Field of the invention

The present invention relates to a disposable nasal liquid dispenser device for administering a controlled quantity of a liquid solution to the nasal cavities and / or paranasal sinuses of a user. The device is intended to be used for the cleaning and / or disinfection of nasal cavities and paranasal sinuses and / or for the treatment of nasal and / or sinus disorders such as sinus inflammation, including nasal congestion.

Background

Sinus and nasal congestion or rhinitis, involves the blockage of one or more of the paranasal sinus passageways in the skull. The paranasal sinuses are air-filled cavities within the facial skeleton. Each paranasal sinus is contiguous with a nasal cavity and connects with it via small orifices called ostia. The blockage of the ostia may result from inflammation and swelling of nasal tissues or the presence of excess mucus. When inflammation occurs, normal drainage of mucus from within the sinuses is disrupted, and sinusitis may occur.

Described paranasal sinuses are frontalis sinuses, ethmoid sinuses, sphenoid sinuses and maxillary sinuses.

While acute nasal congestion is frequently caused by acute infections, chronic nasal congestion usually results from exposure to irritants such as tobacco smoke, food allergens, inhaled allergens, or foreign matter within the nasal cavity. So, maintenance of clear and healthy nasal cavities and paranasal sinuses of humans is part of proper medical, family and / or personal care.

Further, the respiratory system is subject to continuous risks of viral diseases and microbial infections, mainly during the winter. SARS-Cov2 infection mainly begins in the nasopharyngeal area, it is incubated there for a period of time and then it gains entrance to the rest of the respiratory tract ^{1 2} . Flypertonic saline exposure of human cells like epithelial, mucosal and immunity cells in the upper respiratory system increases their antiviral activity against many respiratory pathogens including previously known coronaviruses and SARS-Cov2. Specifically, hypertonic saline solution promotes innate immunity responses in various ways, such as inducing depolarization of the epithelial cells putting them in a low energy state, thus decreasing the ability of the virus to replicate ³ and / or it induces increased production of hypochlorite ions via myeloperoxidase dependent reaction due to increased chloride ions concentration ⁴ . This increase in antiviral innate immunity has been shown clinically in upper respiratory infection including other coronaviruses where the use of hypertonic saline has reduced both the duration of disease and the need for use of other medications ⁵ .

Traditional techniques to clean the nasal cavities and to treat nasal congestion include techniques of nasal irrigation and use of decongestant sprays which cause vasoconstriction of the nasal cavity mucosa reducing inflammation.

Decongestant sprays rapidly reduce edema mainly in the nasal cavity mucosa and make breathing through the nose easier. However, these sprays do not reach the whole mucous membrane surface of the nasal cavities and the paranasal sinuses. It is needed to reach these parts of the mucosa to treat illnesses, e.g. sinusitis, which cannot be cured by current limited local treatment.

Another way of administering liquid solutions into the nasal cavities is by allowing a solution to flow through a tightening olive, which fits to the nostril, on its upper side and can be attached to some kind of container or tube on its bottom. Although the olive fits the nostril, it is not possible to fill the nose and let the solution reach the upper and inner parts of the nose, as the solution runs back into the pharynx along the bottom of the cavities.

Researchers and medical device manufacturers, acknowledging the great benefits to humans of having a healthy respiratory system, continuously try to find ways to inject therapeutic solutions to the paranasal sinuses. Many existing devices use various techniques but only partially achieve cleaning of the nostrils from excretions and do not succeed in injecting therapeutic solution to the paranasal sinuses in a controlled way.

For example, the device described in US 2014/0121592 provide liquid in the nasal cavities, allowing for a quick cleaning or short-term treatment of the nasal cavities. However, the infected fluid returns to the container from the same spout, probably passing some infected material to the clean liquid. This short term period leads to a temporary solution.

In addition, the device of WO 2013/072856 has to be connected to a source of compressed air in order to provide the fluid in the nostril. If the user was to receive a treatment in the paranasal cavities, the use of such a device would either cause the user to choke and/or to feel highly uncomfortable, stressed, while injury could be provoked to upper respiratory system including ears via eustcahian tubes. In addition, WO 99/26684 describes a device designed for delivering a constant controlled flow of liquid or many equal doses of liquid to the nasal cavities. However, even this device, is used for rinsing the nasal cavities and does not allow for the liquid to enter and remain in the nasal cavities and paranasal sinuses and thus does not face the root of the problem. Although this device is supposed to provide liquid in a more controllable way, if it is to be used with a delivering probe, like the one described in US 2017/0340869 which blocks the nostrils in order for the liquid to reach the paranasal cavities, the continuous flow would probably cause choking to the user.

Consequently, new devices for dispensing a liquid solution, which make it possible to fill the nasal cavities with a liquid solution, thereby reaching the paranasal sinuses and covering the whole nasal mucous membrane surface while avoiding the solution to run back into the pharynx, are desirable.

Summary

The proposed device hereof may provide for cleaning and / or disinfecting the nasal cavities and paranasal sinuses and may also achieve injection of a liquid solution to the paranasal sinuses for the treatment of sinus infections.

To this aim, according to an example, the nasal liquid dispenser device for dispensing a controlled quantity of a liquid solution to nasal cavities and / or the paranasal sinuses of a user, is comprising:

- a liquid solution holding cylinder having a distal and a proximal end and containing a quantity of liquid solution to be dispensed; the cylinder comprising two cannulas arranged at its distal end for dispensing the liquid solution to both nasal cavities simultaneously;

- two resilient nostril plugs to seal the nostrils upon application therein, having a distal and proximal end; the plugs comprising coupling means configured to be mounted on the cannulas of the liquid solution holding cylinder and connected to a discharge orifice arranged at the distal end of the nostril plugs;

- a piston mounted in the cylinder and comprising elastic piston seals to oDer sealing on the liquid solution holding cylinder; the piston is designed to slide in an axial direction relative to said cylinder; and

- an actuator mounted with the piston and configured to move the piston along the inside of the cylinder upon manual actuation of a user. The device is formed in such a way to administer a liquid solution into the sinus cavity, sinus ostium, and / or nasal passage to treat a paranasal sinus condition.

The liquid solution holding cylinder may comprise a saline solution for bathing the nasal and sinus cavities to wash away encrusted mucous, irritants, and foreign particles for the purpose of improving airflow and relieving nasal congestion. However, the cylinder may also contain other liquid solutions, such as medicinal solutions, e.g. antibiotic solutions, for the upper respiratory system or liquids containing extracts of herbal plants which may also or alternatively be beneficial for the upper respiratory system.

Many existing devices use various techniques but only partially achieve a cleaning of the nostrils and do not succeed in injecting, in a controlled manner, therapeutic solutions to the paranasal sinuses.

The filling of the paranasal sinuses may be achieved with the use of the proposed device. The liquid solution is provided to the nasal cavities through the resilient nostril plugs, designed to lock into the nostrils, generating an airtight seal between the plugs and the nostrils, and triggering a swallow reflex that raises the soft palate, sealing off the nasal cavity and exerting pressure to the liquid that may then find an escape route through the paranasal sinus passageways and into the paranasal sinuses.

The shape, form and size of the nostril plugs is advantageous for the proper functioning of the nostril plugs. The nostril plugs are designed to be bell-shaped to follow the shape of the nose and lock into the inner cavity as soon as they are pressed in the nose. A further advantageous aspect of the nostril plugs in their design is the angled arrangement of the same to correspond with the angled distribution of the nostrils of a user, so that they offer perfect adaptation and ergonomics to the human nose but also offer comfort and safety in the nasal cavity.

The use of such a system makes easier the delivery of liquid to the paranasal sinuses, since the nostril plugs are fitted in the nostrils blocking them and not allowing the fluid to exit the nose. Treatment or cleaning of the paranasal sinuses cannot be delivered simply by rinsing the nasal cavities, and requires an advanced quantity of fluid to be held in the nasal cavities, which is succeeded by prohibiting the fluid to exit the nasal cavities until the treatment is completed.

By holding, and gently pressing the actuator, the piston slides into the cylinder, thus dispensing the liquid solution to the nasal cavities. The quantity and rate of pouring of the liquid solution may be regulated by the user. Also, due to the fact that the quantity of fluid in the cylinder corresponds to the quantity of fluid that is required to fill both the nasal and the paranasal cavities of a user, the user knows that when the fluid is over, he / she has received the whole treatment.

The shape and design of the piston and the actuator does not allow the user to return the piston to its original position. In case the user tries to refill the device with a solution, it will not be possible because when the actuator is moved in the opposite direction, apart from the cylinder, it will detach from the piston and the device will cease to function. The actuator of the piston of the device is moveable with the pressure of the finger at the extreme point of the container by dragging the piston together inwards. The two components, the actuator and the piston, are not permanently attached (e.g. glued) together so that during use the actuator pushes the piston inside the chamber but when the actuator tries to return it detaches from the piston and the piston cannot be returned to its original position (the one before pressure was applied). With the complete movement of the actuator and the piston, both components are inside the chamber. At this position the user is not able to hold with his fingers the actuator or try to return the piston to its original position. All of the above are intended to prevent the user from refilling the device with other solutions or to reuse the device in general, e.g. with third- party or unauthorised solutions.

The device is designed as a portable single-use device with a disposable configuration, assembled as a hand-held device for convenient lifting and disposal against the user's nostrils, which is easy to use and allows for self-administration.

Brief description of the drawinos

Non-limiting examples of the present disclosure will be described in the following, with reference to the appended drawings, in which:

Fig, 1 is an exploded view of a device for dispensing a liquid solution into the nasal cavities and / or paranasal sinuses according to an example hereof;

Fig. 2 is a partial view of the inside of the cylinder of the device corresponding to Fig. 1 , for showing internal elements;

Fig. 3 shows a detail of the upper part of the cylinder and the nostril plugs of the device corresponding to Fig. 1 ;

Fig. 4 shows the arrangement of the nostril plugs relative to the nose of a user and relative to each other. Detailed description

Fig. 1 is an exploded view of a disposable nasal liquid dispenser device for administering a liquid solution to the nasal cavities and / or paranasal sinuses of a user according to the present invention. The device includes a liquid solution holding cylinder 1 having a distal and a proximal end and containing a quantity of liquid solution to be dispensed. The cylinder 1 comprises two cannulas 2 arranged at its distal end for dispensing the liquid solution simultaneously and in a controlled manner, in equal and fixed doses, to both nasal cavities of a user.

The liquid solution holding cylinder 1 has two radially extending shoulders 3 arranged at its proximal end designed for holding the device during use. The device further includes two resilient nostril plugs 4 having a distal and a proximal end and designed to seal the nostrils upon application therein.

As shown in Figs 2 and 3, the nostril plugs 4 are designed to be soft and comfortable, having a hollow interior 11 comprising coupling means 6 configured to be mounted on the cannulas 2 and said coupling means 6 connected to a discharge orifice 5 arranged at the distal end of the nostril plugs 4.

In a preferred embodiment, the nostril plugs 4 are made from LDPE low density polyethylene. The nostril plugs 4 are bell-shaped to lock into the nose.

In an embodiment, the device is provided with different size nostril plugs to suit all users.

An important part of the nostril plugs 4 in their design is the arrangement of the same with regards to the nose of a user to offer perfect adaptation and ergonomics to the human nose. The nostril plugs are designed to rest in an angle a1 relative to the nose of a user of between 130 ^e and 140 ^e , when mounted on the cannulas 2, as shown in Fig. 4.

In a preferred embodiment the angle a1 is 135 degrees.

The nostril plugs 4 have a relative angle a2 between them of between 15 and 20 degrees. The nostril plugs 4 may be affixed to the cylinder 1 by means of a snap-fit system 9. The snap- fit system is designed for mating together two rods arranged at the distal end of the cylinder 1 with a groove arranged in each of the nostril plugs coupling means 6, respectively.

A piston 7 is mounted in the proximal end of the cylinder 1 and designed to slide in an axial direction relative to said cylinder. The piston comprises elastic piston seals to oDer sealing and insulation of the liquid solution contained in the liquid solution holding cylinder 1 till the moment of its use.

An actuator 8 is mounted with the piston 7 and configured to move the piston along the inside of the cylinder 1 upon manual actuation of a user on actuation surface 10. Said actuation surface 10 is sufficiently wide to support an average human thumb, by which the dispenser is actuated.

The actuator 8 is designed to detach from the piston 7 when moved in an opposite direction with regard to the liquid solution holding cylinder 1 , preventing the user from returning the piston to its original position.

By holding, and gently pressing the actuator surface 10, the piston 7 slides into the cylinder 1 , thus causing the liquid solution to flow through two holes 12, arranged in the inside of the cylinder 1 , into the cannulas 2 and through the discharge orifices 5 of the nostril plugs into both nasal cavities of a user simultaneously. The quantity and rate of pouring is regulated by the user.

During use, the user inclines the head forward to avoid passage of the liquid to the pharynx. Then, liquid is administered by pressing the actuator surface multiple times until the level of the provided solution reaches slowly to the plane of the soft palate. Then the user may try to swallow or the reflex of swallowing may be triggered. The reflex movement of swallowing may be performed due to the stimulation of the soft palate by the intranasal liquid or therapeutic solution even though there is no bolus in the mouth for swallowing. To perform the swallowing reflex the soft palate may move upwards and frontwards. The available space may thus be reduced and the level of the liquid or solution may be raised and cover the orifices of the ducts of the paranasal sinuses. At the same time, the forward movement of the soft palate may push air towards the surface of the solution. Consequently, pressure may be exerted on the solution to push it towards the nostrils' openings. Because the nostrils' openings are blocked by the intranasal parts of the device, the solution may seek escape through the orifices of the ducts of the paranasal sinuses. In repetition of the swallowing movement the liquid may find an escape route through the paranasal sinuses' ducts, while the user may press the actuator surface of the device to slowly replenish the quantity of the solution so that the level of the solution remains at the level of the soft palate and maintains the stimulation of the soft palate.

The perfectly tolerable use of the device may give the user the possibility to use the therapeutic process with ease, even when at work or while sitting on a couch (e.g. while watching TV), for as long as a user wants, providing an effective method. The friendliness of a prolonged therapeutic use provides the necessary time for the therapeutic solution to act during a necessary time to maximize the therapeutic result in the nasal and paranasal chambers. The time may range between five (5) and fifteen (15) minutes. However, in some cases even longer periods of half an hour may be beneficial so that the therapeutic effect of the liquid may take place.

The end result may provide an effective solution desired and long sought after by the medical community and users. It may be made possible by the combination of characteristics of the proposed devices and/or methods. That is, the device may provide a complete sealing of the nostrils, thus provoking the swallowing reflex when sufficient liquid is introduced in the nostrils.

Moreover, proper obstruction of both nostrils provided by the use of the proposed devices and/or methods, may allow the solution to remain in the nostrils and in the paranasal sinuses for as long as the user may wish, thereby providing the necessary time so that the therapeutic and/or cell-regenerative and/or healing properties of the medicine or of the hypertonic liquid (e.g. saline or sea water) or of the extracts of aromatic plants to give results.

Therefore, the therapeutic result for the user or patient may depend on the proper application of the process that is provided by the proposed devices. It is also mentioned that an application of the solution to the nostrils may be performed in a soft and totally controllable manner and in small doses. This may in some applications be achieved by the device construction that may provide solution in such a way that with each application (pressure) only a small controlled quantity may be provided to both nostrils.

While the examples have been described in detail in the foregoing description, the same is to be considered illustrative and not restrictive in character, being understood that only some examples have been shown and described and that all changes and modifications that come within the spirit of the examples are desired to be protected. While said particular examples of the present disclosure have been described, it would be obvious to those skilled in the art that various other changes and modifications may be made without departing from the spirit and scope of the disclosure. It is therefore intended to cover in the appended claims all such changes and modifications are within the scope of the disclosure. REFERENCES

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