Surgery – Instruments – Oral pacifier
Reexamination Certificate
2000-09-14
2003-06-10
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Oral pacifier
Reexamination Certificate
active
06575999
ABSTRACT:
The invention relates to a pacifier nipple comprising a subdivided elastomeric nipple body including a fastening portion, a neck portion and a head portion wherein a receiving space for substances, e.g. a medicament for oral administration, is provided.
The oral administration of medicaments or similar substances to infants often is difficult since the children refuse to take these substances because of their unpleasant taste. Moreover, as a rule tablets cannot be administered to infants because of the risk of suffocation, and in some instances it may be necessary for the active ingredient of the medicament to be released gradually, with the infants, however, being unable to suck tablets or to chew them.
In DE 3,503,777 A, a medicament dispensing nipple has been proposed in which the interior of the entire nipple body forms a receiving space for a medicament; the nipple body is perforated over approximately half its longitudinal extension, and at its rear side it communicates with a refilling channel via which the respective medicament can be introduced into the nipple body. The refilling channel has an associated detachable closing cap. Nipples of similar principle have, furthermore, been proposed in U.S. Pat. No. 5,078,734 A as well as in WO 91/04 727 A.
One disadvantage is that depending on the position of the head of the child who uses the pacifier provided with the medicament dispensing nipple, the medicament may also remain in the rear or outer region of the nipple body and thus outside the mouth. Accordingly, an embodiment has already been proposed in WO 91/04 727 A in which the medicament is lodged between two layers of the nipple body in the front or head portion thereof. However, this is a nipple which can be used only once, whereas it is sought to be able to use a pacifier comprising a dispenser nipple over a longer period of time, also for a more frequent medicament delivery.
The disadvantage of the incomplete administration of the respective medicament during sucking on the pacifier also applies to the pacifier according to CH 684 160 A. The interior of the nipple body of this pacifier is subdivided by a separating wall, with the respective medicament being received in the interior of the neck portion of the nipple body which is separated from the head or palate portion by the separating wall. To deliver the medicament, numerous small perforations are provided in this neck portion.
Yet above all also here it is a disadvantage—just with all the other known nipples with the possibility of administering a medicament—that the respective medicament is re-filled from the rear or outer side via the fastening portion of the nipple body in the region of the pacifier shield, if the pacifier is used several times as a medicament dispenser, and this requires attaching removable closing parts, such as plugs or the like. Accordingly, this results in releasable pacifier parts, and the pacifier embodiments altogether are not disassembly-proof, resulting in a substantial risk that the infant will swallow parts of the pacifier after an accidental disassembly or detachment of parts thereof.
Also cleaning of the known nipple bodies in their interior after a medicament has been administered is only possible with the greatest difficulties, and the production of the nipple body of the pacifier according to CH 684 160 A with the closed head or palate portion is also difficult.
As has already been implied before, it has been a wish for some time to design comforters or pacifiers as disassembly-proof and orthodontologically suitable as possible. In this connection mention may be made, e.g., of AT 338 440 B.
The invention thus has as its object to provide a nipple of the above defined type, in which the medicament to be administered need not be introduced from the rear side of the exterior of the pacifier, through the attachment portion of the nipple body, so that this nipple is suitable for use in a disassembly-proof pacifier, such as the one according to the afore-mentioned AT 338 440 B; moreover, the nipple is to be easy to produce and also easy to clean, and filling with a medicament nevertheless shall not pose any problems.
The pacifier nipple according to the invention of the initially defined type is characterized in that the receiving space is provided in the head portion that is separated from the neck portion and that the head portion is provided with a sealing lip abutting on the remaining nipple body and liftable therefrom.
In the pacifier nipple according to the invention thus the respective medicament to be administered or, generally, the substance is received in the front head portion of the nipple body, and thus it is ensured that the child will take in this substance gradually during sucking when using the pacifier. For filling the receiving space in the head portion, the sealing lip thereof may be lifted off the remaining nipple body to the appropriate extent. The administration of the substance to the infant may also be effected by a—slighter—lifting of the sealing lip, the extent of lifting being controllable by the intensity of sucking. The present nipple is easy and well to be cleaned if the sealing lip is lifted off the remaining nipple body or is reversed.
Other than the nipple pacifiers according to the prior art, this nipple configuration is also suitable for collecting the saliva of the infant, e.g. for medical tests, in an advantageous manner, since during sucking, by lifting the sealing lip at the “valve seat” formed by the remaining nipple body, saliva may get past the “valve seat” into the interior of the head portion, i.e. into its receiving space, in sufficient amounts. There, it is also advantageous to provide a foam material body in the receiving space which takes up the saliva like a sponge. This foam material body may, e.g., have the shape of a slit ring.
An embodiment has proven particular advantageous in which the head portion comprises a hood connected with the remaining nipple body and adjoining the remaining nipple body at least over part of its periphery via a separating line, the hood being outwardly reversible. The nipple may be produced in a state in which the hood is outwardly reversed so that in that state there are no overlapping parts, which simplifies the production in one piece. The preferred integral configuration of the nipple body not only has the advantage of a simple production, but moreover, also that of being more resistant against an undesired separation which, e.g., might happen if the nipple body is produced in parts which are connected later on, such as by gluing.
Accordingly, it is to be particularly preferred if the hood is integrally connected with the remaining nipple body.
Although it would be possible to connect the hood in one piece with the remaining nipple body via a more or less strip-shaped outer web that forms part of the nipple body jacket, it is particularly suitable with a view to the attainable higher strength as well as, finally, also the simpler mould design and production if, via an axial, central shaft part, the hood is connected with a front-end wall that closes the neck portion. With such a configuration, the hood with its entire free rim which normally faces the remaining nipple body, can be reversed in the direction away from the fastening and neck portions of the nipple body, so that then a reversed “cup” is present which is connected in one piece with the remaining nipple body via a central “stem”, the shaft part. There, it is furthermore advantageous if the shaft part has at least one opening for the clamping retention of medicaments in the form of tablets or capsules.
The remaining nipple body suitably has a step- or shoulder-shaped abutment surface as “valve seat” at the periphery of the separating wall where the free rim of the hood rests in its normal position. However, to facilitate the delivery of the medicament received in the receiving space, i.e. in the interior of the hood, a passage of appropriately small cross-section may be provided in this abutment or sealing region so as not to cause an
Bamed AG
Ho (Jackie ) Tan-Uyen T.
Milano Michael J.
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