WO2001060294A1 - Nasal passage dilator splint - Google Patents

Abstract

A splint (1) for dilating one passage of a person's nose (31), one portion (3, 5) of the splint (1) anchored to the hard part of the nose (31), while a second portion (2, 6) of the splint (1) is anchored to the soft part of the nose (31). While both portions (3, 5 and 2, 6) have a concave profile, the splint (1) has a convex profile between the portions. The use of an applicator (20) is also disclosed.

Description

"Nasal Passage Dilator Splint"

This invention relates to a nasal passage dilator including an arrangement where a dilator is affixed to the side of a nose of a user and characteristics of a dilator.

We have been the applicants of an earlier Patent Application identified in Australia as Australian Patent No. 702632 which describes an arrangement for assisting in effecting dilation of a nasal passage.

This invention relates to improvements pertaining to that original disclosure and concept.

The original disclosure has worked effectively but it has been found that there can be improvements and it is an object of this invention then to provide improvements in relation to the original disclosed apparatus and invention.

In accordance with one form of this invention there is proposed a splint for location on and adhesion to one side of a nose only whereby to effect a dilation of a part of a nostril on that side of the nose, the splint having two parts, one of which is at one end of the splint, and the other of which is at an opposite end of the splint, the two parts defining together the shape of a splint where there is an outer face intended to be the face adhering to the nose which is providing a convex alignment and where with respect to at least one of the parts, with that same face intended to be adhering to the side of the nose, being of concave shape.

In preference, such concave shape is defined by two portions of each part, where a first portion defines approximately a first plane, and a second portion defines approximately a second plane which planes are orientated one with respect to the other so that there is a concave shape defined therebetween which is on the outer otherwise convex side of the splint.

While there has been described a preferential arrangement in which each portion of each part defines approximately a plane, nonetheless, the transition between the two portions can be a curved shape which has a large radius or a curved shape which has a small radius. It has been noticed where the splint has been divided into two portions each of which is generally planar in shape and where the angular relationship of the planes defined by the respective parts is such that on an outer side where the shape might be referred to as the convex side, then, even with different angular relationships between the parts, it is difficult over a period to maintain adhesion.

It has been difficult to ensure that a splint will continue to adhere to a person's skin over a longer period of use of the splint.

Further, in preference, while some portion can define a planar shape, it need not of itself be planar but follow a compound curved shape howbeit that a general shape can be used as an assessment to define a planar alignment.

By providing then that the splint has this more complex shape, it is found that especially at or toward each end of the splint there will then be a shape which will more closely follow and maintain uniform adhesion forces to the skin of the nose of a person using the splint.

In previous arrangements, where one part is generally planar, then the skin adhering at an outer part will have a greater tension between the splint or adhesive layer of the splint and the skin of the nose than that part of the skin which is closer to a center of the splint where "center" is generally in the direction of elongation of the splint.

This "softening" of the shape of each end of the splint provides a shape that more naturally follows an expected contour of the flesh of the side of the nose which is intended to be adhered to the splint and provides that there is not so much stress concentrations right at the end of the splint .If there is this higher stress concentration, it can mean that the flesh of the nose will start to separate and once this starts, one can understand how this then will continue to extend the separation effect.

In preference, there is provided a further feature which is that at least one end of the splint the splint is wider than at least a portion of the splint between the two ends.

Such an arrangement has the advantage that such a shape can be then used to assist in guiding a user as to an appropriate fitting position.

This allows for the respective end to be useful for location of the splint when being fitted as well as providing a larger area for adhesion to an underlying skin of a nose. In preference the increased area is in the form of a projection from one side of the splint which includes two oppositely positioned sides which are parallel one with respect to the other.

In preference this is positioned so that an appropriate location of the splint will result in the respective sides of the projection being an equal distance from the lower edge of a nostril in the case of one side and the nasal crease in the case of the other side.

In preference, both ends are broader than a central portion of the splint.

In preference, one end has a portion which abruptly changes from a narrow part of the splint to a broader part.

In a further preferred arrangement, the end of the splint intended to be located at an upper end of the nose, is broadened by the sides being tapered outwardly as they progress toward the further end.

By having such broader parts toward the end, there is the further advantage of a greater surface area for adhesion to take place and so again, individual areas of skin need not be adhering so strongly which again makes for comfort and for a better security of long term adhesive grip.

A further advantage of having an abrupt change in shape is that such an abrupt change of shape can also act as a marker to assist in locating the splint with relation to the side of the nose.

The system described intends for such a splint to be adhered to the side of a nose so one end of the splint is located so as to adhere to the skin above a harder or bonier or stronger part of the nose as compared to a lower part of the nose which is that part that is going to be pulled out to assist dilation of the nostril.

It is, of course, understood that this arrangement is in relation to a splint for the purpose of holding a nostril of a user by having the splint on one side only of the nose and it is in specific contradiction to any prior art where there is intended to be a bridge across the nose. In preference, there can be also included with the splint, an applicator which includes a tab which can be held between the fingers of an intending user, and a adhering portion which is adapted to be adhering to a portion of the splint between the two ends.

In preference, the invention can reside in the combination of such an applicator which is a splint as characterised previously.

In preference, a user will use two splints so that they are applied one to each side of the nose.

In preference, the splint is made from a plastics material with an adhesive material on the side intended to be secured to the skin adjacent the nose of a user.

In preference, with a splint being of plastics material facilitates a number of advantageous features. A first of these is that the splint can be made transparent. This assists discretion of those wearing a splint or splints.

The material can be formed by extrusion or injection molding so that parts can be of different thicknesses.

Further, a shape can be established at molding that can be resiliently deformed but will return under resilient force to the original shape for instance after attaching the splint to a vestibule of the nostril.

In preference, the plastics material is polyester.

In preference, a splint is packaged and provided with a cover covering the otherwise available contact adhesive surface.

In preference, such cover is a siliconised carrier.

In preference, the adhesive is provided by being applied as an impregnated woven fabric which is adhering on one side to the outer surface of the appropriate side of the splint, and on the other is adapted to adhere by contact to the skin of the nose for the purpose of the application.

In preference, the invention can also reside in the combination of such a splint when adhering to the nose of a person.

Further, in preference, the invention can reside in the combination of two splints as described being secured to each of a respective side of the nose of a person.

In a further form, the invention can be said to reside in a method of effecting a dilation of a nostril which comprises the steps of adhering a splint of the type described to the side of the nose of a user where the position of the splint is such that a part with an adhering face, is placed against the skin above a portion of the side of a nose of a person with a harder underneath structure, and a portion of the nostril towards its open end, is urged into an outer or dilated position to where a second part of the splint has been positioned against resilient resistance where it is positioned to be against and therefore in an adhering position with respect to the said part of the splint.

.For a better understanding of this invention it will now be described with relation to two embodiments which should be described with the assistance of drawings wherein:

FIG. 1 is a side elevation of a splint according to a first embodiment;

FIG.2 is a plan view of that same splint as shown in FIG. 1 according to a first embodiment with, however, an applicator adhering to this;

FIG. 3 is a perspective view of the applicator separate from the splint; FIG.4 is a side elevation of the shape of a splint according to a second embodiment;

FIG. 5 is a plan view of the splint as shown in the second embodiment as shown in

FIG. 4;

FIG. 6 is a perspective illustration illustrating how the splint of the first embodiment is to be applied and located relative to a nose of a user; and

FIG. 7 illustrates how the splint on one side of the user will be located once applied and with the applicator removed.

FIG.8 is a cross sectional view of a splint according to a third embodiment also including angular alignments, FIG.9 is a plan view of the third embodiment when stretched into a planar alignment,

FIG. 10 is the same view as in FIG 8 being a side view in elevation of this third embodiment showing however the location of the subsequent cross sectional views 11/11 and 12/12, FIG. 11 is the cross sectional view along the lines 11/11 of figure 10, FIG. 12 is the cross sectional view along the lines 12/12 as in FIG 10.

Referring in detail to the drawings, and in particular to the first embodiment which is shown with FIGS. 1 , 2, 6 and 7, there is a splint 1 which is either formed or molded so as to be in the shape shown which includes a first part at one end 2 and a second part at the other end 3.

The respective parts 2 and 3 generally can be said to define, in each case, an alignment or direction of elongation so that there is a relative orientation between the two parts so that overall these provide a convex shape so that the bend at 4 is greater than 180° which provides a convex alignment

In the embodiment, the two parts 2 and 3, at least on the inner side define between them an angle of 75° although this in practice has been found to be able to be varied between 60° to 80°.

As will now be seen, however, with respect to each part 2 and 3, the end in each case as shown, for instance, at 5 in the case of part 2 and 6 in the case of part 3 turn inwardly toward the outer adhesive side.

This then creates this secondary concave shape in relation to each of the parts so that there are two portions on each part defining the relative concave shape while overall, the two parts together provide a convex shape on the adhesive side.

There is shown two FIGS. 1 , a first being FIG. 1a, and a second 1b, which show a different set of angular relationships so that this splint which can be shown at 10 includes two parts 11 in the one case and 12 in the other and again, there is provided at each end, a portion 13 in the one case and 14 in the other.

Again there is shown this concave shape with each part howbeit that the two parts together form and provide a convex shape in relation to the adhesive side which is on the side shown at 15.

In connection with FIG. 1 b, the inner portion 16 of the part 11 defines a planar shape and the portion 13 is aligned at 10° to this.

The relative lengths of these two portions are 11 mm for the inner portion 16 and 4mm for the outer portion 13. For the other part 12, there is an inner portion 17 which is 6mm in length and this is offset to the planar alignment of the inner portion 17 by 40°.

In both cases, the planar shape looks very similar to that shown in FIG.2 in which there are extended wings at each side, these shown at 18 and 19 in the one case and there is a broadening of the end at 5 so that whereas the width of the splint in a location between the two ends is 6mm this broadens out by a further 2mm to each side at the location of the portion 5.

The middle location at 18 then is used to support an applicator 20 which includes an adhesive underneath surface at its end 21 which simply assists a user to locate the splint 1 in an appropriate location.

It is the convex alignment that is useful to align the splint for fitting on the nose. This convex alignment is an alignment which is transverse to a direction of elongation of the splint so that it will nest in a crease which exists on both sides of the nose. This then enables the splint to be positioned with this nesting location being used to guide to its overall position with respect to the nose. This makes positioning of a single sided splint easier for a user.

In practice the same procedure is repeated for each side of the nose although the splints on each side are not connected.

Now referring specifically to FIGS. 6 and 7, it will be seen that the splint 1 is first located by the hand of the user shown at 30 where the nose 31 is to support the splint so that the portion 5 is uppermost and is to be located together with the portion 3, so that it will adhere to the skin of the nose where there is located immediately beneath this, cartilage which is found in practice to provide a solid foundation on which the splint can be firmly located and act in a cantilever manner to support a remainder of the splint.

The location for a user is of significant advantage if this has got absolutely accurately and accordingly, by use of the applicator 20, it is easier to locate the wing portion 6 so that it is closely positioned midway between a crease 32 in the nose and the bottom edge of the nasal passage at 33.

There is further significant advantage in the choice of materials where these can be chosen from materials that are clear or relatively translucent and we will therefore reflect the natural hue and colour of the skin and therefore not be so apparent to any external observer.

This in fact is a significant advantage of the arrangement as compared to any device that bridges across the nose where these will be much more apparent.

The second embodiment which is shown in FIGS. 4 and 5 is shown where the splint 40 has two parts 41 and 42 both of which again are such as to provide an external face which is generally of concave shape but overall define together a convex shape with respect to the adhesion side which is 43.

An end portion 44 of the part 41 is aligned at approximately 40° to the planar alignment of an inner portion 45.

The angular relationship between this inner portion 45 and the inner portion 46 is in this embodiment 75° but it is found that this can be varied between 60° to 80° and more if needed.

The outer portion 47 of the part 42 is aligned at 10° to the planar alignment of the inner portion 46.

The difference here is that the overall width is constant throughout the length of the splint and this has the advantage of providing an additional area of adhesive surface but is not quite so subtle in its appearance.

It can be noted generally in the embodiments that a paper liner is provided over the contact adhesive which is to be removed prior to fitting.

The adhesive itself is chosen as to be a contact pressure sensitive hypoallergenic adhesive coated on a breathable non-plastic supporting double sided tape.

The strip in each case is made from .010 inches polyester.

In fitting the splint the user will first locate the splint so that the convex part of the splint is positioned so as tin one instance will use a forefinger and thumb to grasp the outer flap or vestibule on one side of the nose and an outer side of the nostril to urge the outer flap or vestibule of the nasal passage outwardly so as to bring this into contact with the adhesive surface of the splint. Thereafter, its natural returning pressure will cause the splint to slightly bend and conform more naturally to the overall shape of the nose without this looking substantially out of place.

This third embodiment is molded from polyester plastics material and is chosen so that it will be molded to take the shape as shown in FIG 8 except that it can be resiliently deformed so that it will offer some return springing type or resilient tension.

Firstly describing the characteristics of the third embodiment, there are two parts 50 and 51.

These two parts generally define planes which in this case are approximately 95° orientated one with respect to the other.

At the respective ends of the parts there are portions which are turned over these being shown at 52 in the one case and 53 in the other which of themselves can be considered to be generally defining a planar alignment given however that they do in fact follow a compound curve although referenced to a "plane" in a relatively illustrative way can be understood and can be seen from the drawing to be reasonably identifiable in orientation angle.

The result then for each part is that the outer side in both cases provides a concave shape which then is chosen both to appropriately align with the relevant parts of the nose surface and also to assist in reducing any tension separation pressures at the outermost ends of the part.

Another factor with the splint shown is that it shall require to provide a resilient tension.

To assist in the developing an appropriate shape and choosing an appropriate plastic, information as to the extent of resiliency found appropriate in this embodiment will now be given.

For instance, the pressure applied to the end of the part that is at 53 while part 50 was anchored, to divert this so that the main part 51 which shows an initial alignment at 95° is bent around to 76° requires 8 grams in this embodiment, 22 grams with 57° deflection, 30 grams for 38° deflection, 47 grams for 19° deflection, and 53 grams for 0° deflection all of these being relative to the first part 50. When the splint is to be used, this part is caused to bend and is brought down into contact with a lifted vestibule of nose so that there is maintained a tension against the relevant part of the nose.

Referring now to FIG 9, this shows a splint 56 which has two parts 57 and 58 which are separated generally by a bend at 59.

At a lower end of the part 58 is a an outer projection 60 which has two parallel defining sides at 61 and 62 which are also directly transverse to the direction of elongation of the splint 56.

It is these two parallel perimeter edges 61 and 62 that are useful in aligning the splint on a nose.

This is achieved by providing that the respective parallel perimeters are positioned so as to be in each case an approximately equal distance from in the case of edge 61 , the nasal crease, and in the case of 62, the lower edge of the nasal passage.

This can both assist visually by a intending user and easily explained.

Dimensions of the projection are of relevance in so far that the location and distance are part of the two edges are not coincident with the nasal crease or the lower edge as these would then potentially interfere with the way the splint works or it would become more visually obvious.

An appropriate distance apart of the two parallel edges has been found to be 4 mm and the projection from the otherwise parallel side 63 is also then 4 mm.

This 4 x 4 mm "boot" then provides this advantage described.

It is of relevance that the overall length of the splint 56 is 26 mm and generally is found to be better not to be longer then 28 mm.

The width for instance at 64 is 6 mm and the main bend 59 is 10 mm from the edge 64 and 12 mm from the edge 62.

The degree of curvature as shown in FIG 11 and FIG 12 is selected so as to provide additional correspondence of the engaging surface of the splint with the shape of the nose and can be adjusted accordingly as greater experience illustrates what is most appropriate.

In this third embodiment, the plastics material is molded 200 micron polyvinyl chloride and adhesive which is identified as a 3M1522 has been used. This material was heated for 30 seconds at 130°C and it provides the appropriate resiliency and flexibility useful in this application.

As can now been seen, the splints being proposed and the method of application provides significant advantages.

Claims

1. A splint for location on and adhesion to one side of a nose only whereby to effect a dilation of a part of a nostril on that side of the nose, the splint having two parts, one of which is at one end of the splint, and the other of which is at an opposite end of the splint, the two parts defining together the shape of a splint where there is an outer face intended to be the face adhering to the nose which is providing a convex alignment and where with respect to at least one of the parts, with that same face intended to be adhering to the side of the nose, being of concave shape

2. A splint as in claim 1 further characterised in that both parts have an outer face arranged so that the shape intended to adhere against the side of the nose define a concave shape.

3. A splint as in claim 2 further characterised in that such concave shape is defined by two portions of each part, where a first portion approximately defines a first plane, and a second portion approximately defines a second plane which respective planes are orientated one with respect to the other so that there is a concave shape defined therebetween which is on the outer otherwise convex side of the splint.

4. A splint as in any one of the preceding claims further characterised in that each portion of each part defines a plane with the transition between the two portions being a curved shape.

5. A splint as in any one of the preceding claims further characterised in that each referred to plane is defined by a compound curved shape.

6. A splint as in any one of the preceding claims further characterised in that at least one end of the splint is wider at least in part, than at least a portion of the splint between the two ends.

7. A splint as in any one of the preceding claims further characterised in that both ends of the splint are broader than a central portion of the splint.

8. A splint as in any one of the preceding claims further characterised in that one end of the splint has a portion which abruptly changes from a narrow part of the splint to a broader part.

9. A splint as in any one of the preceding claims further characterised in that the end of the splint intended to be located at an upper end of the nose, is broadened by being tapered outwardly as it progress's toward the further end.

10. A splint as in any one of the preceding claims further characterised in that it is in position with a nose being adhered to a side of the nose so one part of the splint is located so as to adhere to the skin above a harder or bonier part of the nose and the further part is that is going to be pulled out to assist dilation of the nostril.

11. A splint as in any one of the preceding claims further characterised in that it is made from a plastics material with an adhesive material on the side intended to be secured to the skin adjacent the nose of a user.

12. A splint as in the immediately preceding claim further characterised in that the plastic is polyester.

13. A splint as in any one of the preceding claims further characterised in that it is packaged and provided with a cover covering the otherwise available contact adhesive surface.

14. A splint as in the immediately preceding claim further characterised in that the cover is a siliconised carrier.

15. A splint as in any one of the preceding claims further characterised in that the adhesive is provided by being applied as an impregnated woven fabric which is adhering on one side to the outer surface of the appropriate side of the splint, and on the other is adapted to adhere by contact to the skin of the nose for the purpose of the application.

16. A splint as in any one of the preceding claims further characterised in that there is with the splint, an applicator which includes a tab which can be held between the fingers of an intending user, and a adhering portion which adheres to a portion of the splint between the two ends of the splint.

17. IA combination of such an applicator with a splint as in any one of the preceding claims.

18. A method of effecting a dilation of a nostril which comprises the steps of adhering a splint of the type described to the side of the nose of a user where the position of the splint is such that a part with an adhering face, is placed against the skin above a portion of the side of a nose of a person with a harder underneath structure, and a portion of the nostril towards its open end, is urged into an outer or dilated position to where a second part of the splint has been positioned against resilient resistance where it is positioned to be against and therefore in an adhering position with respect to the said part of the splint.