Dispensing – With cutter and/or punch – To form dispensing opening in container
Reexamination Certificate
1999-08-10
2001-11-27
Kaufman, Joseph A. (Department: 3754)
Dispensing
With cutter and/or punch
To form dispensing opening in container
C222S153050, C222S319000, C222S320000, C222S386000
Reexamination Certificate
active
06321942
ABSTRACT:
BACKGROUND OF THE INVENTION
U.S. Pat. No. 4,964,069, assigned to the assignee herein, describes a discharge device in which a pump cylinder and a resilient stop constructed in the manner of a snap locking mechanism. Before a partial stroke can be effected, it is necessary for the operator to apply a specific actuating pressure, so that after overcoming this pressure threshold, a liquid is discharged with a specific minimum force and speed. This construction ensures that an adequate pressure exists at the outset for atomizing the medium, and that the pump is actuated up to the end of its stroke. Consequently, the complete content of the medium reservoir or store, which simultaneously forms the pump cylinder, is discharged in one or two strokes. Such single or multiple dosing devices are important for the delivery of medicaments, which are particularly critical with respect to the dosage, contamination, conservation or other criteria.
Published PCT application No. WO 92/00812, assigned to the assignee herein, discloses the use of medium reservoirs for a single discharge stroke, which are closed by a stopper simultaneously serving as a piston, the stopper being perforated by a needle for actuation purposes.
FR-A-1 535 293 discloses a tamper preventer for aerosol valves, in which predetermined breaking points are provided between the cap carrying the nozzle and a flange-like bead which can be snapped onto the container closure cover. These breaking points break prior to the first use.
EP-B-521 022 discloses a two-compartment atomizer, in which the stroke of a thrust piston pump is limited by a rocker on the circumference of the casing which is advanced for a second stroke.
DE-U-29 601 047 discloses a pump atomizer, which is designed for two successive discharge strokes. For this purpose on the sleeve receiving the medium container forming the pump cylinder there are two predetermined breaking rings, which come into successive engagement.
The second predetermined breaking ring forms a stop for ending the first discharge stroke step.
SUMMARY OF THE INVENTION
The present invention is provided in a discharge device for flowable media using a thrust piston pump and enabling discharge to take place in at least two successive discharge stroke steps. In particular, each of the discharge strokes take place with a predetermined minimum pressure and the component of the dispenser are preferably so secured against one another that the two discharges strokes cannot be performed with a single actuation even on applying high forces.
The invention provides two destructible pressure point protectors, each of which requires a predetermined actuating force for the release thereof.
Thus, it is possible to spray into both nostrils of the patient a medicament, which has to act rapidly, in two successive strokes. This is particularly important for medicaments for the treatment of highly painful illnesses or attacks thereof, such as migraine headaches. The medicaments which have been developed for treating such illnesses are very expensive and must therefore be used in a very accurately dosed manner. Their absorption by means of the nasal mucosus is very good and acts rapidly, but should be uniformly absorbed by both nostrils in order to further increase the rapid action. It must in particular be ensured that patients, suffering from a migraine attack, are frustrated by the pain and consequently a reliable, uncomplicated function of the discharge device is vital. This is ensured by the multi-stroke discharge device according to the invention, which overcomes any external circumstances.
The pressure point protector can contain at least one predetermined breaking point. In a particularly preferred manner, it is provided on a snap-in ring, which includes destructible material bridges on a sleeve receiving the medium container and forming an actuation pusher. This snap-in ring makes it possible to provide the material bridges on one of the two parts to be joined together so that following the separation of the material bridges, the ring which is snapped onto the other part will remain thereon.
When the first discharge stroke step has been initiated and the first stroke is ended, preferably a stop is provided, whose stop elements are, for example, spokes in the vicinity of the ring. Thus, when the first stroke is ended, the part movable with respect to the base body, i.e. the actuating sleeve with the medium store, strikes against a fixed stop, which ensures that simultaneously the second discharge stroke step is not initiated. For this purpose initially an unlocking actuation is carried out, for example, by mutually turning the two parts movable relative to one another. Thus, the spokes separated from the ring in the meantime and remaining on the actuating sleeve can be turned into a position where they are in the vicinity of webs, which are in turn connected to the base body by predetermined breaking points. This turning position can be limited by projecting wall portions, in order to prevent excessive turning. If now a second actuation takes place, once again the predetermined breaking points between the web and the base body break, so that a second discharge stroke is performed with a minimum actuating force being carried out.
It is important, particularly for pharmaceutical applications, that the medium store is hermetically sealed up to the time of the initial use. This can be brought about through a medium store, usually a cylindrical glass ampoule, which is closed by a plug of a rubbery material, which is perforated by a hollow needle during the first discharge stroke and which consequently forms a type of outlet or delivery valve. The discharge channel connected by it, or formed by it, remains open following the first stroke, so that atomization can immediately start during the following second stroke.
WO 93/00172 discloses in the case of a disposable atomizer having a different construction a smaller cross-section delivery tubule connected to a support section.
Particularly when applying a medicament to the nostrils, it is often important to direct the spray jet onto therapeutically, particularly favorable points. Thus, a further aim of the invention is to so construct an applicator that application is possible to specific points within body orifices, including particularly difficultly accessible points. To this end, a thin, long delivery or discharge tubule with a greatly reduced diameter, on whose end is located the outlet port, preferably in the form of a spray nozzle, can be connected to a connecting piece of the base body.
This makes it possible to introduce the delivery tubule into a nose channel, particularly the inner nostril, for the delivery of a medicament, preferably a vaccine or immunizing agent against common colds, such as influenza. It is admittedly known to apply pharmaceuticals to the nasal mucosus, so as to permit rapid absorption without burdening the gastrointestinal tract, but in the case of many medicaments, particularly the aforementioned vaccines against common colds, it is necessary or at least advantageous to apply them to specific nasal cavity areas, e.g. to the conchae nasi. The described delivery tubule shape permits the introduction into said area.
In order to permit an introduction of the delivery tubule into the corresponding curved areas of the nasal cavity, it can have a bend, such as a curve, a kink, etc. or can be angled away from the connecting piece. It can itself be elastically or plastically flexible, i.e. pliable, so that on introduction into a nose channel it adapts thereto.
In the case of a relatively long tubule, which due to the small diameter of generally below 5 mm. (preferably 2 to 4 mm) for a length of more than 10 mm (preferably 20 to 30 mm), cannot contain the actual applicator, i.e. usually a thrust piston pump, there is a problem of dead space, which not only impedes the flow of the normally very valuable medicament, but in particular impedes the spontaneity of pressure buildup by widening under pump pressure. This problem can be solved accordin
Fuchs Karl-Heinz
Krampen Gerald
Merk Hans
Ing. Erich Pfeiffer GmbH
Kaufman Joseph A.
Quarles & Brady LLP
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