NL2026058B1

NL2026058B1 - Nose insert

Info

Publication number: NL2026058B1
Application number: NL2026058A
Authority: NL
Inventors: Wilhelmus Maria Boesten Michael; Peter Marie Vrinzen Alexander
Original assignee: Water & Minerals Advice B V
Priority date: 2020-07-15
Filing date: 2020-07-15
Publication date: 2022-03-18

Abstract

The invention relates to a device (2) configured to be at least partially inserted in the nose at the position of at least one nostril, wherein the device (2) comprises at least one functional part (11, 12) that is configured to reside at the position of the mucous wetted area of the at least one nostril in a functional position of the device (2) in the nose. The device (2) comprises, at least at the position of the at least one functional part (11, 12), a therapeutic or health-enhancing agent. The therapeutic or health-enhancing agent may be an antimicrobial agent such as an antimicrobial metal or metal alloy material, in which case the functionality of the device (2) involves overall activation of the innate immune system and reduction of infectious bacteria and viruses in the nose, throat and mouth cavities.

Description

WATER20003NL/PO -1-

NOSE INSERT

FIELD OF THE INVENTION The invention relates to a device that is configured to be at least partially inserted in the nose at the position of at least one nostril and to be put to a functional position in the nose.

BACKGROUND OF THE INVENTION The invention is aimed at improving human health, for example, by reducing the infection effectivity of bacteria and viruses present in the mucous in the respiratory system or by supplying a medicine. This is done by providing a device that is configured to be at least partially inserted in the nose at the position of at least one nostril and to be put to a functional position in the nose. The device may be designed to cause killing or inhibiting of pathogens in the respiratory system including the nose area, and also in associated areas such as the upper part of the digestive system including the mouth. When a person applies the device in that case, this is not only beneficial to that person's health - reducing the infection risk -, but also to the health of the people in that person's environment, because the infectiveness of any droplets released by that person through breathing and/or yawning, coughing and/or sneezing is reduced. It is also possible that the device is designed to slowly release medicine to the mucous in the nose.

SUMMARY OF THE INVENTION Aspects of the invention are set out in the accompanying independent and dependent claims.

Features of the dependent claims may be combined with features of the independent claim as appropriate and not merely as explicitly set out in the claims.

In view of the foregoing, the invention provides a device configured to be at least partially inserted in the nose at the position of at least one nostril and to be put to a functional position in the nose, wherein the device comprises at least one functional part that is configured to reside at the position of the mucous wetted area of the at least one nostril in the functional position of the device in the nose, and wherein the device comprises, at least at the position of the at least one functional part, a therapeutic or health-enhancing agent, intrinsic and/or to be formed in a reaction.

The therapeutic or health-enhancing agent may be an antimicrobial agent such as an antibacterial and/or antiviral material, particularly an antibacterial and/or antiviral metal or metal

WATER20003NL/PO -2- alloy material.

In the following, the invention is explained in the context of the option of the therapeutic or health-enhancing agent being an antimicrobial agent.

The device according to the invention is designed in such a way that when the device is in the functional position in the nose, the mucous present in the nose is contacted by the at least one functional part of the device. lons of the antimicrobial agent are slowly released at the position of the at least one functional part, by reaction and/or through dissolving in the mucous, and the antimicrobial ions are directly absorbed by, and distributed throughout, the mucous.

Practical and effective use of the device involves having the device in the functional position in the nose for a certain period of time.

Pathogens such as bacteria and viruses present in the mucous are killed or inhibited by the dissolved antimicrobial ions and/or the antimicrobial ions formed by reaction.

Further, the local immune system is enhanced while applying the device and also after the device has been removed from the nose again.

In the following, for the sake of clarity, the device will be referred to as nose insert.

It follows from the foregoing explanation of the invention that the nose insert is designed to act as a local immune system enhancement.

The improvement of the elimination and removal of pathogens that is obtained is based on several mechanisms.

A notable function of the nose insert is enhancement of the innate immune system performance in the respirational track with respect to identification and elimination of pathogens.

The antimicrobial ions released by the contact of the mucous with the nose insert increases the concentration of the antimicrobial ions in the mucous.

This has a number of effects, including 1) an increased uptake of the antimicrobial ions by bacteria, which thereby will become more easily recognized by the phagocytes in the mucous, 2) a rise of the concentration of the antimicrobial ions in the bacteria to a toxic level, as a result of which the bacteria are killed and release of their cell content takes place, which further contributes to activating the innate immune system, and 3) marking, damaging and destruction of bacteria and viruses in direct contact with the mucous.

The nose insert influences the mucous viscosity and/or mucous production.

The excess and/or less viscous mucous improves the removal of bacteria and viruses through the stomach.

In view of the foregoing, it is to be noted that the nose insert is intended for use as a temporary support system of a person's immune system, during and after situations of elevated risk of inhalation of pathogens and/or as a temporary removal system of bacteria and virus load present in part of the respiratory system.

Practical examples of the antimicrobial and/or antiviral metal or metal alloy material include copper, zinc and silver.

In an advantageous embodiment of the nose insert, the antimicrobial and/or antiviral metal or metal alloy material is one of a partially oxidized metal or metal alloy material and a metal or metal

WATER20003NL/PO -3- alloy material that oxidizes and dissolves under the influence of contact to mucous. This embodiment is developed on the basis of an insight that oxidized metal or metal alloy has a higher metal ion solubility than pure metal or metal alloy.

The invention also covers the option of the nose insert being intended to be used for realizing a slow release of medicine to the mucous in the nasal area. In such a case, it will mostly be so that the medicine is provided as a coating of a substrate. The medicine may be provided in a form suitable for direct transfer from the nose insert to the mucous and/or in a form that enables the necessary transfer on the basis of a reaction.

It may be practical if the nose insert comprises, at least at the position of the at least one functional part, a substrate supporting a coating, wherein the therapeutic or health-enhancing agent is included in the coating. Alternatively, it is possible that the nose insert only comprises a substrate including the therapeutic or health-enhancing agent. The invention covers the option of having more than one type of therapeutic or health-enhancing agent in the nose insert.

The at least one functional part may be shaped in any suitable way. In any case, it is beneficial if the at least one functional part is large enough to ensure the health benefits as envisaged yet small enough to not hinder the air flow through the nose. For example, the at least one functional part may be shaped as an enlarged end part of the nose insert. In general, the at least one functional part may be of a shape involving a relatively large surface, and the design of the at least one functional part may be based on plate-shaped, cylinder-shaped, circular-shaped, spherical-shaped or wire-shaped structures.

According to a practical option existing in the context of the invention, the nose insert may be configured to be at least partially inserted in the nose at the position of both nostrils simultaneously and may comprise two functional parts in that case, one functional part for each nostril. A first advantage is that a larger area of the nose can be subjected to the action of the nose insert. A second advantage is that the nose insert can be supported in a reliable manner, namely by means of a clamping action from two sides on the nasal septum, in which case it is beneficial if the nose insert comprises two leg-shaped parts which can be moved towards and away from each other, for example.

The nose insert may be of any suitable design, and may be generally U-shaped, for example, in which case the nose insert comprises the above-mentioned two leg-shaped parts. It may be advantageous if the design is relatively simple and only involves a minimum of components. In this respect, it is noted that an embodiment of the nose insert is feasible in which the nose insert is shaped as a single integral entirety. For example, the nose insert may comprise a single bent wire, wherein optionally the wire is wound to a spiral at the position of the at least one functional part.

WATER20003NL/PO -4- According to another practical option, the nose insert may comprise two discs connected through a wire body.

In general, it is very practical if the nose insert is configured to releasably connect to the nose in a functional position of the nose insert in the nose. In that case, hands-free use of the nose insert is allowed. As suggested earlier, it may be handy if the nose insert is configured to be clamped on the nasal septum in a functional position of the nose insert in the nose, which does not alter the fact that other ways of enabling the nose insert to support itself in/on the nose are covered by the invention. It is possible that the at least one functional part is configured to abut against the nasal septum in the functional position of the nose insert in the nose. In that way, the functional part can have a combined functionality of contacting the mucous in the nose and supporting the nose insert in/on the nose. The use of an external support system for supporting the nose insert in/on the nose is another possibility that is included in the invention.

BRIEF DESCRIPTION OF THE DRAWINGS Further features and advantages of the invention will become apparent from the description of the invention by way of exemplary and non-limiting embodiments of a nose insert.

The person skilled in the art will appreciate that the described embodiments of the nose insert according to the invention are exemplary in nature only and not to be construed as limiting the scope of protection in any way. The person skilled in the art will realize that alternatives and equivalent embodiments of the nose insert can be conceived and reduced to practice without departing from the scope of protection of the invention.

Reference will be made to the figures on the accompanying drawing sheets. The figures are schematic in nature and therefore not necessarily drawn to scale. Further, equal reference numerals denote equal or similar parts. On the attached drawing sheets, figures 1 and 2 diagrammatically show different views of a nose insert according to a first embodiment of the invention, wherein figure 1 shows the nose insert in a non-operational position and figure 2 shows the nose insert in an operational clamping position; and figures 3 and 4 diagrammatically show different views of a nose insert according to a second embodiment of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS Figures 1 and 2 show different views of a nose insert 1 according to a first embodiment of the invention. The nose insert 1 comprises two functional parts 11, 12 and a connecting part 13 extending between the functional parts 11, 12 and connecting the functional parts 11, 12. In the

WATER20003NL/PO -5- shown example, the functional parts 11, 12 comprise discs and the connecting part 13 comprises a wire body. The connecting part 13 is flexible to such an extent that it is possible to bend the connecting part 13 to different shapes, wherein the connecting part 13 will maintain the latest shape until another one is set.

Inserting the nose insert 1 in the nose is done by positioning each of the functional parts 11, 12 at a nostril and moving them upwards in the nose. The nose insert 1 is in a functional position in the nose when the functional parts 11, 12 are at the level of the mucous wetted area of the respective nostrils, in which position the nose insert 1 is generally in the shape of a U, as shown in figure 2, and the connecting part 13 extends underneath the nasal septum. The nose insert 1 can be fixed in/on the nose by pressing the functional parts 11, 12 towards each other once the nose insert 1 is in the functional position in the nose, so that the nose insert 1 is clamped on the nasal septum. The functional parts 11, 12 may be designed to enhance the clamping effect and may each comprise one or more elevated portions 14, for example, as shown.

Figures 3 and 4 show different views of a nose insert 2 according to a second embodiment of the invention. The nose insert 2 comprises two functional parts 11, 12 and a connecting part 13 extending between the functional parts 11, 12 and connecting the functional parts 11, 12. In the shown example, the nose insert 2 comprises a single bent wire and is generally U-shaped, the wire is wound to a spiral at the position of the respective functional parts 11, 12. On the basis of the bendable properties of the wire, it is possible to move the functional parts 11, 12 apart to some extent for the purpose of putting the nose insert 2 in place in/on the nose or removing the nose insert 2 from the nose, and to clamp the nose insert 2 on the nasal septum by pressing the functional parts 11, 12 towards each other with the nasal septum between them in the functional position of the nose insert 2 in the nose.

Many alternative embodiments of the nose insert are feasible in the context of the invention, wherein it is noted that the nose insert may be designed for multiple use or for limited or single use only. In the latter case, the nose insert may be provided as a foil-like body, for example, comprising a bendable strip having enlarged end portions.

In the following, advantageous features of the nose insert according to the invention are addressed in relation to the option that the nose insert functions to kill or inhibit pathogens and to stimulate the immune system. This information is applicable to the above-described nose insert 1 according to the first embodiment of the invention and the nose insert 2 according to the second embodiment of the invention, and also to numerous possible alternative embodiments. The present focus on the option as mentioned does not alter the fact that other options are covered by the invention as well, such as an option of the nose insert functioning to slowly release medicine.

WATER20003NL/PO -6- In the first place, it is noted that the nose insert is easy to place and to remove after use. It is recommended to leave the nose insert in for a certain period of time so as to have the full benefit of the nose insert. Further, in case the nose insert is intended for multiple use, the nose insert can easily be cleaned and regenerated for reuse. Still further, the nose insert can be used in addition to conventional personal protection devices such as a face mask.

In the second place, it is noted that an important function of the nose insert is to activate the immune system of the nose, throat and mouth mucous and to thereby reduce the infection risk from inhalation and air transmission. To that end, at least the functional parts of the nose inserts are plated with an antimicrobial material such as a metal or a metal alloy or are entirely made of such a material. It is known that copper, zinc, silver and other metals or metal alloys have antibacterial and antiviral properties when used by humans.

The nose insert according to the invention activates the immune system in the mucous of the respiratory system, i.e. in the nose and throat, and also partially in the mouth, and thereby decreases the infection risk for bacteria and viruses. The reduction of the infection risk is based on several different mechanisms of interaction of the nose insert with the nose mucous and of distribution of the mucous. One of those mechanisms resides in the fact that direct contact with the used antimicrobial agent is lethal to bacteria and viruses. Another of those mechanisms resides in the fact that the mucous that is in contact with the antimicrobial ions distributed in the nose, throat and mouth cavities gets activated to attack the bacteria and viruses present in those areas. As an advantageous result, the mucous - is lower in bacteria and virus activity, - recognizes the bacteria and viruses faster, « the antimicrobial ions taken up by the bacteria and viruses make them better recognizable for the innate immune system, + this is applicable to the immune systems of both the carrier and the receiver of this mucous, - is standby for actions by the immune system, « the amino acids released by the destroyed bacteria’s DNA and viruses’ RNA, which are foreign to the body, activate the innate immune system in the mucous, and - has a lower active bacteria and virus load present, + the antimicrobial ions in the mucous destroy part of the bacteria and viruses, due to excessive uptake of the antimicrobial agent, « the immune system destroys part of the bacteria and viruses, + this is applicable to the immune systems of both the carrier and the receiver.

WATER20003NL/PO -7- The infection potential of transmission by airflow is directly linked to the concentration and activities of bacteria and viruses present in the mucous of the respiratory system. Thus, the nose insert reduces the overall infection potential of inhaled and exhaled air, activates the immune system to be prepared to attack bacteria and viruses of inhaled infective air, and also activates the mucous in exhaled air to attack bacteria and viruses present.

A number of notable aspects of the nose insert are listed in the following.

1. The nose insert is configured to directly contact to the mucous in the nose.

2. The design of the nose insert is suitable for letting contact to the mucous take place for a certain (longer) period of time.

3. Use of the nose insert brings about slow release of antimicrobial ions to the mucous. In respect of the option of relying on a use of an antimicrobial metal or metal alloy, it is noted that oxidized metal has a higher metal ion solubility than pure metal, and that the amount of metal ions should be high enough to damage and kill bacteria and viruses (yet low enough to avoid structural damage to the epithelia/body).

4. As a result of having the nose insert in the functional position in the nose, mucous production is stimulated and mucous flow out of the nose cavity area is increased. Further, it may be so that the viscosity of the mucous is reduced.

5. Accessibility of innate immune system cells in mucous to the bacteria and viruses is increased, due to breaking up of bacteria colonies.

6. The bacteria grow and flow are influenced on the basis of the antimicrobial ions gradient. First, the bacteria need the antimicrobial ions to grow, and thereby a colony changes its shape from round to flat, so that the surface of the colony is increased and the colony is more accessible to the immune B-cells. Second, if the uptake of antimicrobial ions is too high, the bacteria increase the distance along the concentration gradient to avoid death. B-cells have better access and better recognition based on the high uptake of antimicrobial agent by the bacteria. Third, too high uptake of antimicrobial agent kills bacteria, without intervention of the innate immune system.

7. The nose insert contributes to diluting the mucous with killed and damaged bacteria and viruses, which is useful in reducing transmission risk.

8. The nose insert acts to reduce the number of bacteria and viruses capable of infecting the mucous and epithelia in the breathing system.

9. The nose insert acts to remove stationary bacteria colonies in the nose area.

Concluding, the functionality of the nose insert involves overall activation of the innate immune system and reduction of infectious bacteria and viruses in the nose, throat and mouth cavities.

Another overview of summarizing statements and further details is provided below.

WATER20003NL/PO -8- - The functioning of the nose insert relies on direct contact with the mucous. « During use of the nose insert, active ingredient is released into the mucous.

The bacteria and viruses take up the antimicrobial ions from the nose insert as a result of which the bacteria and viruses get killed and also the bacteria and viruses are made detectable as foreign material to the innate immune cells in the mucous. + On the basis of the direct contact with the mucous, the following reactions are obtained: dissolving of the active ingredient in the mucous, increase of the solubility and formation of optimal soluble anti-bacterial and/or anti-viral material.

In respect of the increase of the solubility, it is noted that this follows from a reaction with water, and/or a reaction with oxygen, and/or a reaction with carbon dioxide, and/or a reaction with a component present in the mucous. - When the nose insert is in the functional position in the nose, the nose insert directly contacts inhaled/exhaled air. * The bacteria and viruses take up the antimicrobial ions from the nose insert as a result of which the bacteria and viruses get killed and also the bacteria and viruses are made detectable as foreign material to the innate immune cells in the mucous. - Various options in respect of the way in which the nose insert can be supported in/on the nose exist. « Functional options include supporting the nose insert in a nostril and supporting the nose insert in the nose. « In respect of the first functional option of supporting the nose insert in a nostril, this may be against the nasal septum, at one side or at both sides. « In respect of the second functional option of supporting the nose insert in the nose, this may particularly involve supporting the nose insert by nose internals.

This may be against a nasal wall, at one side or two sides. « Artistic/aesthetic considerations can be made, wherein it is especially to be assessed which part(s) of the nose insert is/are visible at the outside when the nose insert is in the functional position in the nose. - The nose insert comprises anti-bacterial and/or anti-viral material, optionally provided in a coating. « The nose insert can be made of copper, zinc, silver or another suitable material for releasing metal ions. + It is advantageous if the nose insert comprises a substrate and a coating applied to the substrate, because the release rate of the antimicrobial ions may be enhanced by having a

WATER20003NL/PO -9- coating. Such a coating may comprise small particles of copper, zinc, silver or another suitable material and may also comprise organic and inorganic anti-bacterial and/or anti-viral materials. +» Soluble anti-bacterial and/or anti-viral material is intrinsically present or created due to reaction with oxygen from air, carbon dioxide from air, and/or water from air and/or mucous. * The specifics of the nose insert can be chosen such that slow release of the antimicrobial ions into the mucous is realized and that the concentration of the antimicrobial ions is toxic to bacteria and viruses and at the same time nontoxic to humans, so that there will be no harmful effects on the respiratory system and the digestive system.

It will be clear to a person skilled in the art that the scope of the invention is not limited to the examples discussed in the foregoing but that several amendments and modifications thereof are possible without deviating from the scope of the invention as defined by the attached claims. In particular, combinations of specific features of various aspects of the invention may be made. An aspect of the invention may be further advantageously enhanced by adding a feature that was described in relation to another aspect of the invention. While the invention has been illustrated and described in detail in the figures and the description, such illustration and description are to be considered illustrative or exemplary only, and not restrictive. The invention is not limited to the disclosed embodiments. Variations to the disclosed embodiments can be understood and effected by a person skilled in the art in practicing the claimed invention, from a study of the figures, the description and the attached claims. In the claims, the word “comprising” does not exclude other steps or elements, and the indefinite article “a” or “an” does not exclude a plurality. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference numerals in the claims should not be construed as limiting the scope of the invention.

Claims

WATER20003NLPO 10 CONCLUSIONS

A device (1, 2) configured to be at least partially inserted into the nose at at least one nostril and to be placed in a functional position in the nose, wherein the device (1, 2) is comprises at least one functional portion (11, 12) configured to be present in the functional position of the device (1, 2) in the nose at the region of the at least one nostril containing mucus, and wherein the device (1, 2) comprises a medicinal or health-promoting substance at least at the location of the at least one functional part (11, 12).

The device (1, 2) according to claim 1, wherein the medicinal or health promoting substance is an antimicrobial substance.

The device (1, 2) of claim 2, wherein the antimicrobial substance is an antimicrobial metal or metal alloy material.

The device (1, 2) of claim 3, wherein the antimicrobial metal or metal alloy material is one of a partially oxidized metal or metal alloy material and a metal or metal alloy material that oxidizes and dissolves upon contact with slime.

A device (1, 2) according to any one of claims 1-4, comprising, at least at the location of the at least one functional part (11, 12), a substrate with a coating thereon, wherein the medicinal or health-promoting substance is contained in the coating is located.

A device (1, 2) according to any one of claims 1-4, comprising, at least at the location of the at least one functional part (11, 12), a substrate containing the medicinal or health-promoting substance.

The device (1, 2) according to any one of claims 1-6, wherein the at least one functional portion (11, 12) is formed as an enlarged end portion of the device (1, 2).

WATER20003NLPO 11

The device (1, 2) according to any one of claims 1 to 7, configured to be at least partially inserted into the nose at both nostrils simultaneously, and comprising two functional parts (11, 12).

A device {1, 2) according to any one of claims 1-8, which is generally U-shaped.

A device (2) according to any one of claims 1-9, which is formed as a single integral whole.

A device (2) according to any one of claims 1-10, comprising a single bent wire.

A device (2) according to claim 11, wherein the wire is spirally wound at the location of the at least one functional part (11, 12).

A device (1) according to any one of claims 1-8, comprising two discs (11, 12) which are connected by a wire body (13).

A device (1, 2) according to any one of claims 1-13, configured to be releasably connected to the nose in a functional position of the device (1, 2) in the nose.

A device (1, 2) according to any one of claims 1-14, configured to be clipped onto the nasal septum in a functional position of the device (1, 2) in the nose.