Nasal dilator

Abstract

The present invention is enclosed in otolaryngology, particularly in the area of devices for improving nasal air-flow. It is an object of the present invention a nasal dilator comprising two tubular elements connected to each other by means of a connection band, forming a single body structure, each one tubular element configured to be positioned inside a nostril of a human nose, comprising two openings and three sections, each section having a same longitudinal axis, wherein the second section is located between the first and the third section; characterized by the first opening being located in the first section and the second opening being located in the third section; the diameter of the first opening being larger than the diameter of the second opening; and by the thickness of the second section being larger than the thickness of the first and third sections. The nasal dilator is made of biocompatible thermoplastic silicone or silicone resins which are pliable and facilitate the application of the nasal dilator inside the nasal cavity. This solution prevents the collapsing of the nasal passages, increasing the air-flow, while being comfortable and secure.

Description

[0001] DESCRIPTION

[0002] NASAL DILATOR

[0003] FIELD OF THE INVENTION

[0004] The present invention is enclosed in otolaryngology, particularly in the area of devices for improving nasal air-flow.

[0005] PRIOR ART

[0006] Approximately 35% of people over the age of 40 suffer from daily or weekly snoring, often accompanied with Obstructive Sleep Apnea (OSA) caused by nasal obstruction and narrowing of the nasal passages. This condition often leads to mouth breathing, which destabilizes the upper airway and is linked to serious health conditions, such as low blood oxygen levels and high blood pressure, among other.

[0007] There are several commercial solutions designed to address nasal obstruction and improve nasal breathing, usually by widening the nostrils and nasal passages inside the nasal cavity. Devices such as nasal strips can widen the nostril to improve the air-flow to the nasal cavity, however the effects are mild and the strip adhesive can cause some discomfort over time, such as skin irritation and itching.

[0008] Alternatively, internal nasal dilators are small devices which are placed inside the nostrils into the nasal cavity and maintain the air-flow by preventing the collapse of the nostrils and nasal passages. Although nasal dilators lead to comparatively higher airflow and better sleep quality, the current nasal dilators that are commercially available still cause a slight discomfort.

[0009] There are several types of nasal dilators currently in the market. One type of nasal dilator is shaped to be positioned against the nasal septum, which becomes painful. There are also nasal dilators which are purposely oversized so to put continuous pressure inside the nasal cavity for the dilator to stay in place at all times, which also cause constant tension and irritation to the nasal epithelium. Other options consist in nasal dilators consisting in cones made from hard plastic of metal which are too rigid and uncomfortable for daily use.

[0010] Discomfort from nasal dilators in general is caused by the mismatch between the natural size and shape of the nostrils and nasal cavity with the size and shape of the nasal dilators, which is always a problem, as no nose or nostril is the same size. This discomfort often drives the user to inadvertently scratch the nose and, consequently, to displace the nasal dilator or even to lose the nasal dilator during the sleep cycle. The displacement or loss of the nasal dilator leads to nasal obstruction, mouth breathing and ultimately leads to obstructive sleep apnea.

[0011] The proposed invention innovatively provides a solution for such problem.

[0012] SUMMARY OF THE INVENTION

[0013] It is an object of the present invention a nasal dilator comprising two tubular elements connected to each other by means of a connection band, forming a single body structure, each one tubular element configured to be positioned inside a nostril of a human nose, comprising two openings and three sections, each section having a same longitudinal axis, wherein the second section is located between the first and the third section; said first section being a proximal section, said second section being an intermediate section and said third section being a distal section; characterized by the first opening being located in the first section and the second opening being located in the third section; the diameter of the first opening being larger than the diameter of the second opening; and by the thickness of the second section being larger than the thickness of the first and third sections. Each tubular element is positioned inside a human nostril, allowing an unobstructed air flow through both the first and second opening during the normal respiration cycle of inhalation and exhalation, thus preventing the onset of obstructive sleep apnea (OSA).

[0014] In an advantageous aspect of the present invention, the second section of each tubular element has an increased thickness compared to both the proximal first section and distal third section of the tubular element, wherein the increased thickness increases the resistance against the collapse of the tubular element walls, thus maintaining the air flow unobstructed for long periods of time.

[0015] In addition, the diameter of the first opening of the first section being larger than the diameter of the second opening of the third section allows the first opening to be fitted to the wider entrance of the nasal cavity and the second opening to be fitted to the narrower segment of the inner nasal cavity. Therefore, the nasal dilator is configured to be fitted comfortably inside a human nostril as its dimensions match the overall shape of the nasal cavity, wherein the nasal dilator does not exert excessive pressure to the nasal epithelium in narrower segments of the nasal cavity and also maintains its position in wider segments of said nasal cavity.

[0016] In a preferred aspect of the present invention, the ends of the connection band are attached to the first section of each tubular element so that said connection band is positioned perpendicularly to the longitudinal axis of each tubular element. This preferred configuration allows the connection band to be fitted across the nasal columella, between both nostrils, to prevent the tubular elements from being inserted too deep inside the nasal cavity, and also to facilitate the removal of the nasal dilator by pulling said connection band.

[0017] Moreover, each tubular element further comprises at least one protrusion that extend radially from the outer surface of the first section, so that said protrusion can be accommodated against the nasal cavity wall, thus preventing the tubular element to slide outwards from the nasal cavity. Preferably, the protrusion is positioned perpendicularly to the connection band so that said protrusion can be accommodated inside the nasal cavity, specifically in the spaces existing towards the tip of the nose and / or towards the base of the nose near the anterior nasal spine of maxilla. The nasal cavity at the tip of the nose has a depth of 1 - 6 mm in all humans, therefore it is an appropriate space for the protrusion to be accommodated in.

[0018] The protrusion comprises a pyramidal shape that declines towards the second section of each tubular element, following the natural shape of the nasal cavity walls, wherein the apex of the pyramidal shaped protrusion is round so that it does not harm the nasal epithelium.

[0019] In a preferred embodiment of the present invention, the nasal dilator comprises two diametrically opposed protrusions in each tubular element, so that one protrusion is fitted inside the nasal cavity towards the tip of the nose, and the other protrusion is accommodated inside the nasal cavity at the base of the nose near the anterior nasal spine of maxilla. This preferred configuration further prevents the tubular elements of sliding out from the nasal cavity by providing two blocking sites, one at the tip of the nose and another at the base of the nose.

[0020] DESCRIPTION OF THE FIGURES

[0021] Figure 1 - perspective view of the nasal dilator (1). The nasal dilator (1) comprises two tubular elements (2) connected to each other by means of a connection band (3). Each tubular element (2) further comprises two openings and three sections, wherein the first opening is located in the first section (2.1) and the second opening is located in the third section (2.3). The first opening has a larger diameter than the second opening. Each tubular element (2) comprises one protrusion (4) extending radially from the outer surface of the first section (2.1), wherein the protrusion has a pyramidal shape in which one facet of said pyramidal shaped protrusion (4) is leveled in the same horizontal plane that contains the first opening. The apex of each protrusion (4) is rounded and the pyramidal shape then declines towards the second section of the tubular element (2) in a longitudinal direction, following the natural shape of the nasal cavity. Each tubular element further comprises a plurality of ribs (5), preferably seven ribs (5) in total, extending circumferentially from the tubular element's outer surface, said ribs (5) having rounded edges, wherein two ribs (5) are positioned on the first section (2.1) below the protrusion (4), three ribs (5) are positioned on the second section (2.2) and two ribs (5) are positioned on the third section (2.3).

[0022] Figure 2 - side view of a preferred embodiment of the nasal dilator (1), wherein each tubular element (2) comprises at least two protrusions (4) extending radially from the outer surface of the first section (2.1), being said protrusions (4) diametrically opposed to one another and perpendicularly positioned in relation to the direction of the connection band (3).

[0023] Figure 3 - top view of the preferred embodiment of the nasal dilator (1), wherein the inner channel of each tubular element (2) comprises a larger diameter in the first section (2.1) and a smaller diameter in both second (2.2) and third section (2.3) respectively of said tubular element (2). The two tubular elements (2) of the nasal dilator (1) are connected by the connection band (3), wherein one side of the band is slightly larger so that the connection band (3) can be properly positioned across the nasal columella once the tubular elements (2) are positioned inside the nasal cavity.

[0024] Figure 4 - bottom view of the preferred embodiment of the nasal dilator (1).

[0025] Figure 5 - schematic presentation of the positioning of the nasal dilator (1) inside a human nasal cavity. The nasal dilator (1) is shown with full tracing, while the human nasal cavity is shown with dashed tracing. Each tubular element (2) is positioned inside the nasal cavity so that the first section (2.1) is positioned at the entrance of the nasal cavity as it is the wider section of the nasal dilator, and the second (2.2) and third section (2.3) are positioned in the progressively narrower parts of the nasal cavity in the opposite direction of the nasal cavity entrance. The connection band (3) sits across the nasal columella, preventing the tubular elements (3) to be inserted too deep inside the nasal cavity. The two diametrically opposed protrusions (4) are positioned inside the nasal cavity, one protrusion (4) facing the inner nasal cavity walls at the tip (T) of the nose, while the other protrusion (4) is facing the base of the nose nearthe anterior nasal spine of maxilla (O), thus providing two distinct blocking sites to prevent the tubular elements (2) from sliding out from the nasal cavity. The ribs (5) that extend circumferentially from the outer surface of each tubular provide additional gripping regions to the inner wall of the nasal cavity and provide means to customize the length of the tubular element (2), as the ribs (5) also determine the positions where the tubular element (2) can be cut to decrease the length of the tubular element (2). Alternatively, the length of the tubular element (2) can be shortened without any cutting procedure by collapsing and folding the space between de ribs (5) by longitudinal compression, which makes the ribs (5) to be closer together and shortens the length of the tubular element (2).

[0026] DETAILED DESCRIPTION

[0027] The more general and advantageous configurations of the present invention are described in the Summary of the Invention. Such configurations are detailed below in accordance with other advantageous and / or preferred embodiments of implementation of the present invention.

[0028] In relation to Figures 2 and 3, the preferred embodiment of the present invention is a nasal dilator (1) wherein each tubular element (2) comprising two diametrically opposed protrusions (4) for blocking involuntary movements of the nasal dilator (1) inside the nasal cavity, including sliding movements that would result in the removal of nasal dilator (1) from the nasal cavity. Preferably, the height of the protrusions (4) is between 3 and 7 mm so that each protrusion is adapted to fit the space inside the nasal cavity near the tip of the nose (T), which has a depth between 1 and 6 mm in all humans. Therefore, the height of the protrusion (4) as well as its pyramidal shape, which follows the natural shape of the inner walls of the nasal cavity, allows the nasal dilator to be fixed at the tip of the nose and / or at the rear of the nasal cavity near the anterior nasal spine of maxilla (O). In another relevant aspect of the present invention, the second section (2.2) of each tubular element has an increased thickness compared to the first (2.1) and third sections (2.3) of the same tubular element (2), as the outer radius of the second section (2.2) is the same as the outer radius of the first section (2.1) being larger that the outer radius of the third section (2.3), while the inner radius of the second section (2.2) is the same as the inner radius of the third section (2.3), being smaller that the inner radius of the first section (2.1). The increased thickness of the second section (2.2) significantly increases the central resistance against the collapsing of the tubular element (2) at the center, which is essential to maintain the air flow unobstructed at all times. In addition, the increased resistance to the collapse of the intermediate section of the tubular elements (2), along with the blocking effects of the two protrusions (4) and ribs (5), allows the nasal dilator (1) to maintain its position and resist the involuntary external forces done by the user during the sleeping period, such as nose scratching or pinching.

[0029] In a preferred embodiment of the present invention, each tubular element and connection band is made of soft materials such as thermoplastic silicone or silicone resins. These materials become softer and pliable when heated, allowing the nasal dilator (1) to be easily adjusted inside the nasal cavity by the user. While inserting the pliable nasal dilator (1) inside the nasal cavity, the protrusion (4) will hold the nasal dilator (1) in place until the thermoplastic silicone or silicone resins cooldown and the nasal dilator (1) hardens and reverts to its original shape, thus applying a pressure to the inner wall of the nasal cavity, widening the nasal canal to provide an increased nasal air flow to the user. In addition, the pressure also increases the retention of the nasal dilator (1) inside the nasal cavity together with the ribs (5) and protrusions (4) that prevent the movement of the nasal dilator (1), which is useful during intense physical activities that increase the air flow.

[0030] The nasal dilator (1) can be manufactured by injection molding into a mold or it can be 3D printed to the desired shape.

[0031] A relevant aspect of the present invention is that the materials composing each tubular element and connection band are biocompatible, wherein the materials do not have a toxic or injurious effect in the nasal epithelium. Therefore, the nasal dilator (1) being made from biocompatible materials is in contact with the nasal epithelium without causing deleterious effects in the user, such as inflammation. Another embodiment of the present invention is a nasodilator kit, comprising the nasal dilator (1) and a lubricant substance. The use of lubricants, such as ozonated oils, facilitates the insertion of the nasal dilator (1) into the nasal cavity of the user and protects the nasal epithelium when it is dry and more susceptible to damages such as irritation.

[0032] Of course, the preferred embodiments shown above are combinable, in different possible configurations, being the present invention not limited to the embodiments previously described.

Claims

CLAIMS1. A nasal dilator comprising two tubular elements connected to each other by means of a connection band, forming a single body structure, each one tubular element configured to be positioned inside a nostril of a human nose, comprising two openings and three sections, each section having a same longitudinal axis, wherein the second section is located between the first and the third section; said first section being a proximal section, said second section being an intermediate section and said third section being a distal section; characterized by the first opening being located in the first section and the second opening being located in the third section; the diameter of the first opening being larger than the diameter of the second opening; and by the thickness of the second section being larger than the thickness of the first and third sections.

2. A nasal dilator according to the previous claim wherein the ends of the connection band are attached to the first section of each tubular element so that said connection band is positioned perpendicularly to the longitudinal axis of each tubular element; and wherein each tubular element comprises at least one protrusion that extend radially from the outer surface of the first section; said at least one protrusion being perpendicularly positioned in relation to the connection band.

3. A nasal dilator according to claim 2 wherein the at least one protrusion comprises a pyramidal shape that declines towards the second section of the tubular element, wherein the apex of the at least one protrusion is rounded.

4. A nasal dilator according to claim 2 or 3 wherein each tubular element comprises two diametrically opposed protrusions.

5. A nasal dilator according to any of the previous claims wherein the at least one protrusion has a height between 3 and 7 mm.

6. A nasal dilator according to any of the previous claims wherein each tubular element comprises a plurality of ribs extending circumferentially from said tubular element's outer surface.

7. A nasal dilator according to claim 6 wherein each tubular element comprises at least seven ribs; wherein at least two of said ribs are positioned on the first section; at least three of said ribs are positioned on the second section; and at least two of said ribs are positioned on the third section.

8. A nasal dilator according to claim 7 wherein the ribs comprised in each tubular element have rounded edges.

9. A nasal dilator according to any of the previous claims wherein each tubular element and connection band are made of thermoplastic silicone.

10. A nasal dilator according to claims 1 to 8 wherein each tubular element and connection band are made of silicone resins.

11. A nasal dilator according to claims 9 or 10 wherein the materials composing each tubular element and connection band are biocompatible.

12. A nasodilator kit comprising a nasal dilator according to any of the previous claims and a lubricant substance.

Images