Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-06-02
2001-05-08
Nguyen, Anh-Tuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S094010
Reexamination Certificate
active
06228070
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a device for irrigating or washing the meatus of the nasal cavities and the rhinopharynx.
The nasal cavities have the function of humidifying, purifying and warming the inhaled air and of dehumidifying and cooling the exhaled air. This system can suffer damages and thus become inefficacious as a consequence of the development of a pathology that can cause nasal respiratory difficulty because of inflammation of the nasal mucosa, stagnation of mucous or mucopurulent secretions, dust, allergens. In these circumstances the removal of the secretions which can be present inside the nasal cavities and also a stimulation of the nasal mucosa by means of a nasal washing, are necessary.
The substances that can be currently introduced into the nasal cavities can be either in form of drops or in nebulized form; in the first case it is necessary to introduce the solution with the head leaned backwards while the removal of the washing product occurs by forced expiration through the nasal cavities, or by deglutition (the head of the subject has to be leaned backwards in order to avoid that during the introduction the solution comes out by infiltrating between the nasal vestibule and the opening of the container of the solution); whereas in the second case the nebulization occurs with spray bottles that often use propellents that can be irritating for the nasal mucosa.
In the typologies of the mentioned interventions, the amount of substance that can be introduced into the nasal cavities is always very small.
The only equipments that allow to carry out an efficacious washing of the nasal cavities and of the rhinopharynx with great amounts of solution are of thermal or ambulatory type and therefore rather expensive; such equipments require, for their use, qualified personnel and involve from time to time the sterilization of some components. Other components, not intended to be cleaned after each use, yet are subject to be in contact and to become dirty with the substances removed from the washing operations. The user, or the authorized personnel, is then subjected, during the washing operation, to dirty the fingers that grip the delivery nozzle of the solution.
EP 0 319 501 (Loefstedt) discloses a device for administering a solution into a nasal cavity comprising a compressible container containing the solution to be administered and an olive shaped conical nozzle to be placed into the nose. The solution is pumped via the nozzle into the nose by squeezing the container.
The nozzle is a truncated half olive, which must be conical and has a circular base; the diameter of the base is 15-23 mm, preferably 19 mm. The upper part of the nozzle, which is in contact with the nostril, is also conical and has a circular opening with a diameter preferably between 3-10 mm.
Said upper part of the olive is inserted into the nose and the nasal cavity can be completely filled with the solution by pumping it by compressing the container, then the solution from the nasal cavity returns into the container by releasing the container.
The device disclosed by EP 0 319 501 shows several serious drawbacks. The upper part of the nozzle has a truncated conical shape which does not fit the shape of the nostril (the nostrils have substantially oval or elliptical openings) and therefore must be pushed inside the nose (see
FIGS. 3 and 4
) by the user with the risk of redness of the nostril, uncomfortable position, pain and damage of the nasal mucosa with risk of damages of the nasal septum and of the inferior turbinates. Then, when the solution from the nasal cavity returns into the container, it contains mucous or substances secreted by the nasal cavity and, as consequence, it plugs the opening of the nozzle preventing the solution to return into the container.
The nozzle described has a central opening and it is inserted into the nose without a specific orientation. Desiring to direct the solution stream toward specific portions of the nasal cavity, the operator (especially if without specific training or knowledge) tends to move the upper part of the nozzle inside the nasal cavity with serious risks of damages of the nasal mucosa with possibility of epistaxis, and other damages as above said.
Then, the solution is administered into the nasal cavity by pumping it from the compressible container. In case of a strong compression (pressure) of the container, it could determine a strong stream of the solution into the nasal cavity with risk of serious internal damages and rupture of the wall of vessels.
U.S. Pat. No. 4,660,555 (Payton) discloses an oxygen delivery and administration system comprising a nosepiece having a conical section (with a circular base) and a truncated tip, completely inserted within the nose, having a primary axial oxygen passageway and lateral secondary oxygen passageways. Said lateral secondary passageways, directed not toward the meatus but toward the internal lateral walls of the nasal cavity, is provided in case the primary passageway becomes plugged with mucous.
The nozzle of U.S. Pat. No. 4,660,555 is disclosed only for the administration of oxygen; in fact its structure could not suggest the use of said nozzle for the administration of a solution into the nasal cavity. Further, the nozzle requiring to be inserted completely into the nose, and comprises an anular skirt which extends rearwardly pushing on the vestibule preventing the nozzle coming out from the nose. These technical features of the nozzle necessarily cause serious damages to the mucosa, redness, bleeding and risk of perforation of the nasal septum.
In practice no equipment for domestic use exists on the market that allow to sprinkle remarkable amounts of liquids into the nasal cavities and the rhinopharynx in an easy, simple, inexpensive and hygienic manner and without any risk due to a wrong use.
SUMMARY OF THE INVENTION
The aim of the present invention is to obviate the drawbacks of conventional devices, by providing a device for a correct positioning to the nostril, and for specifically irrigating or washing the three meatus of the nasal cavities and the rhinopharynx that allows to carry out such operations in a simple and hygienic way.
Within the scope of this aim, another object of the present invention is to provide a device which is structurally simple, easy to be manufactured, safe in use, efficacious in operation, and also having a relatively low cost.
This aim and these objects are achieved by the present device for correctly and specifically irrigating or washing the meatus of the nasal cavities and the rhinopharynx which comprises a bell-shaped nozzle which is adapted to be sealingly pressed to one of nostrils of the user, who places his head slightly leaned forwards or sideways, said nozzle having elliptical shaped sections orthogonal to the longitudinal axis of the nozzle, said sections having a major symmetry axis (a) and a minor axis (b) of different length (as clearly shown in FIGS.
2
and
3
). The nozzle according to the invention comprises a tip end, which is sealingly pressed to the nostril, and three holes arranged at the tip end of the nozzle for the outflow of a solution toward the nasal cavities, these three holes being radially arranged on the symmetry plane which includes the major symmetry axes (a) of said nozzle.
Each of the three holes communicates with a tubular joint, positioned inside the nozzle and connected to a tube which connects the nozzle to a bag or the like adapted to contain the washing solution. The bag or the like supplies, advantageously by gravity, the solution to be sprinkled, the solution and the washing product flowing along the meatus of a nasal cavity and through the rhinopharynx into the contralateral nasal cavity and flowing outside through the vestibule of the contralateral nasal cavity.
The devices described in the state of the art are conical nozzles with a circular base and therefore these devices when placed into the nostril do not have a specific orientation and, as consequence, the holes of the truncated nozz
Hedman & Costigan ,P.C.
Medical International Licensing, N.V.
Nguyen Anh-Tuan T.
Thanh Loan H.
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