GB2616634A

GB2616634A - Nasal dilator

Info

Publication number: GB2616634A
Application number: GB2203585.1A
Authority: GB
Inventors: Wiffen Richard; Thomas Joshua
Original assignee: ARIA HEALTHCARE Ltd
Current assignee: ARIA HEALTHCARE Ltd
Priority date: 2022-03-15
Filing date: 2022-03-15
Publication date: 2023-09-20
Also published as: GB202203585D0

Abstract

A nasal dilator 10 having a central body 12 from which first and second deformable members 14,16 extend, wherein the central body has first and second retaining members 20, 22 which can retain the respective first and second deformable members in a deformed configuration. Also disclosed is a method of treating snoring and/or obstructive sleep apnea via use of the nasal dilator. The deformable members 14, 16 may; comprise a first and second material, the first being harder than the second and encapsulated by the second material; and may comprise elongate wings extending from the central body diametrically opposite one another, the wings being connected to, or formed with, the central body. The retaining member 20, 22 may comprise an aperture or locking mechanism, the locking mechanism being either an integrated rack and ratchet within a small open case, or, a twist slide and lock mechanism. The nasal dilator may be manufactured from a thermoplastic elastomer.

Description

Nasal Dilator The present invention relates to devices for preventing or reducing snoring and/or Obstructive Sleep Apnea (OSA). In particular, the present invention is concerned with nasal devices, more particularly, nasal dilators.

Snoring and OSA are associated conditions with heavy snoring being a common indicator of the presence of OSA. Snoring is caused by air turbulence resulting from the vibration or disruption of the tissue and structure of the upper airway. Such disruption of the tissue and structure of the airway may extend to the point of causing multiple events of closure or obstruction of the upper airway characteristic of OSA.

Snoring is often a source of sleep disruption to the bed partner of the snorer resulting in impairment of sleep and relationship. In the long-term snoring, even when not immediately associated with the presence of OSA, may cause inflammation, swelling and damage to the tissue of the upper airway that may in turn encourage the development of OSA. Reduction in snoring is of benefit to both the sufferer and the bed partner and where that snoring is a precursor or indicator of OSA there is an imperative to seek treatment.

There are various alternative treatments offered to manage the snoring condition with various evidence of success. Oral devices with a mechanism for mandibular advancement acting on the muscles supporting the airway to physically sustain airway patency include W02017/006129.

Other approaches have been to maintain the nasal passages. Examples of such devices include EP1033118A1 and WO9423675A1.

These nasal dilators tend to rely on devices that are clamped to the nasal septum or over-sized devices intended to apply pressure on the inside of the nostril to open the airway.

These known nasal devices are limited by the standardized sizing and uniformity of the elements of the device intended to be received by the nasal passages. As can be appreciated, respective nasal passages of an individual will not have uniform diameter and cross-section. This can lead to an uncomfortable experience for a user when wearing known nasal dilators or a poor fit, resulting in dislodgment of the device during sleep leading to the collapse of the nasal airways and as a consequence OSA and/or snoring. Advantageously, the present invention alleviates or overcomes one or more of the problems associated with the prior art.

In accordance with a first aspect of the present invention there is provided a nasal dilator comprising a central body from which extend a first and a second deformable member, wherein the central body has first and second retaining members for retaining respective first and second deformable members in a deformed configuration, and wherein the deformable members can be deformed and retained in the deformed configuration by the retaining members.

Advantageously, the deformable members are resiliently deformable such that they assume their non-deformed configuration when not retained by the retaining members. More advantageously, the deformable members are elongate so that a broad range of deformed configurations can be achieved to facilitate use by users with nasal cavities ranging from small to large.

Advantageously the retaining members may retain the deformable members in an infinite number of configurations.

Advantageously, the deformable members may be deformed and may be passed through or adjacent to the retaining members to be maintained in the deformed configuration.

Advantageously, the retained deformable member forms a configuration which acts on the nasal cavity to engage with and/or expand the soft tissue of the nasal cavity.

Advantageously, at least a portion of each deformable member is intended to be received in the nasal cavity of a user.

Advantageously, the central body and deformable members are formed from a single piece of flexible material.

Advantageously, the nasal dilator may be manufactured from a single thermoplastic elastomer or a combination of polymeric materials. The nasal dilator may comprise at least two materials, the first material being harder than a second material.

The retaining member may comprise any one or more of an aperture, locking mechanism or the like. The locking mechanism may comprise a combination or single mechanical design or feature or an interference fit. Advantageously, the locking mechanism may comprise an integrated gear rack, and, a ratchet within a small open case, or alternatively, a twist, slide and lock mechanism.

The deformable members may each comprise an elongate wing extending from the central body diametrically opposite one another.

Advantageously, the central body is intended to fit or rest under the base of the nasal septum and two deformable members can each be configured into a loop or other shape that fits into the nasal passage, the configuration maintained by passing the end of each respective deformable member through an aperture or other mechanism disposed in the central body such that each loop or shape is adjustable in size to engage with and or expand the soft tissue of the nasal cavity.

Each elongate wing may be formed with or connected to the central body. Advantageously, each elongate wing is integrally formed with the central body by means of two arms that serve to redistribute and/or decrease the force necessary to deform the elongate wing and arms into the looped conformation.

The present invention will now be described by way of example only with reference to the accompanying drawings, in which: Fig. 1 shows a device in accordance with the present invention; Figs. 2 a and b show the device of Fig. 1; and Fug. 3 shows the device of Fig. 1 in a deformed configuration.

Fig. 1 shows a nasal dilator 10 having a central body 12 and first and second elongate wings 14,16 extending longitudinally away from the central body along the longitudinal axis of the central body 12 and diametrically opposite one another.

A central portion 18 of the central body 12 is intended to be received under the nasal septum of a user either side of which are first and second retaining members 20, 22 each in the form of an aperture.

Elongate members 14, 16 each have a free end 24, 26 that are shaped to be able to be received by apertures 20, 22 in use.

Each of the first and second elongate wing is integrally formed with the central body 12 by means of two arms 28, 30 and 28', 30' respectively, that serve to decrease and/or redistribute the force necessary to deform the elongate wing and arms into the looped conformation. The cut outs 28 30 act to spread evenly the force exerted by the wings across the section of nasal tissue that is most prone to inflammation in a comfortable and effective way Figs. 2 a and b show a side elevation of the device where it can be seen that the central portion 18 has effectively a U-shaped body to accommodate the nasal septum to improve fit and comfort. Fig. 2 b shows one of the elongate wings 14, 16 deformed and the thickening of the side wall 40, 42 of the elongate wing proximal to the central portion. The thickening provides for greater longevity of the product and structural integrity when the wings are located in and retained by the retaining members.

Fig. 3 shows the device where the wings have both been deformed and the free ends passed through the retaining embers, namely apertures 20, 22, to form a looped configuration.

The device may now be inserted into the nasal cavity at which point the free ends of the wings can be displaced further to alter the shape of the loops formed by the deformed wings which are intended to contact the inside surface of the nasal cavity and thereby prevent their collapse. Each wing is infinitely adjustable to conform to the nasal cavity of an individual and the device accommodates nasal cavities that may differ in size from one individual to another.

While the present invention has been described as having exemplary designs, the present invention may be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

Claims

CLAIMS1.A nasal dilator comprising a central body from which extend a first and a second deformable member, wherein the central body has first and second retaining members for retaining respective first and second deformable members in a deformed configuration, and wherein the deformable members can be deformed and retained in the deformed configuration by the retaining members.
2. A nasal dilator as claimed in claim 1 wherein the retained deformable member forms a configuration which acts on the nasal cavity to engage with and/or expand the soft tissue of the nasal cavity in use.
3. A nasal dilator as claimed in claim 1 or 2 wherein the nasal dilator is manufactured from a thermoplastic elastomer.
4. A nasal dilator as claimed in any previous claim wherein the deformable members comprise resiliently deformable material.
5. A nasal dilator as claimed in claim 4 wherein the central body and deformable members are formed from a single piece of resiliently deformable material.
6. A nasal dilator as claimed in any one of the previous claims wherein at least the deformable members comprise a first and a second material, the first being harder than the second.
7. A nasal dilator as claimed in claim 6 wherein the first material is encapsulated by the second material.
8. A nasal dilator as claimed in any previous claim wherein each retaining member comprises any one or more of an aperture and/or locking mechanism.
9. A nasal dilator as claimed in claim 8 wherein each retaining member comprises a combined aperture and locking mechanism.
10. A nasal dilator as claimed in claim 8 or 9 wherein any locking mechanism comprises a combination or single mechanical design or feature, and/or an interference fit.
11. A nasal dilator as claimed in claim 8, 9 or 10 wherein the locking mechanism comprises an integrated gear rack, and, a ratchet within a small open case, or alternatively, a twist, slide and lock mechanism.
12. A nasal dilator as claimed in any previous claim wherein the deformable members each comprise an elongate wing extending from the central body diametrically opposite one 20 another.
13. A nasal dilator as claimed in claim 12 wherein each elongate wing is formed with or connected to the central body.
14. A nasal dilator as claimed in claim 13 wherein each elongate wing is integrally formed with the central body by means of two arms that serve to redistribute and/or decrease the force necessary to deform the elongate wing and arms into the looped conformation.
15. A nasal dilator as claimed in any previous claim wherein the central body is intended to fit or rest under the base of the nasal septum and two deformable members can each be configured into a loop or other shape that fits into the nasal passage, the configuration maintained by passing the end of each respective deformable member through an aperture or other mechanism disposed in the central body such that each loop or shape is adjustable in size to engage with and or expand the soft tissue of the nasal cavity.
16. A method of treating snoring and/or obstructive sleep apnea comprising the use of a nasal dilator as claimed in any one of the previous claims.