MXPA00005009A - Sprayer nozzle with closing membrane - Google Patents

Abstract

The invention concerns a nozzle for dispensing and/or dosing liquid pharmaceutical products comprising a cylindro-conical body (1) provided with a lower supporting base (13) to be connected to a reservoir capable of being pressurized and with an axial discharge conduit (10) enclosing a central core (2) and communicating, at its upper end, with a spraying nozzle and at its lower end, with the reservoir. The invention is characterised in that the discharge conduit (10) upper end is temporarily closed and sealed by a wall (111) integral with said body upper part (1a) and perpendicular to said conduit (10) by being reversibly mobile by the action of the product, said wall (111) being provided with a central orifice (110) capable of being sealed in the closing position, by the forced pressure of a pin (20) integral with the core (2), and peripherally linked to said body (1) by acoupling element (112) elastically deformable for the axial translation of said wall (111) under pressure.

Description

SPRAY NOZZLE WITH CLOSURE MEMBRANE Field of the Invention The present invention relates to a nozzle for the distribution of liquid pharmaceutical products.

Background of the Invention Traditional nozzles, such as those for nasal application, generally comprise a cylindrical body intended to be mounted by means of a splice support or connection on a reservoir capable of being put under pressure. In the body, an axial ejection duct is enclosed that encloses a central ring and communicates, on the one hand, at its upper extremity with a valve or a spray tube and, on the other hand, at its lower extremity with the reservoir through the means of pressurization and / or dosing of the product. Such nozzles are described, for example, in document W094 / 29187 or the expulsion conduit is sealed by a wall provided with a central hole which Ref.120429 cooperates in a hermetic manner with a projection and is fixed again to the nozzle by means of of deformable connection elements ensuring an axial displacement. However, with these nozzles, the bacteriological protection of the product is not reliably ensured. In fact, the valve or the spray tube do not constitute, by themselves, a mechanical barrier sufficiently effective to limit significantly or even fortiori to eliminate the risks of contamination of the product. Although the incorporation of bactericidal or antibacterial agents in the constituent material of the nozzles allows to improve the protection, the search for a fully satisfactory solution also happens and above all for the development of the mechanical means able to ensure an isolation with thrust movement of the expulsion duct in order to obtain a better confinement of the product in the tank. On the other hand, when the operation of the pressurization means require a rebalancing of the pressures between the tank and the outside, the intake of air must not be a cause of contamination or degradation of the product and must not compromise the airtightness of the product. nozzle or the quality of distribution or dosage. Finally, traditional nozzles do not have, in general, sufficient suitability to withstand any mode of sterilization. The object of the present invention is to resolve these technical problems in a satisfactory manner. This object is achieved according to the invention by means of a nozzle for the distribution and / or dosing of liquid pharmaceutical products, comprising a cylindrical body provided with a lower supporting support and connection to a reservoir capable of being put under pressure and an axial expulsion duct enclosing a central ring and communicating, on the one hand, at its upper end, with a spray tube, and, on the other hand, with its lower end, with the reservoir, characterized in that the extremity upper part of the expulsion duct is temporarily sealed by a wall that is integral with the upper part of said body and perpendicular to said duct, being reversible displaceable under the action of the product, said wall is provided with a central hole susceptible to being closed in the closed position, by the forced support of a protrusion integral with the ring, and it is fixed again R to said body peripherally by an elastically deformable link element that allows under pressure the axial transfer of said wall. According to a specific embodiment, the upper part of said body is formed of a separate hood or hatch carrying said wall and sealingly covering a coaxial sleeve integral with the lower part of said body and delimiting at least partially the part elevated of the expulsion duct. According to a variant, said wall is made in one piece with the hood or hatch of an elastomeric or elastomeric-thermoplastic material. According to a particular variantsaid hood or hatch is blocked or enclosed on said sleeve of the ratchet elements. Preferably, said sleeve is connected or connected to the lower part of said body by a transverse shoulder which forms a stop for the lower edge of said hood or hatch. According to another embodiment, the upper and lower parts of said body are manufactured in one piece by bi-injection of an elastomeric-thermoplastic material and a thermoplastic material. According to another variant, said spray tube is formed under said wall by the intercalated spaces located radially towards the outside of the periphery of said wall between the internal faces of the upper part of said body and the external envelope of said ring. According to an advantageous feature, said ring has a substantially cylindrical widened head. According to yet another variant, the central office of said wall is formed of a cylindrical andrilado while said projection has a substantially frustoconical profile. Preferably, the outer face of said wall is in contraction or retraction with respect to the upper rim of said body so that a cuvette is defined. According to yet another variant, the lower nozzle is extended downwards by a hub or bushing intended to be jammed or rolled up with the radial adjustment in the neck of the tank. According to yet another embodiment, which is applied more particularly to a peripheral distribution mode, said wall is made in the form of a membrane whose permeability allows air filtration. Preferably, said wall is made of silicone.

According to a particular variant, said ring ensures a state of pretension of the link element in the closed position. The nozzle of the invention offers a reinforced tightness of the expulsion duct avoiding, in the closing position, any penetration of bacteria or other biological contaminants. The complementary use of a bactericidal agent that acts by simple contact with the product and without migration, then allows the aseptic treatment in situ of the fraction of the product that remains confined inside the tube and in the expulsion duct, after the return to the closing position of the movable wall. In the same way, this aseptic treatment also affects the outer surfaces of the nozzle that are more exposed to the polluting media. Taking into account the absence of dead volume at the level of the mobile wall and very small volumes of the spaces intercalated inside the nozzle, the performance of the bactericidal agent is excellent and leads to the complete neutralization of the germs. When the pressurizing means used work with an air intake, the volume of the sucked air is filtered through the displaceable wall, which eliminates any risk of contamination and / or contamination. On the other hand, the mouthpiece as a whole can be sterilized by any means such as beta and gamma ionizing rays and thermal treatments at a temperature of at least 120 ° C. In addition, the spraying is of very good quality and this in a constant and durable manner because the wall as a whole moves uniformly in axial movement without lag or parasitic deformation. The nozzle of the invention can be advantageously used for the distribution and dosage of pharmaceutical products in the nasal (ENT sphere) or ophthalmic application. The invention will be better understood by reading the following description accompanied by the drawings on which: Figure 1 represents a partial sectional view of an embodiment of the nozzle of the invention; Figures 2a, 2b, and 2c represent sectional partial views of one embodiment of the nozzle of the invention, respectively in the free state then in the assembled state in the closed position then in the open position.

Detailed description of the invention The nozzle shown in Figure 1 is intended to deliver doses of a liquid pharmaceutical product used especially for the treatment of respiratory tract conditions or for ophthalmic treatments. This nozzle comprises a cylindrical body 1 provided with a lower support 13 for manual support and connection to a reservoir (not shown). The lower support 13 is itself extended to the lower part by a hub 14 intended to be encased with the radial adjustment in the cylindrical neck of a reservoir. An axial ejection duct 10 enclosing a central ring 2 made here in the form of a flat, independent cylindrical part with a widened head is carried in the body 1. According to a variant, the body 1 and the ring are manufactured in one piece. The expulsion duct 10 communicates, on the one hand, at its upper end with a spray tube, and on the other hand, at its lower end, with the tank, through the pressurization and / or dosing means (not shown). on Figure 1).

The upper extremity of the expulsion duct is sealed temporarily and hermetically by a transverse wall 111. The wall 111 is displaceable reversibly under the action of the liquid product expelled under pressure. The wall 111 is provided with a central hole 110 formed of a cylindrical adjustment sealed in the closed position, by a projection 20, of substantially frustoconical profile, integral with the ring 2. In the embodiment of Figure 1, the projection 20 becomes lodged in the calender 110 while in the embodiment of Figures 2a to 2c, the projection 20 comes in forced support against the internal face of the wall 111 on and around the calendering 110. The tube The spray pattern is preferably of the icroniebla type (denomination SOFAB) being formed under the wall 111 by the intercalated spaces comprised between the internal faces of the upper part of the body 1 and of the outer envelope of the ring 2. The wall 111 extends perpendicularly to the axis of the conduit 10 being integral with the upper part of the body 1. The connection of the wall 111 to the body 1 is carried out peripherally by means of an elastically deformable link element 112 preferably made in the form of a mantle cancel. The link element 112 has a smaller thickness than that of the wall 111 which is thus more rigid. A liquid pressure comprised between 0.1 and 10 bar generated for the manual support on the support 13 (and the actuation of the pressurizing means) is applied against the internal face of the wall 111 and forces the link element 112 to deform elastically forming thus a hinge for the wall 111. The wall 111 is then deflected upwards by an axial translation and is maintained in the substantially parallel planes and releasing the hole 110 of the projection 20 (see Figure 2c). When the liquid pressure drops, the link element 112 exerts a return force of the wall 111 towards its rest position corresponding to the hermetic seal of the hole 110. In the closed position of the embodiment of Figure 1 or all right. In the free state, in the variant of the Figure 2a, the plane of the external face of the wall 111 is in delay with respect to the curvilinear upper ridge a of the body 1 so that a cuvette is defined. This arrangement implies that the link element 112 is inclined towards the axis of the conduit 10 and downwards with an angle comprised between 0 and 60 ° while the side face of the wall 111 is bisected extending into the extension of the linking element 112. According to a variant of embodiment shown on Figure 2b, in the assembled state and in the closing position of the nozzle, there is a forced support of the projection 20 against the wall 111, which guarantees the tightness of the conduit 10 and that causes a slight displacement of the wall 111 towards the outside. According to this variant, in the closed position, the link element 112 is thus deformed and remains under restrictions while the cylindrical profile of the calender 110 becomes substantially frustoconical. Of course, the deformation domain of the link element 112 goes through the adjustment of its geometric characteristics and its modulus of elasticity. Thus, the opening pressure of the conduit 10 will depend on the area of the internal face of the inner wall 111 against which the liquid pressure and the recoil force of the linking element 112 which is forced to release the orifice 110 is exerted. Overall, from the free state (Figure 2a) to the opening position of the assembled state (Figure 2c) the wall 111 also undergoes axial translation through a pre-stressing state.

On the other hand, the operating regime of the channels and the turbulent network of the spray tube has not been disturbed by the displacement of the wall 111 because they are positioned radially outside the periphery of the link element 112. In the particular embodiment shown, the upper part of the body 1 is formed of an independent hood or hatch 11 whose upper edge has the wall 111. The hood or hatch 11 tightly covers a coaxial sleeve 12 integral with the lower part lb. of the body 1. The sleeve 12 delimits, at least partially, the elevated part of the expulsion duct 10. The wall 111 is then manufactured in one piece with the hood or hatch 11 of an elastomeric material such as an EPDM (monomer of ethylene-propylene-diene) or an elastomer-thermoplastic such as a polypropylene-EPDM blend. According to a variant embodiment, the wall 111 is made in the form of a membrane whose permeability is determined so as to ensure the filtration of the incoming air to avoid any contamination or contamination (especially bacterial) of the product following the intake of air .

Preferably, the material used to make this membrane will be silicone or an elastomeric silicone compound. The air permeability of the hood or hatch 11 made for molding from a silicone elastomer is between 70 μl / 24 hours at 800 μl / 24 hours. The hood or hatch that is possibly removable, is in a radial fit with the upper part of the sleeve 12 and is locked or closed on the lower part, for example, by means of complementary ratchet elements 113, 123. The lower part lb of the body 1 is made, preferably of polypropylene or any other material capable of withstanding a thermal sterilization treatment. The sleeve 12 is connected or connected to the lower part 2b of the body 1 by a transverse shoulder 121 which forms a stop for the lower edge 11b of the hood or hatch. According to another embodiment not shown, the upper and lower parts lb of the body 1 will be made or manufactured in one piece by bi-injection in a mold of an elastomeric material and a thermoplastic material.

Preferably, all the zones and components of the nozzle are made of materials in which an antiseptic agent (bactericidal or antibacterial) is incorporated, for example based on silver ions.

It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects to which it relates.

Having described the invention as above, property is claimed as contained in the following

Claims (13)

1. A nozzle for the distribution and / or dosing of liquid pharmaceutical products, comprising a cylindrical body provided with a support support and connection to a reservoir capable of being put under pressure and an axial injection conduit enclosing a ring central and communicating, at a first extremity, with a spray tube, and, at its other end, with the reservoir, the expulsion conduit is sealed temporarily and hermetically by a wall that is integral with said body and perpendicular to said duct, the wall is further provided with a central hole capable of being closed in the closed position, by the forced support of a projection integral with the ring, and attached to said body in a peripheral manner by an elastically deformable link element that allows, under pressure, the axial translation of said wall, characterized in that the wall is manufactured in the form of a membrane whose permeability It allows air filtration.

2. The nozzle according to claim 1, characterized in that the upper part of said body is formed of a separate hood or hatch carrying said wall and sealingly covering a coaxial sleeve integral with said body and delimiting at least partially the part elevated of the expulsion duct.

3. The nozzle according to claim 2, characterized in that said wall is made in one piece with the hood or hatch of an elastomeric or elastomer-thermoplastic material.

4. The nozzle according to claim 2 or 3, characterized in that the hood or hatch is blocked or enclosed on said sleeve by means of ratchet elements.

5. The nozzle according to claims 2 to 4, characterized in that said sleeve is connected to the body by a transverse shoulder that forms a stop for the edge of said hood or hatch.

6. The nozzle according to one of the preceding claims, characterized in that the body is made or manufactured in one piece by bi-injection of an elastomer-thermoplastic material and a thermoplastic material.

7. The nozzle according to one of the preceding claims, characterized in that said ring has a substantially cylindrical widened head.

8. The nozzle according to one of the preceding claims, characterized in that the central hole of the wall is formed of a cylindrical calendering while the projection has a substantially frustoconical profile.

9. The nozzle according to one of the preceding claims, characterized in that the external face of the wall is in reduction or delay with respect to the upper rim of the body, so that a cuvette is defined.

10. The nozzle according to one of the preceding claims, characterized in that the spray tube is formed under the wall by the intercalated spaces located radially outside the periphery of the wall between the internal faces of the body and the outer envelope of said ring .

11. The nozzle according to one of the preceding claims, characterized in that the support is extended downwards by a hub intended to be encased in the tank.

12. The nozzle according to one of the preceding claims, characterized in that the wall is made of silicone.

13. The nozzle according to one of the preceding claims, characterized in that the ring ensures, in the closed position, a state of pretension of the link element. SPRAY NOZZLE WITH CLOSURE MEMBRANE SUMMARY OF THE INVENTION The present invention relates to a nasal nozzle for the distribution and / or dosage of liquid pharmaceutical products, comprising a cylinder-shaped body (1) provided with a lower support (13) d support and connection to a reservoir likely to be puest under pressure and of an axial ejection duct (10) enclosing a central ring (2) and communicating, on the one hand, at its extremity. above, with a spray tube, and, on the other hand, at its lower end, with the reservoir, characterized in that the upper extremity of the expulsion conduit (10) is temporarily and hermetically sealed by a wall (111) which is integral with the upper part (1) of said body (1) and perpendicular to the conduit, being displaceable in a reversible manner under the action of the product, said wall is provided with a central hole (110) capable of being sealed in the closed position , by the forced support of a projection (20) integral with the ring (2), and attached to said body (1) peripherally by an elastically deformable link element (112) that allows, under pressure, the axial translation of said wall (111).