESCRIPTION TITLE: Nasal Breathing Modification Device

[0001] The present invention relates to the field of medical devices.

[0002] The diaphragm is the main muscle of ventilation and a major stabilizer of the trunk (llidi and Romer 2022).

[0003] Its complete activation results in abdominal breathing, ideal for optimizing ventilation and respiratory kinetics.

[0004] Dysfunctional ventilation, on the contrary, promotes excessive activation of the thoracic and clavicular muscles, accessory inspiratory muscles, while the diaphragm is only partially used, or not at all (Janssens, Brumagne et al. 2010); (Pilarski, Leiter et al.).

[0005] This situation leads to a high respiratory rate, a source of stress due to imbalance of the autonomic nervous system (Baekey, Molkov et al. 2010), but also trunk instability.

[0006] These two elements are aggravating factors for disorders such as chronic lower back pain, a health scourge with significant economic repercussions (11.5 million workdays lost per year, source INRS).

[0007] Reactivating the diaphragm is a simple and effective solution to restore functional breathing, essential for preventing and improving problems related to trunk instability and stress.

[0008] However, classic voluntary activation of the diaphragm often remains incomplete: it generally only mobilizes the anterior pillars.

[0009] However, the posterior pillars play a crucial role in trunk stabilization and complete respiratory movement.

[0010] The present invention aims in particular to provide a device of simple design, easy to implement and inexpensive to mobilize in particular the posterior pillars of the diaphragm.

[0011] This goal of the invention is achieved with a nasal breathing modification device, comprising two nasal inserts each provided with an air circulation channel opening at a lower end and an upper end of the respective insert, and means for connecting the inserts together, in which each channel forms an angle with respect to the axis of the respective insert, being inclined towards the anterior face of this insert.

[0012] Thanks to these characteristics, the device according to the invention allows, when the person wearing it inhales, the flow of inhaled air towards the upper part of the nasal cavity, which is rich in nerve endings whose stimulation promotes slow and deep breathing, allowing the posterior pillars of the diaphragm to be activated.

[0013] The angle formed by each channel relative to the axis of the respective insert allows the airflow to be directed towards the anterior wall of the nose, and subsequently towards the upper part of the nasal cavity.

[0014] In addition, restricting the flow of inhaled air forces the inhaling person to contract the posterior part of the diaphragm, which also contributes to the stimulation of the posterior pillars.

[0015] These two actions working together make it possible to correct dysfunctional breathing and to restore functional and stable ventilation.

[0016] In this way, we can correct disorders related to stress and trunk instability, such as lower back pain.

[0017] Unlike prior art devices which focus solely on restricting nasal airflow for muscle strengthening purposes, the device according to the invention allows for acting on the orientation of nasal airflow for postural correction purposes.

[0018] The particular orientation of this flow shifts the load onto the posterior pillars, leading to trunk stabilization, in order to reduce stress and posture-related disorders.

[0019] Depending on other optional features of the present invention, taken alone or in combination:

[0020] - the channels are free of obstruction to air circulation: the absence of such obstructions allows for the generation of a laminar airflow, free of turbulence, in the nasal cavity;

[0021] - the ratio between the internal diameter of these channels and the average diameter of the inserts is between 1 / 10 and 1 / 3, and preferably between 1 / 5 and 1 / 3: these dimensions allow a resistance to air circulation which is optimal for making the posterior pillars of the diaphragm work;

[0022] - each channel has a cross-section that is essentially constant over its entire length: such a constant cross-section is simple to achieve, and allows for a coherent and targeted airflow;

[0023] - said angle is between 5° and 25°, and is preferably equal to 20°: such an orientation allows the airflow to be directed optimally towards the upper part of the nasal cavity;

[0024] - each insert has a bevel extending between its anterior part and its upper end, so that the respective channel opens onto a substantially flat part of the upper part of the respective insert: such a bevel allows the airflow to be directed towards the lower part of the sinuses;

[0025] - the channel of each insert opens flush with the lower and upper parts of that insert: this feature allows for a more targeted jet of air;

[0026] - said inserts are made of flexible plastic or silicone: this material offers the desired ergonomics and dimensional adaptability;

[0027] - said means of connection include at least one, and preferably two arches connecting the inserts together: these loads allow the whole to have its structural strength;

[0028] - said arches are made of plastic material such as PVC: such a material has the desired rigidity, while offering elasticity to adapt to different nostril shapes.

[0029] Other features and advantages of the invention will become apparent from the following description, with reference to the attached figures, which illustrate: [Fig. 1]: A perspective view of the nasal breathing modification device according to the invention, [Fig. 2]: a side view of this device, with one of its channels represented by a dotted line, [Fig. 3]: a cross-sectional view of this device, along plane lll-lll of figure 2, [Fig. 4]: a view from below of this device, [Fig. 5]: a top view of this device, [Fig. 6]: Cross-sectional views of the nasal cavity of a person with (figure 5a) and without (figure 5b) the device according to the invention, with arrows representing the circulation of inspired air inside the nasal cavity, [Fig. 7]: views of an alternative embodiment of the device according to the invention comprising a removable support, where Figure 7a is a perspective view showing this support intended to receive the nasal inserts, Figure 7b is a top view of this support, and Figure 7c is a bottom view of this support, [Fig. 8]: a comparative graph illustrating the effect of airflow orientation on the stabilometric surface, and [Fig. 9]: a graph illustrating the evolution of lumbar discomfort in users of the device.

[0030] For clarity, identical or similar elements are identified by identical or similar reference symbols across all figures.

[0031] Furthermore, to facilitate understanding of the correspondence between the different figures, we have placed on each of them an XYZ coordinate system forming a direct orthogonal trihedron.

[0032] Referring in particular to figures 1 and 3, it can be seen that the nasal breathing modification device according to the invention comprises two inserts la, lb connected to each other by at least one, and preferably two arches 3a, 3b (see figures 4 and 5).

[0033] As shown in particular in Figure 2, each insert la, lb has an anterior part 5 intended to be positioned against the anterior wall of a person's nose, a posterior part 7 intended to be positioned against the posterior wall of this nose, a lower end 9a, 9b intended to be positioned outside the nostrils of this person, and an upper end lia, 11b intended to be positioned inside the nostrils of this person.

[0034] As can be seen in particular in figures 2 and 3, each insert la, lb has a general frustoconical shape - alternatively, this shape can be substantially cylindrical.

[0035] Each insert la, lb is traversed from its lower end 9 to its upper end lia, 11b by an air circulation channel 13a, 13b.

[0036] This channel 13a, 13b can be central and parallel to the axis of revolution A of the insert, or form with it an angle Œ between 5° and 25°, and preferably of the order of 20°, as can be seen in figure 2: in the latter case, this channel 13a, 13b starts substantially from the center of the lower end 9a, 9b of the insert, and opens into the upper end 11a, 11b of the insert closer to the anterior part 5 of the insert than to the posterior part 7 of it, as can be seen in figure 2.

[0037] As can also be seen in this figure, channel 13, 13b opens flush with the lower ends 9a, 9b and upper ends 1a, 11b of the insert.

[0038] Preferably, as can be seen in figures 1 to 3, each insert la, lb has a bevel 15a, 15b extending between its front part 5 and its upper end lia, 11b, so that the channel 13a, 13b opens onto a substantially flat part of the upper part lia, 11b of the insert.

[0039] As can be seen in particular in figures 2 and 3, the channel 13a, 13b of each insert la, lb is free of obstruction, and its section is preferably constant over its entire length.

[0040] The ratio between the diameter d of this channel 13a, 13b and the average diameter Dm of the insert la, lb is between 1 / 10 and 1 / 3, and preferably between 1 / 5 and 1 / 3.

[0041] By "average diameter", we mean the diameter of the insert la, lb taken at its mid-height.

[0042] Inserts Ia, Lb can be made of soft plastic or, preferably, medical grade silicone, known for its hypoallergenic properties, biocompatibility, resistance to deformation and ease of maintenance.

[0043] Several sizes of inserts can be considered, so that they can fit inside a person's nostrils, completely blocking them, and are oriented approximately 45° from the vertical, as can be seen in Figure 5b.

[0044] The arches 3a, 3b connecting between the inserts la, b can be made of flexible and resistant plastic material such as PVC, offering sufficient elasticity to adapt to different nostril shapes.

[0045] In the alternative embodiment shown in Figure 7, the device according to the invention comprises a support for example made of plastic comprising two bases 27a, 27b connected to each other by a bridge 29, each traversed by a respective tube 31a, 31b inclined according to said desired angle Πwith respect to the axes of the bases.

[0046] On each of the tubes 31a, 31b, the respective inserts la, lb are inserted.

[0047] This alternative embodiment with removable inserts allows for easy cleaning of these inserts, as well as the use of different sized inserts for both nostrils, for example for people who have undergone a displacement of the nasal septum.

[0048] The method of use and advantages of the nasal breathing modification device according to the invention result directly from the preceding description.

[0049] The person wishing to restore functional breathing, to prevent and improve problems related to trunk instability and stress, places the device according to the invention as can be seen in figure 5b, that is to say with the upper ends lia, 11b of the inserts la, lb positioned inside the nostrils, and with the flat parts formed by the bevels 15a, 15b oriented towards the side of the anterior wall 19 of the nose.

[0050] In this position, the axes A of the inserts la, lb are substantially inclined at 45° with respect to the vertical, this vertical being represented by the direction of the spine 21 of the person in figure 5b.

[0051] Once the insert is positioned in this way, the person can breathe in slowly and deeply.

[0052] This inspiration has the effect of forcing the circulation of air inside the channels 13a, 13b of the inserts, with a reduced flow rate compared to an air circulation without insert (figure 5a).

[0053] This reduction in flow rate forces the person to exert additional effort, which mechanically engages the posterior pillars of the diaphragm, thus strengthening trunk stability and facilitating deep abdominal breathing: the device according to the invention thus makes it possible to stimulate the main respiratory muscles in a targeted manner.

[0054] Furthermore, the airflow within each channel generates, at the outlet of the channel, therefore on the flat part of the beveled upper end of the insert, a fine, coherent jet directed towards the anterior wall of the person's nose.

[0055] As indicated by the arrows in Figure 5b, this jet is then directed towards the upper part 23 of the person's nasal cavity, unlike a breathing situation without the device according to the invention shown in Figure 5a, where the airflow is directed more naturally towards the bottom 25, i.e. towards the posterior part of the nasal cavity before reaching the larynx.

[0056] As it circulates in the upper part of the person's nasal cavity, the airflow stimulates the abundant nerve endings in this region, particularly the trigeminal fibers; this stimulation also contributes to the activation of the posterior pillars of the diaphragm, and to slow, deep, and coordinated breathing.

[0057] Unlike dysfunctional breathing, characterized by overuse of accessory inspiratory muscles (thoracic and clavicular) and partial or no use of the diaphragm, the device according to intention promotes natural and optimal respiratory mechanics.

[0058] Dysfunctional breathing often leads to a high respiratory rate, trunk instability, and an imbalance of the autonomic nervous system, exacerbating stress and postural disorders.

[0059] The device according to the invention corrects these imbalances by restoring a complete and functional activation of the diaphragm (Zhai, Zhang et al. 2024).

[0060] Furthermore, the device according to the invention avoids the imbalance of ventral breathing, promoting complete abdominal breathing.

[0061] Finally, the device according to the invention amplifies sensory feedback through the specific redirection of the airflow, allowing the user to perceive the activation of the diaphragm in the dorsal region.

[0062] This heightened perception improves body awareness and helps correct faulty breathing mechanisms.

[0063] The originality of the invention lies particularly in its objective of specifically directing the airflow, which conventional nasal dilators or muscle strengthening devices do not do.

[0064] Reinforcement devices focus on restricting airflow rather than directing it, while dilators simply separate the nasal walls.

[0065] As comparative studies demonstrate, the effects on posture differ considerably between a simple restriction and a restriction combined with a specific orientation.

[0066] Figure 8 illustrates the effect of airflow orientation on the stabilometric surface, measured with a stabilometry platform.

[0067] In this comparative study, three conditions were tested: a condition without a device (reference), a condition with a straight but narrowed channel device (representing a simple flow restriction), and a condition with the device according to the invention, whose channel is oriented towards the upper area of ​​the nasal cavities (representing a restriction and a flow orientation).

[0068] The results, normalized to the condition without the device, show that a device with a simple straight channel increases the stabilometric surface, which means a loss of balance.

[0069] Conversely, the device according to the invention, with its oriented channel, causes a decrease in the stabilometric surface.

[0070] This demonstrates an improvement in stability, confirming that the specific orientation of the airflow is an essential characteristic to achieve the desired technical effect, namely the activation of the posterior pillars of the diaphragm and consequently, the improvement of trunk stability.

[0071] Figure 9 illustrates the functional effect of the device according to the invention on lumbar comfort.

[0072] A follow-up by self-assessment was carried out to evaluate the lumbar comfort provided by the device.

[0073] The values ​​presented correspond to the average of the self-assessed daily lumbar discomfort scores on a scale of 0 to 10.

[0074] The subjects included (n=7) were all under medical care in physiotherapy for chronic lower back pain without improvement for at least three months.

[0075] They wore the device for at least ten minutes a day.

[0076] A matched intra-subject analysis between the beginning and end of the usage period, performed using a non-parametric Wilcoxon test, revealed a statistically significant decrease in lumbar discomfort during the time of use of the device (p < 0.01), suggesting a functional effect associated with its use.

[0077] Activating the posterior pillars of the diaphragm thus appears to have a positive effect on lumbar comfort.

[0078] Naturally, the invention described above is by way of example. It is understood that a person skilled in the art is capable of carrying out different embodiments of the invention without departing from its scope. References Baekey, DM, YI Molkov, JF Paton, IA Rybak and TE Dick (2010). "Effect of baroreceptor stimulation on the respiratory pattern: insights into respiratory-sympathetic interactions." Respir Physiol Neurobiol 174(1-2): 135-145. Birdee, G., K. Nelson, K. Wallston, H. Nian, A. Diedrich, S. Paranjape, R. Abraham and A. Gamboa (2023). “Slow breathing for reducing stress: The effect of extending exhale.” Complementary Therapies in Medicine 73: 102937. Illidi, CR and LM Romer (2022). "Stabilizing function of the human diaphragm in response to involuntary augmented breaths induced with or without lower-limb movements." Exp Physiol 107(12): 1477-1492. Janssens, L, S. Brumagne, K. Polspoel, T. Troosters and A. McConnell (2010). "The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain." Spine (Phila Pa 1976) 35(10): 1088-1094. Pilarski, J. Q„ J. C. Leiter and R. F. Fregosi Muscles of Breathing: Development, Function, and Patterns of Activation. Comprehensive Physiology: 1025-1080. Zhai, H., L. Zhang, J. Xia and C. Li (2024). "The Efficiency of Respiratory Exercises in Rehabilitation of Low Back Pain: A Systematic Review and Meta-Analysis." Journal of Sport Rehabilitation 33(3): 189-200.

Claims

DEMANDS 1. Nasal breathing modification device, comprising two nasal inserts (la, lb) each provided with an air circulation channel (13a, 13b) opening at a lower end (9) and at an upper end (lia, 11b) of the respective insert, and means for connecting the inserts (la, lb) to each other, wherein each channel (13a, 13b) forms an angle (a) with respect to the axis (A) of the respective insert, being inclined towards the anterior face (5) of this insert.

2. Device according to claim 1, in which the channels (13a, 13b) are free from obstruction to air circulation.

3. Device according to any one of claims 1 or 2, wherein the ratio between the internal diameter of these channels (13a, 13b) and the average diameter of the inserts (la, lb) is between 1 / 10 and 1 / 3, and preferably between 1 / 5 and 1 / 3.

4. Device according to any one of the preceding claims, wherein each channel (13a, 13b) has a substantially constant cross-section over its entire length.

5. Device according to any one of the preceding claims, wherein said angle (A) is between 5° and 25°, and is preferably equal to 20°.

6. Device according to any one of the preceding claims, wherein each insert (la, lb) has a bevel (15a, 15b) extending between its front part (5) and its upper end (lia, 11b), so that the respective channel (13a, 13b) opens onto a substantially flat part of the upper part (lia, 11b) of the respective insert.

7. Device according to any one of the preceding claims, wherein the channel (13a, 13b) of each insert (la, lb) opens flush with the lower (9a, 9b) and upper (lia, 11b) parts of that insert.

8. Device according to any one of the preceding claims, wherein said inserts (la, lb) are formed of flexible plastic or silicone.

9. Device according to any one of the preceding claims, wherein said connecting means comprise at least one, and preferably two arches (3a, 3b) connecting the inserts, formed of plastic such as PVC.

10. Device according to any one of the preceding claims, comprising a support (27a, 27b, 29, 31a, 31b) for receiving said inserts (la, lb), mounted in a removable manner on this support.

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