Distribution valve for nasal spray

Surgery – Liquid medicament atomizer or sprayer – Gas stream aspirating medicament from reservoir

Reexamination Certificate

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Details

C128S200140, C128S203280

Reexamination Certificate

active

06701916

ABSTRACT:

FIELD OF THE INVENTION
The invention consists in a distribution valve for nasal spray having a section of elliptical or oval shape and showing a distribution nozzle having elliptical or oval shape or slot shape.
PRIOR ART
Applying inside the nasal cavities drugs in “spray” form either for preventive purpose (for example, in order to prevent and/or mitigate allergic syndromes and/or their manifestations) or for curative purpose, for example to treat diseases of the nasal cavities (rhinitises, sinusitises, and so on) and/or to make the patient take by the nasal mucosas drugs assigned to carry out their action in other body regions is a well known and widely consolidated practice.
The drugs normally taken in “nasal spray” form and the pursued (or which may be pursued) aims by the intake of such drugs will not be further discussed here because known by themselves and however extraneous to the present invention; such drugs, normally contained in an aerosol bomb or other airtight container, are vehiculated by a fluid (gas, air, and so on) and they are applied to the nasal mucosa by a distribution valve fixed to the drug container.
In the present description, with “distribution valve” we mean globally the means, carried by the container, enabling to apply “in loco” the drug and the means (not further described because known by themselves) allowing to control and to dose the delivery of the drug.
In the distribution valves of known kind the means to apply “in loco” the drug normally include a cylindrical or truncated conical body, to be inserted into a nostril, at the end of which there is a round, very small sized, distribution nozzle normally located at the longitudinal symmetry axis of the above mentioned body: the drug is expelled under pressure (in a known by itself manner) through the distribution nozzle and the jet coming out from the distribution nozzle is directed varying the inclination angle of the longitudinal symmetry axis of the cylindrical or truncated conical body inside the nasal cavity.
Numerous studies and experimental checks showed that a drug is more effective if it is distributed into the nasal cavity in an extended, uniform and repeatable way, that is uniformly distributed on a wide zone of the nasal mucosa that is, however possible, the same on each application.
The distribution valves of known kind turned out not to be particularly suitable to satisfy such need, because:
the substantially axial direction of the jet having conical shape coming out from the distribution nozzle allows to spray a limited portion of the nasal mucosa, as shown in
FIG. 6
; in order to spray the whole nasal mucosa one has to spray the drug two or three times, varying the inclination angle of the longitudinal symmetry axis of the cylindrical or truncated conical body within the nasal cavity;
the substantially cylindrical or truncated conical shape of the body carrying the distribution nozzle fits poorly the substantially elliptical or oval section of a nostril (into which it may be inserted from time to time with different angle) and it does not allow therefore to direct, on each application, the jet supplied by the nozzle to the same portion of the nasal mucosa; moreover the need to obtain a uniform distribution of the drug on the whole mucosa of the nasal cavity varying the inclination angle of the longitudinal symmetry axis of the above mentioned body inside the nasal cavity involves (or may involve) the risk to damage the mucosa of the nasal septum or the nasal turbinates one, causing bleedings and/or other injuries.
The distribution valve for nasal spray object of the present invention allows to obtain a wider, more uniform and more repeatable, distribution of the medicament inside the nasal cavities proving to be free from the above mentioned drawbacks presented by the distribution valves of known kind.
SUMMARY OF THE INVENTION
The object of the present invention is a distribution valve for nasal spray including a body, to be inserted into a nostril, having a section of elliptical or oval shape (preferably having size equivalent to the nostril one); at the end of the above mentioned body of elliptical or oval section there is a distribution nozzle having elongated (elliptical or oval or slot shaped) form.
By elliptical or oval section we mean a section having a major symmetry axis and a minor symmetry axis, wherein the major axis has a length different from the minor axis one.


REFERENCES:
patent: 4513891 (1985-04-01), Hain et al.
patent: 4944429 (1990-07-01), Bishop et al.
patent: 5031800 (1991-07-01), Brunet
patent: 5505193 (1996-04-01), Ballini et al.
patent: 5829434 (1998-11-01), Ambrosio et al.
patent: 6065474 (2000-05-01), Coe
patent: 6418924 (2002-07-01), Poley et al.
patent: 2123252 (1973-01-01), None
patent: 1.211.726 (1960-03-01), None
patent: WO 99/49984 (1999-10-01), None

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