WO2020039095A1

WO2020039095A1 - Nasal apparatus and method of drug delivery using said nasal apparatus

Info

Publication number: WO2020039095A1
Application number: PCT/EP2019/072644
Authority: WO
Inventors: Martin O'connell; Keith Yeager
Original assignee: Nasal Medical Limited
Priority date: 2018-08-24
Filing date: 2019-08-23
Publication date: 2020-02-27

Abstract

The present invention relates to a nasal apparatus which improves respiration by expanding the nasal airways and preferably, the apparatus comprises a filter to block irritating or harmful particles. The apparatus of the present invention is preferably, configured to retain the filter on the apparatus while providing comfort for the user to wear the apparatus. In another aspect of the present invention, the invention also relates to a method of delivering a therapy intradermally or intramucousally including a therapy such as a medicament including drug delivery, delivery of essential oils or any desirable therapy that can be delivered intradermally or intramucousally through the nasal mucous membranes.

Description

NASAL APPARATUS AND METHOD OF DRUG DELIVERY USING SAID

NASAL APPARATUS

Field

The present invention relates generally to a nasal apparatus which improves respiration by expanding the nasal airways and preferably, the apparatus comprises a filter to block irritating or harmful particles. The apparatus of the present invention is preferably, configured to retain the filter on the apparatus while providing comfort for the user to wear the apparatus. In another aspect of the present invention, the invention also relates to a method of delivering a therapy intradermally or intramucousally including a therapy such as a medicament including drug delivery, delivery of essential oils or any desirable therapy that can be delivered intradermally or intramucousally through the nasal mucous membranes.

Background of The Invention

Respiratory issues result from a number of conditions, ranging from

comparatively simple ones like congestion to more difficult ones like sleep apnea. To address these concerns, a number of products have been

developed. Generally, these products are chemical based (e.g. sprays and medicine) or structural based (dilators and filters); the present invention concerns itself with the latter grouping. Placed in a person's nostrils, such devices improve breathing by expanding the nasal airways and filtering out foreign bodies which normally irritate and agitate a person's nose. The present invention improves upon these basic principles by providing an apparatus which can be used with or without a filter.

Summary of the Invention

Accordingly, a first embodiment of the application provides a nasal apparatus as detailed in claim 1. The application also provides a method of drug delivery as detailed in the subsequent independent claim of the appended claims. Advantageous embodiments of the present invention are set out in in the dependent claims.

The apparatus of the present invention is adaptable to different nostril sizes unlike many existing products which must be sold in different sizes to

accommodate individual differences.

The present invention has an anatomic design influenced by 3D morphology. Existing products are simple geometries or only based on the 2D profile of the nasal opening, and are often closed profile which limits their ability to conform to a wide range of nostril sizes. The present invention is modeled on the 3D surfaces of the nasal geometry and incorporates features for maintaining a comfortable fit for a wide range of size variation from one user to the next. The current drawings show a device suitable for Type I & II nostril types, and alternate orientations of the device can be manufactured with proportions suitable for Type III & V, for Type VI & VII, and for Type IV.

Greater range of nostril size variation within a Type set, for example set I & II, is achieved by incorporating individual arms which allow flexibility in key anatomic locations. The length of the arms and the nature of the open profile design allow the device to conform to the individual user’s nostril. The profile cross section of the arm (generally oval shaped) is designed to allow bending along its thin dimension, while maintaining a relatively larger area of contact in its long dimension. The larger area of contact, thin bending profile, and long beam length reduce the pressure applied by the device when inserted into a relatively smaller nostril.

The profile is anatomically influenced and has three arms. They merge on the medial side of the nostril and form the largest contact area at the septal cartilage, which is relatively planar. One arm extends in the anterior direction, following the structure of the major alar cartilage. A second arm extends in the posterior direction and follows the curvature of the alar fibrofatty tissue structure. A third arm extends superior and arcs around to an inferior

orientation, terminating near the posterior portion of the major alar cartilage.

The three arms serve to dilate the nasal cavity by acting on these structures. The flexibility of the device within and between each arm is primarily in the medial/lateral direction, and secondarily in the anterior/posterior direction. While one configuration of the present invention is described with three arms, a fourth arm may also be included for additional locational stability

The present invention acts to reduce respiratory exposure to viruses, allergens, germs, flu's, colds, bacteria, molds, dust, pet dander, pollen, pollutants, contaminants, second hand smoke, carcinogens, and other airborne

contaminants. The present invention also acts to improve sleeping by

increasing nasal airflow and mitigating or eliminating snoring, headaches, and nausea. An additional benefit of the present invention is increased oxygen intake and nitric oxide production, desirable to persons who want to enhance their athletic performance.

The structure of the apparatus of the present invention may comprise a soft thermoplastic, or low modulus of elasticity, such as low or medium density polyethylene or alternately a thermoplastic elastomer such as pebax, polyvinyl alcohol, or a thermoplastic urethane.

The apparatus of the present invention preferably comprises a skirt, integrally formed on the legs of the apparatus. The skirt is of particular advantage during the manufacturing process for manufacturing the apparatus of the present invention, in particular, when forming by overmolding the dilator structure onto the membrane filter. With this approach to integrating the filter into the structure of the apparatus, a roll of filter material is fed in between mold halves in their open state. The mold halves close and the polymer is injected, thereby forming the structure onto the filter material. After ejection from the mold, there is a subsequent trimming step needed to separate the device from the continuous roll. As a result of the trimming process, there can be fiber ends that remain exposed at the edges of the filter. A user may experience

discomfort / irritation if these fiber ends contact the inner surface of the user’s nostril(s) and apply pressure to the inner surface of their nostril(s). In order to prevent loose fibers which would have such undesirable impact for a user, the may be encapsulated by a thin layer of polymer during the overmolding process. This layer is marginally thicker than the filter thickness. This skirt feature is preferably, overmolded with a larger section than will remain in the final product so that the trimming step in the manufacturing process will remove a portion of it. The advantageous end result of this manufacturing process is encapsulated fibers on the periphery of the device, thereby providing a smooth surface on the periphery of the device and a comfortable presented for the user.

The orientation of this skirt feature is also of importance. For example, if it extended outwards, (perpendicular to the dilator's peripheral footprint) a sharp edge would press directly into the nostril surface causing discomfort. For maximum comfort for the user, the skirt is oriented so as to extend in a tangential direction to the nostril surface. This way the bottom / trimmed surface of the skirt is not in contact with the nostril. Additional flexibilty / conformability of the skirt is enabled by creating a small notch on the inside of the profile.

In some embodiments of the present invention, the device includes a filter which may comprise a membrane filter. The membrane filter may be constructed of a nonwoven thermoplastic such as polyethylene, nylon, or polypropylene. It may also consist of electrospun nanofibers from materials such as polyacrylonitrile, polyvinylpyrrolidone, polyurethane, polyimide, polyethylene, etc. or any combination of meltblown, woven, and electrospun fibers.

In some embodiments, the filter may comprise a foam filter; and the foam filter may comprise a compliant open cell foam such as polyurethane or silicone. The foam filter may fill the volumetric space defined by the arms of the apparatus. The apparatus may comprise means for holding the foam filter within the space defined by the arms of the apparatus; preferably, the means for holding the foam filter comprise at least one tab provided on the apparatus, preferably, provided on the skirt of the apparatus.

It is to be understood that in some embodiments, the filter of the apparatus may comprise a membrane filter; while in other embodiments, the filter may comprise a foam filter. It is also to be understood, that in some embodiments, the apparatus of the present invention may comprise a first filter and a second filter, preferably, the first filter comprising a membrane filter and the second filter comprising a foam filter.

Any of the first filter and the second filter and any other additional filters that may be comprised in the apparatus in alternative embodiments, may include additives such as activated carbon, or anti-microbial additive or anti-microbial treatment.

Brief Description Of The Drawings

The present application will now be described with reference to the accompanying drawings in which:

FIG. 1 is a perspective view of an insert of the present invention.

FIG. 2 is a front view of an insert of the present invention.

FIG. 3 is a right view of an insert of the present invention.

FIG. 4 is a top view of an insert of the present invention.

FIG. 5 is a perspective view of an alternative insert configuration of the present invention.

FIG. 6 is a front view of an alternative insert configuration of the present invention. FIG. 7 is a right view of an alternative insert configuration of the present invention.

FIG. 8 is a top view of an alternative insert configuration of the present invention.

FIG. 9 is a front view showing a compression process of the insert once positioned in the nostril.

FIG. 10 is a right view showing a compression process of the insert once positioned in the nostril.

FIG. 11 is a top view showing a compression process of the insert once positioned in the nostril.

FIG. 12 is a perspective view showing a pair of inserts attached by a bridge of the present invention.

FIG. 13 is a perspective view showing a filter attached to the insert of the present invention.

FIG. 14 is another perspective view showing a filter attached to the insert of the present invention.

FIG. 15 is a bottom perspective view showing a filter attached to the insert of the present invention.

FIG. 16 is a top view showing a filter attached to the insert of the present invention.

FIG. 17 is a perspective view indicating how a bridge would attach two inserts, including filters, of the present invention.

FIG. 18 is a perspective view of an alternative embodiment of the insert of the present invention.

FIG. 19 is a rear perspective view of an alternative embodiment of the insert of the present invention.

FIG. 20 is a rear view of an alternative embodiment of the insert of the present invention.

FIG. 21 is a left view of an alternative embodiment of the insert of the present invention. FIG. 22 is a front view of an alternative embodiment of the insert of the present invention.

FIG. 23 is a top view of an alternative embodiment of the insert of the present invention.

FIG. 24 is a right view of an alternative embodiment of the insert of the present invention.

FIG. 25 is a bottom view of an alternative embodiment of the insert of the present invention.

FIG. 26 is a perspective view of an alternative embodiment of the insert and filter of the present invention.

FIG. 27 is another perspective view of an alternative embodiment of the insert and filter of the present invention.

FIG. 28 is a perspective view of an alternative embodiment of the present invention having an anatomic design influenced by 3D morphology.

FIG. 29 is a front elevational view of the alternative embodiment having an anatomic design.

FIG. 30 is a rear elevational view of the alternative embodiment having an anatomic design.

FIG. 31 is a right side elevational view of the alternative embodiment having an anatomic design.

FIG. 32 is a left side elevational view of the alternative embodiment having an anatomic design.

FIG. 33 is a top plan view of the alternative embodiment having an anatomic design.

FIG. 34 is a bottom plan view of the alternative embodiment having an anatomic design.

FIG. 35 is a perspective view of the alternative embodiment having an anatomic design being positioned within a nostril and having a bridge.

FIG. 36 is a perspective view of the alternative embodiment having an anatomic design being positioned within nostrils, wherein the nasal insert is connected a subsequent nasal insert by the bridge. FIG. 37 is a perspective view of the alternative embodiment having an anatomic design, wherein a filter is connected to the nasal insert.

FIG. 38 is a perspective view of another alternative embodiment having an anatomic design, wherein an additional leg is attached to the hub.

FIG. 39 is a right-side view of the alternative embodiment having an anatomic design and an additional leg.

FIG. 40 is a bottom plan view of the alternative embodiment having an anatomic design and an additional leg.

FIG. 41 is a perspective view of the yet another alternative embodiment having an anatomic design, wherein the arched legs spiral.

FIG. 42 is a front view of the alternative embodiment having an anatomic design, wherein the arched legs spiral.

FIG. 43 is a top plan view of the alternative embodiment having an anatomic design, wherein the arched legs spiral;

Figure 44 is a top plan view of an alternative embodiment of a filter device in accordance with the present invention comprising a skirt around the periphery of the filter device. The skirt is a continuation of the material comprising the dilator structure and is a relatively thin profile intended to encapsulate the fibers of a porous filter around the perimeter of the device. The filter device in this embodiment may also comprise a tab on the inside of the device to allow for incorporation of a volumetric filter;

Figure 45 is a side view of the filter in the embodiment shown in Figure 44 including the membrane filter comprising a thin border around the perimeter of the device, the border defining a skirt. The skirt encapsulates the membrane filter and prevents irritation of the nostril from loose, frayed fibers of the filter membrane; The skirt directs the filter in a downward direction to minimize contact pressure of the edge of the device. A small notch where the skirt meets the main structural member allows for a more comfortable, contoured and controlled bending of the skirt when the device is installed within the nostril, whereas a sharp transition would result in a sharp fold and uncomfortable edge.

Figure 45 also shows a cross section view of device including the structure and the membrane filter. Figure 45 shows extended skirt section on lower portion that encapsulates the filter membrane and provides a smooth compliant surface against the nostril, when in use. A recessed notch behind the skirt allows additional deflection and reduces local stiffness.

Membrane filter may also include additives for additional filtration capability eg activated carbon, anti microbial coatings, essential oils, etc

Figure 46 shows an alternative view of the device in the embodiment of Figures 44 and 45;

Figure 47 shows an alternative view of the device in the embodiment of Figures 44, 45 and 46;

Figure 48 is a perspective view of an alternative embodiment of the device shown in Figures 44 to 47; in this embodiment in Figures 48 to 50, the device includes the skirt located only on the arms of the structure (not around the entire perimeter of the filter membrane). The inclusion of the skirt in this embodiment shown in Figures 48 to 50 allows compressive flexibility while maintaining the aforementioned benefits in key pressure areas of the device; Greater range of flexibility between arms is enabled from a completely disjointed / free end, while the skirt is maintained at the perimeter of each arm.

Figure 49 is a plan view of a further alternative embodiment which is similar in structure to the embodiment shown in Figure 48, but with tabs which are provided on the main structure to retain a volumetric filter within the structure, ie any porous, compliant material for example reticulated foam (polyurethane, polyethylene, silicone rubber,... ). Foam may also contain additives for additional filtration (eg activated carbon, anti microbial coatings, essential oils, etc)

Figure 50 is an alternative view of the embodiment shown in Figure 49 with the filter membrane shown in Figure 50;

Figure 51 is an alternative view of the embodiment shown in Figures 49 and 50 with the tabs included; and

Figure 52 is a further view of the embodiment shown in Figures 49 to 51 including the tabs; A volumetric filter (e.g. foam) is installed and retained between the tabs and the dilator apparatus structure.

Figure 53 is a cross section of combination filter including a membrane filter and a volumetric filter

Figure 54 is a view of a membrane filter;

Figure 55 is a view of a volumetric filter; and

Figure 56 is a view of a volumetric filter; the volumetric filter may be combined with a membrane filter;

Figure 57 and Figure 58 are views of the nasal filter device of the present invention with the bulk material absorbing a drug for loading, for example Pebax or Ethyl Vinyl Acetate, and the drug is released via diffusion into the nasal membranes when the nasal filter device is inserted in the nostrils in use;

Figures 59 and 60 show an alternative arrangement for drug delivery in which thebulk material absorbs drug for loading, and the drug is released via diffusion, however only the bridge section of the device is loaded. This arrangement is particularly useful for delivery of aromatic compounds as it avoids having the drug in direct contact with mucous membranes (This is useful for delivery of scented oils, etc)

Figures 61 and 62 show an alternative arrangement in which the bulk material absorbs drug for loading, and the drug is released via diffusion, however only the bridge section is loaded for delivery of the drug; In this embodiment, the device is shown with filter; in this embodiment, the drug delivery operates in the same way as in Figures 59 and 60 but in this embodiment, the device includes a filter;

Figures 63 and 64 show an alternative arrangement in which the bridge section of the device comprises drug absorbent material for loading/release. The drug absorbent material can be a wicking material (cloth, fabric, sponge ,foam, etc). This is advantageous in that the drug / scented oil can be loaded directly onto wicking portion of device;

Figure 65 shows a similar embodiment to that shown in Figures 63 and 64 with the bridge section comprising drug absorbent material for loading/release (The embodiment shown in Figure 65 is the same arrangement as that shown in Figures 63 and 64, but with filter included);

Figure 66 and Figure 67 shows the filter loaded with drug for delivery through the nasal mucous membranes;

Figure 68 shows an exploded view of the arms of the device dip-coated with drug and releasable when in contact with the mucous membranes;

Figure 69 shows the device coated with drug, releaseable when in contact with mucous membranes (filter not included); Figure 70 shows the device coated with drug, releaseable when in contact with mucous membranes (filter included);

Detailed Descriptions Of The Invention

All illustrations of the drawings are for the purpose of describing selected versions of the present invention and are not intended to limit the scope of the present invention.

The present invention is a nasal apparatus which is placed in the nostril in order to provide several respiratory benefits. An insert of the present invention comprises a hub and a plurality of arched legs, with the plurality of arched legs being connected around the hub. The plurality of arched legs, in combination with the hub, give the present invention an elliptical dome-shaped appearance. Each of the plurality of arched legs comprises a free end. When inserted into a nostril, the free end of each of the plurality of arched legs presses against the interior surface. A resulting opposing force pushes the connected hub in the opposite direction, causing the nostril to expand due to the forces of the plurality of arched legs and the hub. This configuration and resulting nostril expansion is a core aspect of the present invention, as the increased airway enhances breathing and mitigates related issues such as snoring. The insert, with and without filter, is illustrated in FIG. 1 - FIG. 17.

Greater range of nostril size variation within a Type set, for example set I & II, is achieved by incorporating the plurality of arched legs which allow flexibility in key anatomic locations. The length of the each of the plurality of arched legs and the nature of the open profile design allow the device to conform to the individual users nostril. The profile cross section of each leg (generally oval shaped) is designed to allow bending along its thin dimension, while maintaining a relatively larger area of contact in its long dimension. The larger area of contact, thin bending profile, and long beam length reduce the pressure applied by the device when inserted into a relatively smaller nostril.

The free end of each of the plurality of arched legs comprises a foot. The foot is preferably arc shaped in a way that forms a radial perimeter to the hub, as shown in FIG. 1 - FIG. 4. The foot provides a greater surface area which can disperse pressure across with the nostril interior and thus provide a more comfortable experience for a user.

Preferably, also in the interest of ergonomics, the edge of each foot is smooth and rounded.

In the preferred embodiment the plurality of arched legs comprises a first leg, a second leg, a third leg, and a fourth leg each of which are flexible bars that are radially positioned around the hub. The legs are equally spaced around the hub such that each that the free end of any given leg is separated by an imaginary 90 degree arc of an imaginary circle, the center of which is positioned on the hub and the perimeter of which intersects each free end.

The configuration of the present invention is designed to orient one pair of legs along an axis running from the apex of the nose to the back of the nose and a second pair of legs along a perpendicular medial axis. The first leg and the third leg are positioned opposite each other around the hub, forming the first pair of legs which is oriented into the nostril beginning at the apex of the nose. The second leg and the fourth leg are similarly positioned opposite each other around the hub, forming the second pair of legs which is oriented along the medial axis. The first leg and second leg are coplanar to their respectively paired third leg and fourth leg. Conversely, the first pair of legs is situated on a plane which is perpendicular to a plane upon which the second pair of legs is situated. The geometric shape of the legs themselves can vary with different

embodiments, examples of which are provided in FIG. 1 - FIG. 4 and FIG. 5 - FIG. 8. While FIG. 1 - FIG. 4 depict a regular embodiment with a simple-cross based pattern of legs (seen as such when viewed along the axis of the hub), FIG. 5 - FIG. 8 and FIG. 41 - FIG. 43 show how a spiral pattern of legs can be used instead. It is noted that in both embodiments the free ends of the legs are still positioned in a circular pattern with equal arcs separating each free end; this essentially maintains the orientations of each pair of legs as described with the preferred embodiment.

The spiral embodiment comprises a hole traversing through the central of the hub, as clearly illustrated in FIG. 8. This spiral embodiment has several advantages and disadvantages compared to the cross based pattern. The primary advantages of the spiral embodiment are that the spiral embodiment is easier to place and that the central hole allows for greater airflow. Flowever, the spiral embodiment is also bulkier and takes up more room than an embodiment utilizing the cross based pattern.

The free end of the first leg, which is positioned adjacent to the nostril opening when in use, comprises a tab. This tab, an elongated section of the foot, is perpendicular to the arc of the corresponding foot and oriented along the same apex-rear axis as the first pair of legs. This tab provides an easily accessed handle that allows a user to pull the present invention out of the nostril for removal. When the present invention is properly inserted into a nostril, the tab is similarly positioned within the nostril and out of sight of other persons.

In another embodiment of the present invention, the foot of the second leg, the third leg, and the fourth leg is molded at an angle. As a result, each foot comprises a lateral face which presses against the nasal walls (rather than the nasal floor as with the preferred embodiment). The tab of the first leg replaces the foot, being configured as a round ball tip. This alternative embodiment provides an alternative configuration that improves ergonomics and usability while still being able to provide the same functions and benefits of the first described embodiment. Due to these improvements, the alternative

embodiment is considered more suitable for mass production and retail.

Illustrations of this alternative embodiment are provided in FIG. 18 - FIG. 27.

In reference to FIG. 28-34, in another embodiment of the present invention, the profile of the present invention is anatomically influenced, and has three legs. They merge on the medial side of the nostril and form the largest contact area at the septal cartilage, which is relatively planar. One leg extends in the anterior direction, following the structure of the major alar cartilage. A second leg extends in the posterior direction and follows the curvature of the alar fibrofatty tissue structure. A third leg extends superior and arcs around to an inferior orientation, terminating near the posterior portion of the major alar cartilage.

The three legs serve to dilate the nasal cavity by acting on these structures. The flexibility of the device within and between each leg is primarily in the

medial/lateral direction, and secondarily in the anterior/posterior direction. In reference to FIG. 38-40, a fourth leg may also be included for additional locational stability.

The nasal apparatus as heretofore described is provided for a single nostril.

Preferably, the present invention is distributed in pairs, with an insert provided for each nostril. These pairs can be completely independent from each other such that they may easily be inserted or removed individually. Alternatively, a left nostril insert and a right nostril insert can be connected by a bridge which is connected to each nostril at the tab of the first leg. The bridge is a thin strip of material which rests against the columella of the nose; this positioning minimizes exposure of the bridge and places it such that it is mostly obscured and unassuming without directed observation. The intention is for the bridge to be essentially hidden such that it may be worn throughout the day without attracted undesired attention to a user. The visibility of the flexible bridge can be further reduced or eliminated in various ways. One non-limiting example is using a translucent or transparent material for the bridge construction. Other ways of hiding or obscuring the bridge, when included, can be utilized in other embodiments. To provide more flexibility to a user of the present invention, the bridge can be removably attached to each insert; this allows a user the choice of using the bridge for better structure or removing the bridge for better aesthetics or comfort. A user can even alter between using the bridge and not as their personal preferences or situational circumstances change. Depictions of the bridge are provided in FIG. 12, FIG. 17, and FIG. 35-36. In addition to the insert, the present invention may further comprise a separate attachable filter piece. The filter can be readily incorporated into the design via insert- molding, adhesive, or welding (thermal or ultrasonic). If adapted for use with a filter, the insert further comprises a rim that intersects the free end of each leg and is positioned around the center of the insert. The rim is preferably elliptical in shape to match the three-dimensional shape of the insert. This rim acts as a rim-mounting surface, preferably made of a silicone material to help retain an attached filter. Expanding upon the improved respiratory benefits, the

attachable filter is provided to mitigate allergens, dust particles, and other foreign bodies which might agitate or disrupt a person's nasal airways and breathing. The filter is shaped to fit over the insert, sharing the same general dome shape. The apex of the filter is positioned atop the center of the hub while the perimeter of the filter is positioned around the plurality of legs, adjacent to each free end of the legs.

Preferably, the perimeter of the filter comprises an adhesive coating to help secure the filter to the rim of the insert. Several views of the filter are provided in FIG. 13 - FIG. 17 and FIG. 37. The filter is attached to the insert through molding, in which an injection mold of the insert body is created around the insert. The insert body is permeated in several sections to allow for a secure attachment of the filter via adhesive insert molding. The attachment process can utilize a variety of methods, such as ultrasonic welding or hot joining, to complete the attachment of the filter to the insert.

To use the present invention, a user places a nasal insert in each nostril such that the first leg and associated tab are positioned adjacent to the nostril opening, the hub of the insert is positioned adjacent to the roof of the nostril, and the feet of the insert are positioned on the floor of the nostril. Once placed inside the nostril, the insert presses against the interior nostril surfaces such that the airways is expanded. To conform the insert to the nostril, a user can press on the exterior of their nose, causing the insert to take a shape matching the nostril interior. The applied force acting upon the insert (via the nostril wall) causes the insert to flatten and compress, enabled by its elastic and flexible construction. This allows the insert to better adapt to the interior of the nose while still increasing expanding the airway. Furthermore, in an embodiment which includes the filter, the combination of the filter and insert create a seal with respect to the nasal cavity, which prevents the flow of air from

circumventing the filter. The elastic and flexible construction of the insert are especially beneficial as they allow for a better range of fits with a single model size. There are a wide variety of individual characteristics which mean that what one person considers a good or comfortable fit may be poorly suited to another. Such differences are not limited across people, as a person's features are not perfectly symmetrical and their individual left and right nostrils can vary in size. Correct sizing is important with regards to nostrils, as devices which are too big are very uncomfortable while devices which are too small are not secure and less effective. The present invention overcomes these limitations, as the insert compresses and flexes to conform to a user's individual nostril. As a result, the present invention is adaptable to individual variations in nostril size and shape, providing a "one size fits all" solution. The compression of the present invention is depicted from several views in FIG. 9 - FIG. 11. The compressive forces applied to the insert by the nose and the plurality of legs help keep the inserts inside the nostril during regular everyday activities. The present invention is, minus the bridge when used, internally secured and not visible in normal situations. When a user wishes to remove the inserts and filters, such as for removal or replacement, they can simply apply pressure to the tip of the nose. Pressure should be applied in an upwards direction and in a direction opposite of the nostril the insert is being removed from. Thus, to remove an insert from the left nostril pressure is applied upwards and the tip of the nose is moved to the right, while to remove an insert from the right nostril the tip of the nose is instead moved to the left. This results in further

compression of the insert, which assumes a flatter shape. As the insert flattens, the tab which is normally positioned adjacent to the nostril opening is moved out of the nostril, providing an easily gripped handle. This exposed tab makes it simple for a user to grasp and remove the insert.

The filter and the inserts are preferably made in dark colors which do not contrast the interior of the nose and thus are effectively invisible to outside viewpoints. It is noted that when the present invention both utilizes a bridge and is made from a single mold, the bride and the inserts must be made from the same material; in this scenario the bridge and inserts are made of a transparent or translucent material to better hide the bridge. This is comparison to a bridgeless embodiment in which the inserts are made in a dark color. The filter itself can vary in several aspects, the most notable of which is the fineness of the filtering medium. In a preferred embodiment the filter prevents passage of particles that large than 0.1 microns and smaller than 100 microns in size. This range has been selected as filters which are finer than a tenth of a micron may inhibit airflow and breathing, while a filter that allows passage to particles larger than one hundred microns may prove ineffective against a number of potential allergens and other irritating foreign bodies. Ideally, the filter prevents passage of harmful or irritating particles including but not limited to bacteria, viruses, pathogens, allergens, dust, pollen, pollutants, toxins, carcinogens, and airborne particles capable of causing disease.

The filter may consist of a porous membrane, porous foam, or combination of the two. The membrane filter can be readily incorporated into the design via insert- molding, adhesive, or welding (thermal or ultrasonic). The foam filter may be incorporated with adhesive, or by incorporation of internal tabs to retain it within the structure of the nasal apparatus of the present invention.

Referring now to Figures 44 to 56, further advantageous embodiments of the apparatus of the present invention will be described in detail.

Figures 44 to 47 shows an alternative embodiment nasal apparatus 100 comprising a left and a right nostril insert 102 connected by a bridge 104.

Each nostril insert 102 comprises a plurality of arched legs, with the plurality of arched legs intersecting each other at their respective ends. The plurality of arched legs forms an elliptical dome-shaped dilator structure. The structure has a continuous perimeter around its periphery defined by two intersecting legs of the plurality of arched legs. The perimeter of the structure is preferably elliptical in shape to match the three-dimensional shape of the insert. The length of the each of the plurality of arched legs and the nature of the structure allow the device to conform to the individual user’s nostril.

The left nostril insert and the right nostril insert can be connected by a bridge 104. The bridge is a thin strip of material which rests against the columella of the nose.

Each nostril insert comprises a skirt 106 around the periphery of the insert 100. The skirt 106 is a continuation of the material comprising the dilator structure and has a relatively thin profile intended to encapsulate the fibers of a porous filter 200 around the perimeter of the device preventing irritation of the nostril from loose, frayed fibers of the filter membrane 200. The skirt 106 is integrally formed with the elliptical dome-shaped dilator structure as a unitary piece of a resilient material, preferably a plastics material. The skirt 100 can be injection molded, machined or prototyped using a 3D printer.

Figure 45 shows extended skirt section on lower portion that encapsulates the filter membrane 200. The extended skirt section provides a smooth compliant surface against the nostril, when in use. The extended skirt section directs the filter membrane 200 in a downward direction to minimize contact pressure of the edge of the device against the nasal area when in use. A small notch 108 provided where the skirt meets the elliptical dome-shaped dilator structure allows for a more comfortable, contoured and controlled bending of the skirt 108 when the device is installed within the nostril, whereas a sharp transition would result in a sharp fold and uncomfortable edge. A recessed notch 110 behind the skirt 106 allows additional deflection and reduces local stiffness.

The filter membrane 200 can be readily incorporated into the nostril insert 102 via insert- molding, adhesive, or welding (thermal or ultrasonic). The filter membrane 200 may also include additives for additional filtration capability such as activated carbon, anti-microbial coatings, essential oils, etc. Ideally, the filter prevents passage of harmful or irritating particles including but not limited to bacteria, viruses, pathogens, allergens, dust, pollen, pollutants, toxins, carcinogens, and airborne particles capable of causing disease.

Each nostril insert 102 may also comprise a tab (not shown) on the inside of the insert to allow for incorporation of an additional volumetric filter. Tabs are designed to retain a volumetric filter (not shown) between the tabs and the volume defined within the legs of the dome-shaped dilator structure. Tabs may be integrally formed with the elliptical dome-shaped dilator structure as a unitary piece of a resilient material, preferably a plastics material. The volumetric filter is a filter that substantially fills the volume defined within the legs of the dome-shaped dilator structure. The volumetric filter may comprise a foam structure suitable for filtering. Alternatively, the volumetric filter may comprise a membrane filter material folded with a plurality of folds such that the folded membrane filter occupies substantially the entire of the volume of the space defined by the legs of the dome-shaped dilator structure. The volumetric filter comprises any porous, compliant material for example reticulated foam (polyurethane, polyethylene, silicone rubber, etc). The foam may also contain additives for additional filtration (e.g activated carbon, anti microbial coatings, essential oils, etc).

The volumetric filter may be combined with a membrane filter 200 such that the nostril insert 102 comprises a first filter which may be a membrane filter 200 and a second volumetric filter adjacent to the membrane filter 200.

Figures 48 to 56 shows an alternative embodiment of the nasal apparatus 100 shown in Figures 44 to 47. The nasal apparatus 400 comprises a left and a right nostril insert 402 connected by a bridge 404 as substantially described in the embodiment of Figures 44 to 47. In this embodiment, each of the plurality of arched legs comprises a free end. The plurality of arched legs does not intersect each other at their free ends. This arrangement provides for additional flexibility between the legs of the nasal apparatus 400.

The plurality of arched legs forms an elliptical dome-shaped dilator structure. In this embodiment, the structure has a discontinuous perimeter around its periphery defined by at least two legs of the plurality of arched legs. The discontinuous perimeter of the structure is preferably elliptical in shape to match the three-dimensional shape of the insert. Preferably, the discontinuous perimeter may be defined by three legs of the plurality of arched legs, wherein one of three legs defines a portion of the perimeter at its free end. In this embodiment, a skirt 406 is located around the discontinuous perimeter of the structure. The skirt 406 is a continuation of the material comprising the dilator structure and has a relatively thin profile intended to encapsulate the fibers of a porous filter 200 around the perimeter of the device. A small notch 408 and a recessed notch 410 are provided in the proximity of the skirt as described with reference to the embodiment of Figures 44 to 47. A significant advantage of the inclusion of the skirt 406 around the discontinuous perimeter is to allow compressive flexibility while maintaining the aforementioned benefits in key pressure areas of the device as described with reference to the

embodiment of Figures 44 to 47.

Each nostril insert may also comprise a tab 405 on the inside of the insert 400 to allow for incorporation of an additional volumetric filter 300 as described with reference to the embodiment of Figures 44 to 47.

In another aspect of the present invention, the apparatus of the present invention may be used for delivery of a therapy or therapeutic agent to be delivered intradermally or intramucousally. This may also be referred to herein as“drug delivery”. Referring now to Figures 57 to 71 , the aspect of the present invention relating to delivery of a therapeutic agent will now be described.

The dilator structure may be composed of in its entirety or coated with a drug absorbent material, for example a material such as polyvinyl acetate, Pebax, and various elastomers known to absorb and release small molecules

(therapeutic agents) in a repeatable manner. In the case where the controlled release material is very soft, flexible, or gelatinous, a coating process may be employed onto a structure formed from a separate material such as a

thermoplastic (e.g. Polyethylene, polypropylene, etc), or a material such as a thermoplastic elastomer or room temperature vulcanizing rubber of appropriate durometer / stiffness. The coating process may be done through over-molding in the case of a thermoplastic elastomer, or dip-coating followed by drying in the case of materials curing or solidifying in the presence of air or evaporation of solvents. For thin coatings, a spray application could also be employed. These various approaches may also be limited to the bridge section of the device in cases where aromatic release is sufficient for the intended effect for instance, in the case of aromatherapy, such as using essential oils.

In place of, or in combination with the dilator structure, the filter material may also act as a carrier of therapeutic agents in whole or in part. For example, the therapeutic agent may be included into a polymer during an electrospinning process or coated onto a substrate via an electro spraying process. Also, a non-woven filter substrate may act as a support structure for a thin film of drug loaded material. The dilator / filter structure would eliminate the need for the use of mucousal adhesives for nasal delivery applications by virtue of its ability to hold the drug loaded material against the nostril surface while it is installed.

A significant advantage of the therapeutic delivery using the nasal apparatus of the present invention is that a therapy/drug eluting nasal insert as provided by the present invention overcomes the limitations of a nasal drug delivery via spray. Such limitations are contact time, limited delivery due to evaporation, inhalation, and mucociliay clearance. Instead, the present invention provides a drug eluting dilator apparatus which has the above advantages as well as the advantage that it remains in place in the nostril(s) of a user for an amount of time which is controllable by the user.

Figures 57 and Figure 58 are views of the nasal apparatus of the present invention comprising the arms which are adapted for absorbing a drug for loading onto the apparatus, for example, the apparatus may be formed of Pebax or Ethyl Vinyl Acetate material, and the drug is released via diffusion into the nasal membranes when the nasal filter device is inserted in the nostrils in use. Figures 59 and 60 show an alternative arrangement for drug delivery in which thebulk material absorbs drug for loading, and the drug is released via diffusion, however, in this embodiment, only the bridge section of the device is loaded. This arrangement is particularly useful for delivery of aromatic compounds as it avoids having the drug in direct contact with mucous membranes. (This is useful for delivery of scented oils, etc)

Figures 63 and 64 show an alternative arrangement in which the bridge section of the device comprises drug absorbent material for loading/release. The drug absorbent material can be a wicking material (cloth, fabric, sponge, foam, etc). This is advantageous in that the drug / scented oil can be loaded directly onto wicking portion of device;

Figure 66 shows a similar embodiment to that shown in Figures 63 and 64 with the bridge section comprising drug absorbent material for loading/release (The embodiment shown in Figure 65 is the same arrangement as that shown in Figures 63 and 64, but with filter included);

Figure 68 shows an exploded view of the arms of the device dip-coated with drug and releasable when in contact with the mucous membranes; Figure 69 shows the device coated with drug, releaseable when in contact with mucous membranes (filter not included); and

Figure 70 shows the device coated with drug, releaseable when in contact with mucous membranes (filter included).

Thus, in this aspect of the present invention, an advantageous method is provided for delivering a therapy intradermally or intramucousally including a therapy such as a medicament including drug delivery, delivery of essential oils or any desirable therapy that can be delivered intradermally or intramucousally through the nasal mucous membranes.

Although the invention has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the invention.

Claims

1 . A nasal apparatus comprising:

a nasal insert, the nasal insert comprises a hub, a plurality of arched, flexible legs, wherein:

a) each of the plurality of arched, flexible legs comprises a proximal end and a free end;

b) the proximal end and the free end are opposite ends of the same leg;

c) the free end of each of the plurality of arched, flexible legs comprises a foot, each foot providing an expanded lateral face;

d) the proximal end of each of the plurality of arched legs is adjacently connected to the hub; wherein the free ends are disjointed from the hub;

e) the plurality of arched, flexible legs is positioned around the hub;

f) the expanded lateral face of each foot is designed to apply pressure against an inner nasal surface of a nostril, when the nasal insert is positioned in the nostril;- g) the nasal insert being flexible, and applies pressure to the inner nasal surface of the nostril when the nasal insert is positioned within the nostril, thereby holding the insert within the nostril(s); and wherein

h) the foot of each of the plurality of arched, flexible legs is arc-shaped and extends laterally from the leg, and

i) the plurality of arched legs allows flexibility in key anatomic locations, the profile cross section of the leg being configured to allow bending along its thin dimension, while maintaining a relatively large area of contact in its long dimension, so as to conform to an individual user’s nostril(s).

2. The nasal apparatus of claim 1 , wherein the apparatus comprises a first leg, a second leg, and a third leg, which 3 legs merge on the medial side of the nostril, forming a large surface area for contacting the septal cartilage, when the apparatus is inserted into the nostril(s).

3. The nasal apparatus of claim 1 , wherein the plurality of arched legs includes a first, second, and a third leg, wherein, when the apparatus is inserted into the nostril(s):

a) the first leg is configured to extend in an anterior direction, following the structure of the majar alar cartilage of the nostril; - b) the second leg is configured to extend in a posterior direction, following the curvature of an alar fibrofatty tissue structure; and

c) the third leg is configured to extend in a superior direction, and then to arc around to an inferior orientation, terminating near a posterior portion of the majar alar cartilage.

4. The nasal apparatus of claim 1 , comprising a pair of nasal apparatus conjoined by a bridge, where the bridge provides a mechanism to protect against inserting the nasal apparatus too far into the nostril(s), while also serving as a mechanism for removing the nasal apparatus from the nostril(s).

5. The conjoined nasal apparatus of claim 4, wherein the bridge is removably attached to each nasal apparatus of the pair.

6. The nasal apparatus of claim 1 comprising:

a) a filter;

b) the filter being attached to the nasal apparatus;

c) wherein the perimeter of the filter is positioned around the plurality of arched legs, adjacent to the free end of each of the plurality of arched legs.

7. The nasal-apparatus of claim 6, wherein the filter is attached to the nasal apparatus through a molding process, where an injection mold of the insert body is created around the nasal apparatus.

8. The nasal apparatus of claim 1 , wherein the foot is molded at an angle; and optionally, wherein the edge of each foot is smooth and rounded.

9. The nasal apparatus of claim 6 wherein:

a) the nasal apparatus comprises a rim;

b) the filter comprises an adhesive coating;

c) the rim intersects the free end of each of the plurality of arched legs; and

d) the filter is secured to the rim via an adhesive coating.

10. The nasal apparatus of claim 4, wherein the bridge connecting the conjoined pair of nasal apparatus is formed of a translucent or transparent material.

11. The nasal apparatus of claim 6, wherein the filter is incorporated into the nasal apparatus via insert-molding, adhesive, or thermal or ultrasonic welding.

12. The nasal apparatus of claim 9, wherein the rim is elliptical in shape.

13. The nasal apparatus of claim 9, wherein the perimeter of the filter comprises an adhesive to secure the filter to the rim.

14. The nasal apparatus of claim 9, wherein the rim comprises a silicone material to aid retention of an attached filter.

15. The nasal apparatus of claim 9, wherein the perimeter of the filter is positioned around the plurality of legs, and adjacent to each of the free ends of the legs.

16. The nasal apparatus of claim 6 wherein the apparatus includes a skirt for holding the filter material on the nasal apparatus.

17. The nasal apparatus of claim 6 wherein the filter comprises a filter which occupies substantially the entire space defined within the arms of the apparatus, the filter comprising a volumetric filter.

18. The nasal apparatus of claim 17 wherein the apparatus includes at least one tab for holding the volumetric filter in the apparatus.

19. The nasal apparatus of claim 6 wherein the filter comprises a first filter and a second filter.

20. The nasal apparatus of any one of the preceding claims configured for loading and deliver of a medicament.

21 . The nasal apparatus of any preceding claim wherein the apparatus is formed from any one or more of the following group: a soft thermoplastic material, or a material having a low modulus of elasticity, such as low or medium density polyethylene; or formed of a thermoplastic elastomer such as pebax, polyvinyl alcohol, or a thermoplastic urethane.

22. The nasal apparatus of claim 19 wherein the first filter comprises a membrane filter.

23. The nasal apparatus of claim 22 wherein the membrane filter is formed of a nonwoven thermoplastic material such as polyethylene, nylon, or polypropylene.

24. The nasal apparatus of claim 22 or claim 23 wherein the membrane filter also comprises electrospun nanofibers from materials such as polyacrylonitrile, polyvinylpyrrolidone, polyurethane, polyimide, polyethylene, etc. or any combination of meltblown, woven, and electrospun fibers.

25. The nasal apparatus of claim 6 or any one of claims 19 to 24 wherein the second filter comprises a foam filter.

26. The nasal apparatus of claim 25 wherein the foam filter comprises a compliant open cell foam such as polyurethane or silicone.

27. The nasal apparatus of any one of claims 6 or claims 22 to 26 wherein the filter also comprises an additive such as activated carbon, or an anti microbial additive or an anti-microbial treatment.

28. A method of delivering a therapy intradermally or intramucousally comprising the following steps:

Loading a therapy onto at least a portion of the apparatus claimed in claim 1.