Patent Application
20240000658
The present invention relates to a device for controlled administration of a liquid solution to the nasal cavities and 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.
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 tract1,2. Hypertonic 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 concentration4. 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 medications5.
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 eustachian 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.
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 device for controlled provision of a liquid solution to nasal cavities and paranasal sinuses of a user, is comprising:
The device is manual and has no electronic or electrical components. It has a special design to give the user the appropriate ergonomics while it is reusable with the use of different cartridges.
The external housing of the device is designed to offer significant time saving of assembly, it is made of a plastic material, it does not contain third-party materials, such as glue or screws, and holds the air system and the pump system through a snap-fit system having a subframe that closes all components internally.
The ergonomic design of the external housing provides proper driving of the cartridge and allows for correct use of an air bulb, comprised within the air system and located at the bottom of the device, to inject air at the beginning of the treatment.
The device is intended to initially inject air, or other fluid or gas, into the nostril plugs system, and hold the air, by means of a one-way valve, so that two expandable portions of a nostril plugs component, comprised within the nostril plugs system and having a network of internal tubes, remain inflated and block the nose and the user from breathing. Then, by mechanical movement of the cartridge, the pump system is forced to channel the liquid solution and fill with said solution the nasal cavities.
By means of a two-line resilient tube that has an air line and a liquid line, the device is able to inject air coming from the air system to the nostril plugs component, creating an air-tight seal with the nostrils, and to pump the liquid solution, through the nostril plugs system and into the nasal cavities.
The expandable portions of the nostril plugs component are designed to be bell-shaped to lock into the inner cavity as soon as they are placed on the nose. An important part of the nostril plugs component in its design is the angle between the two bell-shaped expandable portions so as to offer perfect adaptation and ergonomics to the human nose but also offer comfort and safety in the nasal cavities.
The nostril plugs system is connected to the pump system by means of a plug-in mechanism which makes the attachment and detachment of the nostril plugs system to the device easier for the user.
The use of such a device makes easier the delivery of liquid to the paranasal sinuses, since the expandable portions of the nostrils plug component are fitted in the nasal cavities blocking them and not allowing to 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 accomplished by prohibiting the fluid to exit the nasal cavities until the treatment is completed.
The cartridge comprises a lid which is locked with a container that holds a liquid solution and all the components are insulated internally ensuring airtight operation and protection from the environment. The cartridge also comprises a safety mechanism to protect the connection area of the cartridge from dirt and to certify that the cartridge has not been used before. By breaking the safety mechanism, the cartridge is ready for use until the whole solution is emptied and cannot be reused or refilled again by the user.
The operation of the cartridge is based on the suction of the pump system. When the cartridge is connected to the pump system, a watertight chamber is created which also acts as a dosimeter of the solution during use. The pump system pumping solution from the cartridge forces a piston comprised within the container of the cartridge to move upwards due to the vacuum created inside the container and a one-way valve mechanism, also comprised within the container, doesn't allow the liquid solution to return to the container.
The container 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 container may also contain other liquid solutions, such as medicinal solutions, i.e. 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.
Non-limiting examples of the present disclosure will be described in the following, with reference to the appended drawings, in which:
The external housing 1 defines an inner space comprising an air system 2 for injecting air to a nostril plugs assembly 9 and a pump system 3 for pumping a liquid solution to the nasal cavities.
According to a preferred embodiment of the present invention, the external housing 1 is made of a plastic material.
As shown in
In a preferred embodiment, the valve plunger 24 is shaped like a ball and the actuator sealing means 29 is an O-ring.
In a preferred embodiment, all of the air system 2 components are made of plastic and have a special design that aims to create the right position for the air bulb 20 and the actuator 28 to help the user ergonomically during the treatment.
The air system 2 is built in such a way that the device doesn't comprise any electronic or electrical parts and is completely autonomous.
As shown in
The cartridge lid 37 comprises a safety lid 38 to protect the connection area of the cartridge from dirt and to certify that the cartridge has not been used before.
The container 32 holds approximately between 50 ml and 150 ml, which according to medical research is the quantity of fluid required to fill both the nasal and the paranasal cavities of a user or patient. Therefore, this is the required quantity of fluid to deliver a proper treatment of this kind.
In a preferred embodiment, the container holds 50 ml of a liquid solution.
As shown in
As shown in
As shown in
The nostril plugs assembly 9 comprises a plastic accessory 39 to connect the nostril plugs assembly to the tube 7; two Y-shaped internal components 39a, 39b that distribute the liquid solution and air in a nostril plugs component 40; and a support 41 that holds all the nostril plugs assembly components together by means of a snap-fit technology and creates mechanical tightening to create an airtight chamber inside.
The nostril plugs component 40 has two bell-shaped expandable portions 42, 43, as shown in
In a preferred embodiment of the present invention, the angle α is between 130 degrees and 140 degrees, and most preferably 135 degrees.
The two expandable bell-shaped portions 42, 43 of the nostril plugs component 40 comprise a network of internal tubes that allow the expandable portions to swell with the air coming from the air system and create an airtight lock with the user's nostrils.
The two-line resilient tube 7 has an air line 50 to inject air to the nostril plugs component 40 and a liquid line 51 to deliver the liquid solution from the cartridge 4 to the nasal cavities through an orifice 52 of the two bell-shaped expandable portions of the nostril plugs component 40.
As shown in
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 devices may provide a complete sealing of the nostrils, in some implementations thus provoking the swallowing reflex when sufficient liquid is introduced in the nostrils.
Furthermore, the way that the nasal cavities are sealed may not be a simple sealing but may produce some further effects: The expansion of the intranasal part of the device in the nostril may be disposed to push outwards the alar sidewalls of the nostrils which results in a widening of the nasal vestibule, and in some implementations thus freeing the nasal conchae and revealing the ducts of the paranasal sinuses which may facilitate the introduction of liquid to the paranasal sinuses.
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 saline (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 cartridge construction that may provide solution under pressure 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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20212852.6 | Dec 2020 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/084062 | 12/2/2021 | WO |
