WO2022003592A1

WO2022003592A1 - Improved nasal atomizer

Info

Publication number: WO2022003592A1
Application number: PCT/IB2021/055866
Authority: WO
Inventors: Fara VALLEFUOCO
Original assignee: Adl Farmaceutici S.R.L.
Priority date: 2020-07-01
Filing date: 2021-06-30
Publication date: 2022-01-06
Also published as: IT202000003820U1

Abstract

A syringe nasal atomizer, aimed at medicating the airways, of the type which allows topical treatment s of the nasal and sinus cavities, introducing the liquid contained in the syringe into a nostril by pushing the piston, characterized in that, unlike what is known, in addition to the ostiomeatal complex (COM) and the sphenoethmoidal recess (RSE), it also allows the administration of a liquid intranasally on the nasopharynx (RF), thus ensuring a modular and progressive dispensing for the entire application time. Such a result is obtained as the atomizer is structured so as to allow the formation of liquid particles or micelles of a size between 70 and 10 microns, with an oversized cumulative percentage of mass with respec t to 10 microns of over 98%, which experimentally allows the same micelles to reach the nasopharynx in order to medicate the whole rhino-sinus-pharyngeal district, but minimizes the risk that they can reach the lower respiratory tract.

Description

IMPROVED NASAL ATOMIZER

DESCRIPTION

The present invention relates to a syringe nasal atomizer, aimed at medicating the airways, of the type which allows carrying out topical treatments of the nasal and sinus cavities by introducing the liquid contained in a syringe into a nostril by pushing the piston, the peculiar feature of which lies in that, unlike what is known, in addition to the ostiomeatal complex (COM) and the sphenoethmoidal recess (RSE), it also allows the administration of a liquid intranasally on the nasopharynx (RF), which structurally forms part of the respiratory system, ensuring a modular and progressive dispensing for the entire application time. It should be kept in mind that the nasopharynx, where the adenoids are also found, is the site where the first physio-pathological step of descending laryngeal - tracheal - bronchial diseases begins. Nasopharyngeal inflammation/infection is also implicated in the pathogenesis of otitis media. Furthermore, the nasopharynx is the site of the so-called "microbiological bank" as well as being the place where bacterial biofilms are formed.

Therefore, having a syringe nasal atomizer capable of ensuring a modular and progressive dispensing of a medicament in the form of an aerosol on such a site for the entire application time is particularly significant, where the distribution of the emitted aerosol particle size minimizes the risk that it can reach the lower respiratory tract.

Such a result was obtained by developing an atomizer structured so as to allow the formation of liquid particles or micelles of a size between 70 and 10 microns, with an oversized cumulative percentage of mass with respect to 10 microns of over 98%, which experimentally allows the same micelles to reach the nasopharynx in order to medicate the entire Rhino- Sinus-Pharyngeal district, but without the danger of being inhaled.

BACKGROUND ART

Several devices are known, substantially comprising a soft conical adapter which ensures the seal on the nostril and which ergonomically adapts to the nostrils of adults and children, and a syringe (without needle) which, by forcefully pushing the piston, allows the contained liquid to be atomized, forming very small particles which stop exclusively in the upper respiratory tract and are very useful for effectively and especially quickly eliminating excess mucus from the nose.

However, the problem of having atomized particles of size such as to allow reaching the nasopharynx, simultaneously ensuring amplitude, homogeneity, and depth of the atomized flow, has never been addressed. From the tests carried out it has been verified that such a result can only be achieved with micronized water in aerosol where only 1.7% has a size below 10 pm and only 33.7% has a size below 50 pm.

Therefore, it is the task of the present invention to meet the aforementioned needs by providing a syringe nasal dispensing device, which is also usable for pediatric use, for an atomization aimed at medicating the entire Rhino-Sinus-Pharyngeal district, without reaching the lungs.

It should be kept in mind that atomization is meant as the transformation of water into microscopic droplets, using high pressure systems which impart high speeds to the water: at the outlet of the nozzle, the jet is transformed into many small droplets. In practice, such a result is obtained by forcing the liquid to pass through an orifice having a very narrow passage section. The narrower the passage section of the orifice, the greater the pressure to which the liquid is subjected.

According to the present invention, atomized liquid particles are obtained, in which the median volume diameter (MMD) is equal to 68.9 ± 6.7 microns and the size profile of the aerosol micelles has a homogeneous distribution for all size ranges during the entire volume of atomized liquid, by providing in combination:

A) An atomization device comprising:

An outer part consisting of an ogival cap, morphologically adapted to be inserted into a nasal cavity, open at the bottom and containing a tubular duct of smaller diameter therein, which leads to a dispensing hole, positioned centrally on the upper end thereof; an atomizer insert available on the market, such as Silgan 230220, manufactured by the German company SILGAN Dispensing Systems Hemer gmbh, which is inserted into said ogival cap by virtue of the presence of said tubular duct, so that the head thereof which is provided with a single-hole atomizer comes to be found inside the dispensing hole of the same ogival cap and closes the lower end with the circular cylindrical base thereof, of larger diameter; a connecting element or adapter between said atomizer and the syringe, provided with a male-female Luer lock connector on one side for the connection with the atomizer, and a tubular connector on the opposite side, adapted to be inserted into the syringe connector and provided with two protruding tabs capable of guiding the screwing, and

B) A syringe, without needle, provided on the cone thereof with a male-female Luer lock connector fitted with grooves where said tubular connector of the connecting element is screwed.

Cone of the syringe indicates the exit point of the liquid or the connection point of a spike, a needle, or a butterfly: there can be two types, the simple one or the one which allows a firmer coupling, referred to as a Luer lock. The difference depends on the safety need of the connection: in case of high operating pressures, as in our case, it is necessary and mandatory to use a Luer lock type cone.

In this regard, it should be kept in mind that the Luer cone is a standardized system of small-scale fluid fittings used to make leak-free connections between a male conical connection and the female coupling part thereof on medical and laboratory instruments, including tips and hypodermic needles for syringes or needles or taps and needles.

As mentioned, the injector used, which is not the subject of the present invention, is a cylindrical injector which has a slightly flared shape and ends in a bottleneck, where the outlet orifice is unique and has a diameter of about 2 mm and therefore a passage section of 3.20-3.14 mm².

The liquid to be atomized reaches such an outlet orifice through a path which has a series of narrowings of the passage section starting from a female connector, provided with a central orifice, in the form of an inverted cup, in which the connecting element with the syringe according to the present model is engaged, the passage section of said inlet orifice in the female connector being greater than said outlet orifice.

As for the connecting element with the syringe, on one side the male Luer lock connector is in the form of a first open tubular duct for the connection with the Luer cone or emission duct of said syringe, and on the other side the male-female connector consists of a second tubular duct with a smaller diameter which is coaxially inserted into a sleeve of a diameter such that, by introducing said second tubular duct into the inverted drawer inside the atomizer, the outer surface is encountered, thus creating a seal.

The description of the invention will be better understood with reference to the accompanying drawings which depict, merely by way of non-limiting example, a preferred embodiment.

In the drawings:

Fig. 1 is an elevation view of the atomizer device as a whole according to the model mounted on a syringe with central Luer lock;

Fig. 2 shows, in longitudinal section, the connecting element between the ogival nozzle and syringe, with an upper male-female Luer lock connector and a lower male Luer lock connector with two tabs for screwing;

Fig. 3 is a longitudinal sectional view of the ogival part highlighting the inner tubular duct adapted to receive the Silgan atomizer and provided at the top with the hole where the upper end of said atomizer abuts for the outlet of the atomized liquid;

Fig. 3a is a longitudinal sectional view showing the ogival cap in fig. 3 with the atomizer device mounted inside and already connected to the connection in fig. 2;

Fig. 4 shows, from the front in elevation, purely as an indication, the Silgan atomizer which is mounted inside the ogival part of the preceding figures and which is not the subject of the present model;

Fig. 4a is a top perspective view of the same Silgan atomizer;

Fig. 4b is a top plan view of the atomizer in fig.

4a;

Fig. 5 is a vertical sectional view of the same Silgan atomizer.

With reference to the figures, the atomization device of the invention consists of:

A substantially ogival cap 4 with axial symmetry, morphologically adapted to be introduced into one of the user's nasal cavities, and on the beveled tip 5 of which a circular hole 6 is obtained, on the center of which the symmetry axis 9 of the cap itself passes; it is open at he bottom, and contains a tubular duct with a smaller diameter 8 therein, which leads to said dispensing hole 6 and which is intended to receive an atomizer 7, of a commercial type, for example that manufactured by SILGAN, Dispenser Systems Hemer Gmbh, with a circular bracket 10 of larger diameter, above the cylindrical spacer 11, which closes the lower end of the same cap, and which is provided with a dispensing hole with a diameter of about 2 mm and therefore a passage section of about 3.14 mm , and an adapter 14 for connecting said atomizer 7 to the syringe 20 containing the liquid to be atomized, which adapter 14 is provided with a male-female Luer lock connector 16,18 on one side and a male Luer lock connector 12 on the other, equipped with two protruding tabs 13, to guide the screwing thereof, (figs. 2, 5).

As shown in figure 5, the connection 14 comprises, in axis and in communication with each other, a first tubular part 12 with an open end, adapted to be fitted onto the male-female Luer connector 21 of the syringe 20, for the connection with the syringe itself, and a second tubular part 16 with a smaller diameter than the first part adapted to enter into a circular drawer 22 placed at the lower end of the duct 7b, where the inlet orifice opens.

By virtue of the Luer lock connectors, when the tubular part 16 of the connection 14 is coaxially inserted into the inverted drawer 22, the tubular duct 18 encounters the outer surface of the latter, thus creating a seal. In order to facilitate the operator's maneuvers of inserting and removing the connecting element 14, a gripping bracket 19 is included which protrudes laterally between the first and second tubular parts of the connecting element 14 and closes the ogival cap 4 at the bottom.

In light of the advantages highlighted by the use of the dispensing device described here, there is provided, for convenience of the operator, a kit comprising in combination said dispensing device - ogival cap and connecting element, together with a syringe provided with a male-female Luer lock connector 21.

From the above description, it is however apparent to those skilled in the art that other combinations and variations capable of achieving similar results can also be introduced, using traditional non-Luer lock syringes, without departing from the scope of the present invention, as defined in the following claims.

Claims

1) A syringe nasal atomization device, aimed at medicating the airways and administering fluids intranasally up to the nasopharynx, comprising:

A) an external part consisting of an ogival cap, morphologically adapted to be inserted into a nasal cavity, open at the bottom and containing a tubular duct of smaller diameter therein, which leads to a dispensing hole, positioned centrally on the upper end thereof; an atomizer which is inserted into said tubular duct inside the ogival cap, so that the head thereof provided with a single-hole atomizer comes to be found inside the dispensing hole of the ogival cap, and closes it, with the circular cylindrical base thereof, of larger diameter, the lower end; a connecting element between said atomizer and the syringe, provided with a male-female Luer lock connector on one side and a tubular connector on the other, and

B) a syringe, without needle, provided on the cone thereof with an emission duct adapted to be engaged in said tubular connector of the connecting element.

2) A device according to the preceding claim, characterized in that: said connecting element between the atomizer and the syringe is provided with a male-female Luer lock connector on one side and a male tubular connector on the other which is provided with two protruding tabs capable of guiding the screwing thereof, and the syringe, without needle, is provided on the cone thereof with a male-female Luer lock connector provided with grooves where said male connector of the connecting element is screwed.

3) A device according to claim 1, characterized in that the cylindrical injector which is introduced into the ogival cap has a slightly flared shape and ends in a bottleneck, where the outlet orifice has a diameter of 1.8-2.2 mm.

4) A device according to the preceding claim, characterized in that the liquid to be atomized reaches such an outlet orifice through a coaxial tubular duct of larger diameter which originates from a female connector, provided with a central orifice, in the form of an inverted cup, in which the connecting element with the syringe is engaged, the passage section of said inlet orifice being greater than said outlet orifice.

5) A device according to any one of claims 2 onwards, characterized in that in the connecting element with the syringe, the male Luer lock connector is in the form of a first open tubular duct for the connection with the emission duct of said syringe, while the male-female connector consists of a second tubular duct with a smaller diameter which is coaxially inserted into a sleeve of a diameter such that, by introducing said second tubular duct into the inverted drawer which is inside the atomizer, the outer surface is encountered, thus creating a seal.

6) A device according to any one of the preceding claims, characterized in that the ogival nozzle is made of a thermoplastic material adapted to contact the interior of the nasal cavities.