WO2011026952A2

WO2011026952A2 - Nasal dilator

Info

Publication number: WO2011026952A2
Application number: PCT/EP2010/062986
Authority: WO
Inventors: Georges Magnin; Jacques Magnin
Original assignee: Oscimed Sa
Priority date: 2009-09-04
Filing date: 2010-09-03
Publication date: 2011-03-10
Also published as: WO2011026952A3; CH703013A2

Abstract

The present invention relates to an internal nasal dilator (1) made of a unitary piece of a porous material, capable of absorbing active liquid materials, wherein at least one area of said piece is impregnated with an active material capable of evaporating by the flow of air breathed into the nose. The invention also relates to kits for marketing such a nasal dilator. The invention further relates to a nasal dilator comprising: a first attachment portion (8), a first end (8a) of which is adjacent to a base (6) and a second end (8b) of which is near a reference plane XY, and resiliently connected to the base (6) such that the second end (8b) is tangential to the reference plane XY; and a second portion (10) forming a flange (10a) resiliently connected to the first portion so as to exert pressure toward the outside.

Description

Nasal dilator

Technical area

The present invention relates to the field of drugstore and pharmacy. It relates to a nasal dilator, in particular intended to allow the diffusion of an active substance.

State of the art

For the man, breathing through the nose allows in particular to regulate the temperature of the inspired air and moisten it before it reaches the lungs. An obstructed or clogged nose reduces or prevents this important dual function.

It has been noticed that in his sleep, mouth breathing is often the symptom of a person with nasal respiratory failure. When associated with snoring, this deficiency becomes a breathing difficulty of concern. Improving nasal breathing helps to reduce snoring. In the state of the art, various solutions are known for achieving this goal. In particular, nasal dilators, which may be external or internal, are known.

In the first case, using an adhesive tape device glued to the nose, outside the nostrils. However, it only slightly increases the respiratory rate, which does not significantly reduce snoring. Moreover, its use is difficult because this device does not stick on oily or wet skin.

In the second case, is inserted into the nostrils a dilator more vigorously spreading the nostrils. Some of the internal dilators also provide air filtration during inspiration to eliminate various dusts and pollen.

An example of such a dilator is described in patent application US2006266360A. This is a device inserted into the nose with a "V" -shaped structure whose branches carry at the ends a ring intended to exert a lateral pressure on the inner face of each nostril so that the nasal breathing flow is increased. However, such a device does not offer satisfactory performance. The inner face of each nostril being cone-shaped, it exerts pressure on the device tending to expel nostrils. In addition, the device is dimensioned so that the rings are inserted substantially halfway up the nostril. Now, the internal valves are situated beyond, precisely below the summit of the cones formed by the nostrils. The clearance is not complete and completely effective at the internal valves. In order to keep it in position, the device comprises at its base a local pinching intended to exert a relatively large point pressure on the septum, the nasal wall separating the two nostrils. This point pressure can be a source of irritations of the intra nasal skin making the use of this device uncomfortable. The user can then remove it unconsciously during sleep.

The present invention is intended to provide a nasal dilator free from these problems.

To improve the clearance of the airways, or to apply a therapeutic treatment, some devices have provided systems for distributing various products, drugs or essential oils. However, although interesting, existing devices have many disadvantages. For external devices, the efficiency first is relatively low. In addition, since the device must combine both a good adhesion to the skin and a sufficient diffusion capacity, the structure must necessarily be composite and induces a complex and expensive device. For internal devices, it has been proposed to insert buffers on the dilator, capable of diffusing products. Other devices combine a filter and a nozzle loaded with a drug, as for example the document US Pat. No. 4,267,831. Again, the proposed devices are complex and expensive.

The present invention also aims to provide a nasal dilator capable of diffusing various products, free from these drawbacks. Disclosure of the invention

More specifically, the invention relates to an internal nasal dilator characterized in that it is made in a one-piece piece of a porous material, having the ability to absorb active products in liquid form, and in that it is impregnated with an active product that can evaporate under the effect of the passage of inspired air in the nose.

[001 1] The invention also relates to kits for the implementation of this dilator.

The invention also relates to a nasal dilator having two branches arranged symmetrically with respect to a first reference plane XY, the two branches being joined by a base and extending in a second plane YZ perpendicular to the XY reference plane. each branch being intended to be inserted into a nostril and comprising:

a first fastening portion, a first end of which adjoins the base and whose other end approaches the reference plane XY, elastically connected to the base so that the second end is brought tangentially to the reference plane XY,

- A second part forming a wing connected elastically to the first part so as to exert pressure to the outside.

The first part and the second part are dimensioned so that the wing engages in the cone of the nose and bypasses the internal valve of the nose, the second ends of the first parts of the two branches being supported on the septum to maintain the dilator. Brief description of the drawings

Other details of the invention will appear more clearly on reading the description which follows, with reference to the accompanying drawing showing an example of possible embodiment.

Mode (s) of realization of the invention

The description below is given with reference to a particular example given by way of non-limiting illustration of the invention. Figure 1 shows a nasal dilator 1 having two branches 2 and 4 arranged symmetrically with respect to a first reference plane XY, the two branches 2 and 4 being joined by a base 6 and extending in a second plane YZ perpendicular to the reference plane XY. Each branch 2 and 4 is intended to be inserted into a nostril and comprises:

a first fastening portion 8, a first end 8a of which adjoins the base 6 and whose other end 8b approaches the reference plane XY; the first part 8 is elastically connected to the base 6 so that the second end 8b is brought tangentially to the reference plane XY,

- A second portion 10 forming a wing 10a elastically connected to the first part so as to exert pressure to the outside.

The first portion 8 and the second portion 10 are dimensioned so that the wing 10a engages in the cone of the nose so that it bypasses the internal valve of the nose. The internal valve being below the top of the cone, the wing 10a bypasses the top of the cone and exerts pressure on the cone so that the breathing duct is expanded. The second ends 8b of the first parts 8 of the two branches 2 and 4 rest on the septum to maintain the dilator.

For the establishment of the dilator, a user grasps the base 6 between the thumb and forefinger to position the branches 2 and 4 at the entrance of each nostril. Then, a support on the base 6 by the thumb or forefinger makes it possible to introduce the nasal dilator 1 into the nose until the base 6 comes into contact with the septum at the entrance of the nose. The device is then in place. Each wing 10a is engaged in the cone of each nostril which, by reaction, exerts a pressure on the wing 10a transmitted to the end 8b of the first portion 8. Therefore, the end 8b is pressed on the intranasal wall of the septum and ensures the maintenance in the nose of the device.

The invention provides, in addition, a maintenance of the increased device with the wings 10a. In particular, the end of each wing 10a, parallel to the reference plane XY and perpendicular to the second plane YZ, comprises a bevel. Thus, after the installation of the device, the wing 10a has a better anchorage to the wall of the nose and tends to slightly oppose its extraction. It is important to note, however, that the flexibility and elasticity of the device ensures a light anchorage, never inconvenient for the user. In particular, it is not a point pinch as in the state of the art, but a support surface with a bevel to reduce pressure and increase comfort of use.

The device of the invention may also have, on its surface, streaks or relief structures providing additional support of the dilator. More specifically, each end 8b facing the reference plane XY may comprise at least one anti-slip grooves oriented parallel to said reference plane XY and perpendicular to the second plane YZ so as to provide additional support bearing on the inner wall of the septum .

The base 6 is the only part of the dilator which, after insertion, remains extranasal, allowing the user to grasp it to extract the dilator 1 after use.

When set up, the dilator 1 significantly increases the intranasal section while the internal valves are also well cleared. This has the effect of reducing the pressure and velocity of the air in the nasal duct, thus minimizing turbulent flow and snoring.

The total length of the device is between 20mm and 30mm, more particularly between 22mm and 26mm. Models of different lengths are advantageously proposed in order to best adapt to the morphology of each user.

Each branch 2 and 4 is, moreover, advantageously arranged to present a narrowing 12. Precisely, the projection of each branch on the reference plane XY has a narrowing 12 at the junction between the first portion 8 and the second part 10. This has the effect of promoting the flow of mucus through the nose and allow the passage of air. Thus, the projection of each branch 2 and 4 on the reference plane XY has a width ranging from 3mm for the shrinkage 12, up to 12mm for the first part 8 of fixing or the wing 10a.

In addition, the advantageous embodiment of the two branches 2 and 4 and the base

6 in one piece, in the same strip of continuous surface material, facilitates its industrial manufacture.

It is important to note also that the lack of rigid reinforcement makes the dilator particularly pleasant to wear.

[0028] The comfort is increased by the use of soft and soft materials. In particular, the nasal dilator 1 is made of a hypoallergenic material and conforms to medical standards, such as caviton,

TPE / pebax ®.

Advantageously, the dilator is made in one piece. In other words, the two branches 2 and 4 and the base 6 are made of the same strip of continuous surface material. Such a dilator is made by molding or injection, which is particularly interesting at the industrial level.

The appropriate materials must not only have interesting properties both in terms of the elasticity imparted to the branches and wings of the dilator, as the level of ease of implementation at the industrial level (molding, demoulding. ..). Of course, the proper materials must also allow comfortable use while meeting medical standards.

Surprisingly, it has been noticed that certain porous materials have, in addition, the ability to absorb active products in liquid form (the liquid form includes, in addition to a pure body or a mixture of pure liquids, solutions, oils, suspensions, or gels ...). Particularly interestingly, it has been noticed that these liquids can be absorbed directly by the material of the dilator, this product can then be micro-diffused into the blood of the user by evaporation, the latter being accentuated by the flow of air provoked with each inspiration. Thus, according to another aspect of the invention, the portions intended to spread the nostrils are impregnated with active product. It goes without saying that an active product may comprise one or more aromatic molecules, each having different specific properties.

The dilator mentioned above is very well suited for product diffusion, the outer faces of the parts 8, preferably, are impregnated to limit direct contact between the active product and the intranasal mucosa. The inner faces of the wings 10 could also be used. In other words, the functions of dilation of the nostrils and diffusion of a product are performed by the same elements of the dilator, unlike the devices of the state of the art.

[0034] Contrary to what was expected, the product remains absorbed in the material and does not spread inside the nose. In addition, despite a very close contact, or even direct, between the active products and the nasal mucosa, there is no disadvantage from this contact (irritation, burns ...). It is even probable that, in addition to diffusion through the airways and lungs, the active products also pass directly into the blood of the user via the capillaries of the nose, resulting in increased efficiency.

Among the materials combining all its qualities, we will remember the Caviton, Mediprene®, TPE / pebax ® or evatane, which has remarkable absorption capacity. Especially, the EVA 28-05 (with 27 to 29% vinyl acetate, according to a FTIR measurement method) combines all the qualities required, both in terms of mechanical qualities, wearing comfort and ease of use. implemented, only at the level of its absorption capacity.

It will also be noted that, in the case of a dilator according to the example above, the wings, thanks to their shape and their positioning with reference to the valves of the nose, serve as a deflector and guide the vapors of matter active in the respiratory ducts or internal valves.

In order to improve the diffusion and retention of the product, the dilator may comprise, particularly in the areas intended to be impregnated, structures, streaks or cells (not shown in the drawing). These structures make it possible to increase the active product absorption surface and the exchange surface between the dilator and the air, to improve the diffusion. In the case of a dilator as described above, these structures can therefore be arranged on the outer faces of the parts 8.

The dilator according to the invention may be marketed pre-impregnated with a predefined active ingredient. Advantageously, the dilator can be marketed in the form of a kit comprising several dilators of different sizes, allowing a user to choose an optimum size dilator. In order to avoid the evaporation of the product before its use, the kit provides a packaging in which each dilator is encapsulated under vacuum, preferably individually. This encapsulation can be done directly with the blister or by means of an intermediate box, itself housed in the blister.

One can also consider a marketing in the form of a kit, including:

a dilator as proposed above, capable of absorbing an active substance,

one or more bottles containing products, and

- An application device, to apply, optionally, one of the products on the dilator.

When the kit comprises several flasks, they may advantageously comprise different active products (each active product comprising a single type of aromatic molecule, a single essential oil or a mixture), for example for different indications (the one relaxing and another decongestant respiratory tract).

The application device can be very simple, in the form of a stick of a brush, a micro-spray, a felt, a roll-on (ball system), or a small spatula depending on the viscosity of the product to be applied. We will also include in the concept of application device, a drip system to directly apply the product. When the product has been fully absorbed and the dilator surface is dry, introduce it into the nose. When all the product has been released, it can be recharged with the same or with another product. A user manual may also be proposed with the kit.

The present description has been given by way of non-limiting illustration of the invention and the skilled person can still provide various alternatives directly from the description given above, without departing from the defined scope. by the claims. In particular, the dimensions given above are only examples that can be modified. It will be noted that the dilator according to the invention, made in a single piece of a porous material, having the ability to absorb active products in liquid form, can take a form that is not limited to the particular form described, even if it finds there a particularly advantageous application.

Thus is proposed a particularly simple and effective nasal dilator. It can allow the user to easily distribute a therapeutic product while offering him the opportunity to change the product he wants to inspire. In addition, the questioning of the solutions adopted in the state of the art and the selection of particularly suitable materials greatly improves the industrialization and the cost price of these devices.

Claims

claims

Internal nasal dilator, characterized in that it is made in a single-piece piece made of a porous material, having the ability to absorb active products in liquid form, and in that at least one zone of said part is impregnated with an active product likely to evaporate under the effect of the passage of inspired air in the nose.

Nasal dilator (1) according to claim 1, characterized in that the dilator comprises portions intended to spread the nostrils and in that the faces of said portions intended not to come into contact with the nasal mucous membranes are impregnated with active product.

Nasal dilator (1) according to one of claims 1 and 2, characterized in that it is made of a material selected from caviton, TPE / pebax®, Medprene® and evatane.

Nasal dilator (1) according to claim 3, characterized in that the evatane is Eva 28-05.

Nasal dilator (1) according to one of the preceding claims, characterized in that it comprises wings (10) acting as a deflector for channeling the vapors of active product in the airways.

Kit, comprising a plurality of dilators according to one of the preceding claims impregnated with an active product, said dilators being of different sizes, each dilator being encapsulated under vacuum, preferably individually. 7. Kit including at least one nasal dilator (1) made in a single piece made of a porous material, having the ability to absorb active products in liquid form,

at least one bottle comprising an active product that can be absorbed by the dilator and to evaporate under the effect of the passage of the inspired air into the nose when the dilator is inserted into the nose of a user, and

8. Kit according to claim 7, characterized in that it comprises a plurality of bottles each comprising different active products.

9. Kit according to one of claims 7 and 8, characterized in that it comprises a plurality of dilators of different sizes.

10. Kit according to one of claims 6 to 9, characterized in that it further comprises a user manual. A method of using a kit according to one of claims 7 to 10, comprising the steps of:

- apply one of the products of the kit on the dilator,

- wait until the dilator has absorbed the product,

- insert the dilator in the nose.

12. The method of claim 1 1, characterized in that the steps can be repeated after diffusion of the previously absorbed product.

13. Nasal dilator (1) having two branches (2 and 4) arranged symmetrically with respect to a first reference plane XY, the two branches (2 and 4) being joined by a base (6) and extending in a second YZ plane, perpendicular to the XY reference plane, each branch (2 and 4) being intended to be inserted into a nostril and comprising

a first fastening part (8) having a first end (8a) adjacent to the base (6) and the other end (8b) of which is close to the reference plane XY, elastically connected to the base (6) so as to the second end (8b) is brought tangentially to the XY reference plane,

a second wing-forming portion (10a) resiliently connected to the first portion to exert an outward pressure, the first portion (8) and the second portion (10) being dimensioned such that the wing (10a) engages in the cone of the nose and bypasses the internal valve of the nose, the second ends (8b) of the first parts (8) of the two branches (2 and 4) resting on the septum to ensure maintaining the dilator.

14. Nasal dilator (1) according to claim 13, characterized in that the total length of the device is between 20 and 30mm.

15. Nasal dilator (1) according to any one of claims 13 to 14, characterized in that the projection of each branch (2 and 4) on the XY reference plane has a width of between 3mm and 12mm.

16. Nasal dilator (1) according to any one of claims 13 to 15, characterized in that the end of each wing (10a) is parallel to the reference plane XY and perpendicular to the second plane YZ and in that it has a bevel to maintain the dilator.

17. Nasal dilator (1) according to any one of claims 13 to 16, characterized in that the projection of each branch on the reference plane XY has a narrowing (12) at the junction between the first part (8). ) and the second part (10).

18. Nasal dilator (1) according to any one of claims 13 to 17, characterized in that the two branches (2 and 4) and the base (6) are made in one piece in the same strip of surface material keep on going.

19. Nasal dilator (1) according to any one of claims 13 to 18, characterized in that the nasal dilator (1) is made of a hypoallergenic material and in accordance with medical standards including caviton, TPE / pebax®, Mediprene® and evatane.

20. Nasal dilator (1) according to any one of claims 13 to 19, characterized in that the nasal dilator (1) has a raised structure each second end (8b) opposite the XY reference plane to ensure the maintenance dilator.

21. Nasal dilator (1) according to claim 20, characterized in that said relief structure is formed by at least one stripe oriented parallel to said reference plane XY and perpendicular to the second plane YZ. 22. Nasal dilator (1) according to one of claims 13 to 21, characterized in that it is made in one piece piece of a porous material, having the ability to absorb active products in liquid form, and in that at least one zone of said part is impregnated with an active product that can evaporate under the effect of the passage of the inspired air in the nose.

23. Nasal dilator (1) according to claim 22, characterized in that the outer faces of the parts (8) or the inner faces of the wings (10) are impregnated with active product.