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1. WO2007010579 - DEVICE FOR ADMINISTERING FLUIDS IN NEBULISED FORM

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Device for administering fluids in nebulised form
DESCRIPTION
Field of the invention
The present invention relates to a device for administering fluids in nebulised form (aerosols) via nasal and/or oral channels. These devices are also known in the field of aerosol appliances as "nebuliser bulbs".
Technical background
Currently known devices for the administration of fluids in nebulised or aerosol form comprise a first body adapted to contain the fluid to be administered, a nozzle adapted to nebulise the fluid by the Venturi effect, a second body or cover detachably engaged with the first body and forming, with the first body and the nozzle, an aerosol particle collection chamber.

The second body or cover bears a guide connection, communicating with the collection chamber, in order to convey the nebulised fluid into the user's nasal cavities and to enable a correct position of use. The device configured in this way is connected to a compressor or a like generator of gas or pressurised air needed for the formation of the aerosol.
In the prior art, the end of the nozzle adapted to nebulise the fluid is inside the collection chamber in a coaxial position with respect to the connection borne by the cover and at an appropriate distance from the internal mouth of the connection in order to channel the finest particles of the aerosol jet into the nasal/oral cavities and to collect the coarser and peripheral particles on the inner walls of the cover.
In practice, the peripheral particles spread irregularly over the inner walls of the cover or second body forming droplets which slide, under the effect of gravity, along the walls and collect at the base of the nebulisation nozzle and, as a result of the Venturi effect, are nebulised again; the inner walls of the collection chamber are appropriately shaped to promote the flow of fluid to the base of the nozzle.
By means of this solution, the fluid not supplied during the initial stage of actuation of the device is largely re-used. However, at least part of these fluids adheres, in the prior known devices, as a result of molecular adhesion, to the walls of the collection chamber and the ducts within the nebulisation nozzle, thereby reducing the quantity of fluid administered, this reduction being the greater, the larger the surfaces with which the fluid comes into contact.
Moreover, the use in therapy of fluid drugs having viscosity values higher than those normally possessed by drugs conventionally administered nasally, has aggravated this drawback; the quantity of residual fluid is in practice the greater, the greater the viscosity of the fluid administered.
Viscous drugs in practice show a high level of molecular adhesion and therefore tend to adhere more forcefully to the surfaces on which they are deposited; as this physical property facilitates adhesion to the mucous membranes inside the nose, increasing the length of time that it remains in situ and the gradual osmotic absorption of the drug, the administration of drugs in aerosol form is particularly advantageous. However, higher adhesion levels have the drawback of reducing the quantity of the drug nebulised. Using the prior art, it will be appreciated that the particles of the aerosol jet which are spread on the inner walls of the bulb, in particular on the inner surfaces of the cover, tend to continue to adhere thereto and can slide again into the collection chamber only when large droplets are formed, thereby reducing the quantity of the drug actually administered.
A further drawback arising from the use of viscous drugs is the problem of cleaning and sterilising the device after each administration.
Description of the invention
The technical problem underlying the present invention is that of providing a device for administering fluids in nebulised form (aerosols) via nasal channels which is structurally and functionally designed to remedy the drawbacks described with respect to the cited prior art.
In respect of this problem, a first object of the invention is to provide a device for administering a fluid in nebulised form, via nasal channels, able to maximise the quantity of fluid administered to the user and to reduce to a minimum the quantity of fluid which is not used.
A further object of the invention is to provide a device able efficiently to administer particularly viscous fluids.
A further object of the invention is to provide a device suited to embodiments of the "throwaway" or disposable type. A further object of the invention is to provide a device which has a smaller number of components and which can be produced in an economically advantageous manner.
A further object of the invention is to provide a device having smaller dimensions which is readily portable.
The technical problem set out above is resolved and these objects are achieved by a device for administering fluids in nebulised form, via nasal channels, in accordance with the accompanying claims.
Brief description of the drawings The characteristic features and advantages of the invention are set out in detail in the following detailed description of some preferred, but non-limiting, embodiments thereof, given by way of non-limiting example, with reference to the accompanying drawings, in which:
Figs. 1 and 2 are perspective views of a first embodiment of the invention respectively prepared for sale and ready for use;
Figs. 3 and 4 are exploded views, respectively in elevation and in axial section, of the device of the preceding Figures;
Fig. 5 is a view in section of the device assembled for use;
Figs. 6 and 7 are views in section of a first and a second variant respectively of the device of the invention;
Fig. 8 is an exploded view in section of a third variant of the device; Fig. 9 is a view in section of a fourth variant of the same device assembled.
Preferred embodiments of the invention
In Figs. 1 to 5, a device for administering fluids in nebulised form is shown overall by 1 and comprises a bulb 2 in which a collection chamber 3 for the fluid to be nebulised is provided. A duct 4 having a first end 5 which may be connected, in use, to a compressor or like device supplying a flow of pressurised gas via tubing (not shown) extends through the bulb 2, passing through the chamber 3, with a section 6 of the duct projecting therebeyond by a non-negligible amount.
An end wall 8 comprising a through hole 9 coaxial with the duct 4 is provided at the end of the section 6. A recess 10 extending up to the end wall 8 is provided at this same end, externally to the duct 4.

A cup formation 11 is provided unitary with the duct 4, the external shell 12 of this formation being threaded in order to engage the corresponding threaded inner shell 13 of a cover 14. The cover and cup formation 11, 14 form the collection chamber 3 for the fluid to be nebulised. In a first embodiment of the invention, shown in Figs. 1 to 5, the cover 14 is rigid with a tubular member 15 able to be fitted as a hood on the duct 4, coaxially thereto but radially spaced so that a space 16 is provided between the outer shell of the duct 4 and the inner shell of the tubular member 15 and extends up to the vicinity of the base 17 of the chamber 3 to form a riser 18 adapted to take up the fluid to be administered in aerosol form. The tubular member is closed, in a similar manner to the duct 4, on the side opposite the base of the chamber 3 by an end wall 19 provided with a through hole 20 coaxial with the hole 9 of the duct 4. The wall 19 is kept spaced from the wall 8 by ribs 19a. This provides a nebulisation nozzle shown overall by 21 and supplied via the riser 18 as a result of the Venturi effect in order to nebulise the treatment fluid in the patient's nasal (or oral) cavity.
In order to facilitate correct nebulisation in the nasal cavity and at the same time to protect the nozzle 21 against accidental shocks, the cover bears a tubular sleeve 23 extending coaxially to the tubular member 15 beyond the nozzle itself in order form a nasal supply guide. This guide is brought to the nostril and may be partially inserted therein so that all the nebulised fluid is correctly conveyed into the nasal cavity. In order to prevent this from causing overpressures in the user's nose, in particular in the case of small nostrils in which this guide may be tightly inserted, i.e.

without radial play, it is provided for at least one passage 26 to be provided between the tubular sleeve 23 and the tubular member 15 in order to balance the pressure generated in the nasal cavity with the pressure in the chamber 3 which is in turn balanced in the manner described below with external atmospheric pressure.
As a result of its geometry, the nozzle 21 supplies nebulised fluid with a substantially conical configuration of angle A. To prevent the nebulised fluid from being retained by the inner wall of the nasal supply guide, the geometry and extension of the tubular sleeve 23 and of the nozzle are selected such that the nebulisation cone of the nozzle is projected entirely externally to the nasal supply guide, directly into the patient's nasal cavity.

The cover 14 is lastly provided with a raised edge 24, concentric with the sleeve 23 externally thereto and provided with through openings 25. This helps to collect and return any nebulised fluid which may have dripped outside the sleeve 23 to the chamber 3 for further supply. The return to the chamber 3 is facilitated by the depression generated as a result of the Venturi effect in this chamber by the nozzle, comprising a continuous inlet of air into the chamber 3 via the openings 25. The latter are also adapted to balance the pressure in the chamber 3 in order to prevent overpressures in the user's nostril when the nasal guide is inserted tightly therein.
The assembly of components described is further supplemented by an auxiliary cover, shown by 30, adapted to be fitted on the cup formation 11 and on the duct 4 as a replacement for the cover 14 in order to close it until the bulb 2 needs to be used. As well as closing the chamber 3, the cover 30 is provided with a blind tubular section 31 which, by engaging the recess 10 of the duct 4, closes the chamber 3 in a leak-tight manner. In this way, the device 1 may be pre-packaged with appropriate doses of treatment fluid and sold in this way.
Some variants of the device of the invention are shown respectively by IOOA and IOOB in Figs. 6 and 7, by 200 in Fig. 8 and by 300 in Fig. 9. In all these variants, details analogous to those of the first embodiment or technically equivalent bear the same reference numerals.
The variant IOOA differs from the first embodiment solely in that the tubular member 115 used in the formation of the nozzle 21 and its supply riser is formed separately from the cover 14 and is fitted on the duct 4 and kept spaced therefrom in order to form the space 16 by means of raised portions, spacers or ribs (not shown).
The variant IOOB is identical to the preceding variant except that the cover is not provided with a tubular sleeve adapted to act as a nasal supply guide.
The variant 200 differs from the first embodiment in that the cover 214 and the auxiliary cover 230 are snap on the cup formation 211 to close the chamber 3 by using a collar 201 provided with an annular recess 202 in a corresponding seat 203 provided with a corresponding annular relief 204. The variant 300 differs from the embodiment 200 in that the nozzle

21 is prolonged by a short section of tubular sleeve 301 provided with radial apertures 302 adapted to balance the pressure to which the user's nostril is subject and the pressure in the chamber 3 in order to prevent undesirable overpressures.