Description

An Applicator Assembly for Hygienic-medical Irrigation, in particular for Vaginal Irrigation.

Technical Field

The invention relates to an applicator assembly for hygienic-medical irrigation, in particular for vaginal irrigation.

Background Art

The prior art has for some time comprised a flexible container, containing a liquid substance for irrigation, closed by a cap affording an hole internally of which a cannula can slide, the cannula having an end which is external of the container and a further end which is internal of the container. The internal end of the cannula exhibits a bottom valve which at an end thereof incorporates a button obturator which seals against the internal base of the cannula and can slide so as to free the end. The external end is shaped and exhibits passage holes which enable passage of the liquid contained in the container when the bottom valve on the internal end of the cannula is open. The applicator assemblies are sold with the cannula inserted in the container with the exception of its external shaped end, and with the bottom valve closed. At moment of use, the cannula is made to slide in extraction through the hole in the cap up until when the button obturator of the bottom valve comes into contact with the cap and exits from the end of the cannula, freeing the cannula and enabling passage of the liquid into the cannula. The liquid exits from the holes in the external end of the cannula (which is inserted into

the orifice to be treated) by applying a pressure on the container which, as mentioned, is made of a flexible material, generally soft plastic, and functions as a sort of pump.

The major drawback the known containers exhibit is that the bottom valve does not always guarantee a seal and the liquid contained in the container can exit through the cannula at inopportune times. Further, the obturator of the valve can at times exit completely from the cannula and provoke an undesired excessive flow of liquid through the cannula. A further drawback is that the external surfaces of the cannula, which come into contact with the inside of the orifice during the treatment, exhibit small die burrs (in particular at the injection openings of the die in which they were made) which can irritate the orifices under treatment.

The aim of the present invention is to obviate the above drawbacks, by providing an applicator assembly which ensures seal during non-use of the applicator assembly and regular flow of liquid when being used.

A further aim of the present invention is to provide an applicator assembly which, during use, limits the irritation to the parts to be treated. An advantage of the present invention is to provide an applicator assembly the realisation of which is versatile and economically advantageous. A further advantage of the present invention is to provide an applicator assembly which is easy to use. Disclosure of Invention

Further characteristics and advantages of the present invention will better emerge from the detailed description that follows of a preferred embodiment of the applicator assembly of the invention, illustrated purely by way of non- limiting example in the accompanying figures of the drawings, in which:

Figure 1 is a section in vertical elevation of the applicator assembly of the invention;

Figure 2 is an exploded view of various parts constituting the applicator assembly of the invention; Figure 3 is a section in vertical elevation and in enlarged scale of a detail of figure 1 of the sealing system of the applicator assembly of the invention, in an open position;

Figure 4 is a section in vertical elevation, in enlarged scale, of a detail of figure 1 of the sealing system of the applicator assembly, in a closed position. The applicator assembly of the invention is used for hygienic-medical irrigations, and in particular for vaginal irrigation.

The applicator assembly comprises a flexible container 1 containing a liquid substance for irrigation treatment; the container is made, like known containers, of a plastic material which is very soft in order that it can be compressed and function, as will be better described herein below, as a sort of pump.

A closure cap 2 is provided on the container, which cap 2 is constrained on the neck of the container and which cap 2 is provided with a hole 3. A cylindrical cannula 4 is inserted sealedly slidably in the hole 3; the cannula 4 exhibits an external part 4a, external of the container, which projects outwardly and remains external of the container, and an internal part 4b, which is arranged internally of the container but which following a sliding of the cannula in the hole is partially extracted from the container to enable use of the applicator assembly. To improve the seal between the cannula and the hole, a plurality of reciprocally parallel seal rings can be provided on the internal surface of the hole, the seal rings being fashioned directly during the forming of the cap.

Passage holes 6 are afforded in the external part 4a, which holes are always free and which holes enable passage of the liquid contained in the container towards the outside. The external part 4a of the cannula further comprises a crown 4d, made of a soft plastic material by multiple injection molding together with the external part 4a; the crown 4d, which has a greater diameter than the diameter of the remaining external part 4a, surrounds the upper part of the external part 4a while leaving the holes 6 unencumbered. The presence of the crown 4d, which is made of a softer material than the material the remaining external part is made of, limits the irritations caused by the cannula during use thereof, and protects the holes 6 against both the undesired inlet of external fluid into the cannula and against possible blocking of the holes 6 during use of the container.

The external part 4a and the internal part 4b of the cannula are made, differently to what occurs in known applicator assemblies of this type, of two distinct parts. The two parts are insertable one in another, the first part internally of the second part, and are sealedly slidable to one another. Insertion of the external part into the internal part is however only partially achieved as the zone of the external part bearing the crown 4d is always external to the internal part of the cannula, as the diameter of the crown 4d is greater than that of the remaining part of the external part 4a, and is thus not insertable in the cannula.

An annular projection 8 is fashioned on an end of the external part 4a which is inserted in the internal part 4b, while at an intermediate zone of the internal part 4a a cylindrical recess 9 is afforded, having a same diameter as an external diameter of the annular projection 8 and being axially longer than the axial length of the projection 8. When the external part 4a is inserted in the internal part 4b the cylindrical recess 9 receives the annular projection 8 and

enables it to slide internally thereof (and therefore enables the sliding of the external part 4a with respect to the internal part 4b) between a position of maximum introduction of the external part 4a in the internal part 4a in the internal part 4b and a position of maximum extraction of the external part 4a from the internal part 4b.

For reasons which will be more fully described herein below, the internal part 4b of the cannula slides more easily internally of the cap with respect to the sliding of the external part 4a in the internal part 4b; this might be easily obtained by creating a greater degree of friction in the contact between the external part 4a and the internal part 4b with respect to the friction between the cap 2 and the external part 4a.

The applicator assembly further comprises a first valve 5 which is arranged in the cannula 4 and prevents a flow of liquid through the cannula. The first valve 5 is housed internally of the recess 9 and assumes an open position A in which it allows passage of the liquid through the cannula, which is obtained when the external part 4a is in _. the position of maximum extraction, and a closed position B, in which it prevents passage of the liquid through the cannula, which is obtained when the external part 4a is in the position of maximum introduction. The first valve 5 comprises an annular obturator 5a which is fixed with respect to the internal part 4b of the cannula and which has an external diameter which is equal to the internal diameter of the external part 4a of the cannula; the obturator 5a is solidly connected to a cylindrical support 10, which is lodged internally of the internal part 4b of the cannula and is provided with unobstructed axial passage holes 10a. The obturator and the support are preferably realised by molding in a single piece.

The obturator 5 a is arranged such as to be internal of the external part 4a, to close the passage through the cannula, when the external part 4a is in the position of maximum introduction; the obturator 5 a, on the other hand, is external of the external part 4a when the external part 4a is in the position of maximum extraction. The second position, which is reached following an upwards sliding of the external part 4a with respect to the internal part 4b, is such that the obturator 5 a is in the internal part 4b, and does not close the internal part 4b as the internal diameter of the internal part 4b is greater than the internal diameter of the external part 4a, and therefore greater than the diameter of the obturator 5a.

The applicator assembly further comprises a second single-acting valve 7 fashioned superiorly of the obturator 5a of the first valve; the position of the second valve 7 is such that it is always arranged internally of the external part 4a, whatever the position of the external part 4a. The valve 7 is conformed and arranged such as to allow passage of liquid from inside the container towards the outside thereof and to prevent passage of liquid from the outside towards the inside of the container. In particular, the single-acting valve comprises a spherical lens 7 which is made of a flexible material and which is superiorly connected to the obturator 5 a by the spherical surface thereof, a diameter of which is equal to or greater than the internal diameter of the external part 4a of the cannula. The spherical lens 7 is also preferably made by molding in a single piece with the support 10 and the obturator 5 a of the valve 5. With this conformation, the lens 7 closes on itself, thus opening the valve 1 when invested by the liquid from the lower part and allowing passage of the liquid from inside the container towards the outside thereof. Conversely, the lens 7 widens, closing the valve, when invested by a fluid coming from

outside and, as it comes into contact with the internal wall of the external part 4a of the cannula, blocks the passage of the incoming fluid. The lower end of the internal part 4b of the cannula comprises an annular projection 4c, having an external diameter which is greater than the external diameter of the cannula, the function of which will better emerge from the description herein below.

The applicator assembly further preferably comprises a closing cover 20 which is coupled to the container 1 by a threaded coupling and which is provided with a security strip 20a. When the applicator assembly is whole, i.e. prior to first use thereof, the cover 20 completely covers both the neck of the container and the external part 4a of the capsule projecting from the cap 2, protecting them from external agents and providing proof that the applicator assembly is as yet unopened. For reasons that will better emerge herein below, the part of the cover which covers the external part 4a of the capsule projecting from the cap 2 is deformable by squeezing.

The container 1 comprises, below the mouth thereof, a zone Ia, conformed as a cylindrical bellows, which allows angular movements with respect to the vertical of the neck of the container, and therefore the cannula. As mentioned, the cannula is made of a plastic material in two distinct parts; this enables injection molding to be used for making them, and thanks to the injection molding technique, simpler dies leading to realising very smooth surfaces and therefore not irritating and not exhibiting die burrs, which are exhibited in cannulas of known type. It is further possible to have considerable versatility as in order to use the cannula in containers of different sizes, it is sufficient to modify only the internal part 4b, leaving the other parts unchanged, leading to considerable manufacturing savings.

As for assembly, the support 10 on which the obturator 5 a is fashioned is inserted into the internal part 4b; the resulting group is then inserted from below into the cap 2; thereafter the external part 4a is inserted into the internal part 4b up until when the annular projection 8 contacts the lower part of the recess 9. This operation presents no difficulties, even if the annular projection 8 has the same diameter as the recess 9, and therefore slightly greater than the internal diameter of the remaining zone of the internal part 4b, as the deformability of the plastic materials which the various parts are made of allows for insertion with slight forcing. The cap 2, with the cannula inserted, is then forced onto the neck of the container which has been previously filled with the treatment liquid. To securely fasten the cap to the neck of the container, an annular projection 2a is fashioned on the external part of the cap, which projection 2a inserts in an annular recess 2b provided in the internal surface of the container neck. Finally, the protective cover 20 is mounted on the upper part of the assembly. The applicator assembly is thus ready to be sent for use. This conformation is illustrated in figure 1 and the position of the valve is illustrated in detail in figure 4; in this conformation, the valve closes the cannula and prevents exit of the liquid from the container. On first use, the cover 20 is unscrewed to cause breakage of the easy-break ribs holding the security strip 20a in place. The cannula is then extracted in an externalwise direction by pulling on the external part 4a thereof. To prevent direct contact of he external part 4a with the fingers of the hands, this operation can be done using the upper part of the cover 20 as protection, as the cover 20 is made of a material which is deformable by crushing.

The internal part 4b of the cannula, which slides more easily internally of the cap with respect to the external part 4a located inside the internal part 4b, is

made to slide out of the cap 2. The exiting of the internal part 4b is stopped when the lower annular projection 4c strikes the cap 2. By continuing to pull, the external part 4a of the cannula slides internally of the internal part 4b up until the cannula reaches the conformation A of maximum extraction, illustrated in figure 3. In this conformation, the obturator of the valve 5 is no longer in contact with the internal wall of the external part 4a and does not close the cannula, thus allowing liquid to exit the container; the liquid, pushed into the inside of the cannula by the squeezing of the container, enters the internal part 4b of the cannula through the free holes 10a, the valve 5 and the single-acting valve 7, and exits the cannula through the holes 6.

The applicator assembly is thus ready to perform its function, which is carried out by "pumping" the liquid by means of applying pressure on the walls of the container; note that the single-acting valve 7, which allows free passage of the liquid internally of the container towards the outside, prevents aspiration of fluid from the outside which might be caused by the release of the squeezing pressure on the container after the pumping operation. The cylindrical bellows conformation of the zone below the mouth of the container 1 allows angular movements of the container neck and the cannula to be made, and facilitates use of the applicator assembly.

With respect to the known applicator assemblies in which the obturator of the valve is arranged on the bottom of the cannula and is opened by contact with the cap, the applicator assembly of the invention exhibits various considerable advantages. Primarily, it is practically impossible to extract the cannula from the container completely, which sometimes happens with known containers and which is not at all desirable, as the projection 4c can be realised with a very much

larger diameter to that of the internal part 4b which is inserted in the cap by the superior end thereof; the size of the projection 4c securely prevents the cannula from exiting completely. Further, the valve obturator is contained internally of the cannula and cannot be damaged, which sometimes happens with known containers, for example during the packaging operations, and leads to loss of seal in the valve.

Finally, with the applicator assembly of the invention it is not possible for the obturator of the valve 5 to exit the cannula, which at times happens with known applicator assemblies which exhibit the obturator arranged at the bottom of the cannula, and which is opened by exerting a pushing pressure on the cannula, which if excessive or too protracted in time can cause the valve to exit the cannula.